Hospital Medicine

The Pediatric Hospital Medicine Core Competencies were first published in 2010 to help define a specific body of knowledge and measurable skills needed to practice high quality care for hospitalized pediatric patients across all practice settings.¹ Since then, the number of practicing pediatric hospitalists has grown to a conservative estimate of 3,000 physicians and the scope of practice among pediatric hospitalists has matured.² Pediatric hospitalists are increasingly leading or participating in organizational and national efforts that emphasize interprofessional collaboration and the delivery of high value care to hospitalized children and their caregivers—including innovative and family-centered care models, patient safety and quality improvement initiatives, and research and educational enterprises.^3-8 In response to these changes, the American Board of Medical Specialties designated Pediatric Hospital Medicine (PHM) as a pediatric subspecialty in 2016.

The field of PHM in the United States continues to be supported by three core societies—Society of Hospital Medicine (SHM), American Academy of Pediatrics (AAP), and Academic Pediatric Association (APA). Together, these societies serve as tri-sponsors of the annual Pediatric Hospital Medicine national conference, which now welcomes over 1,200 attendees from the United States and abroad.⁹ Each society also individually sponsors a variety of professional development and continuing medical education activities specific to PHM.

In addition, pediatric hospitalists often serve a pivotal role in teaching learners (medical students, residents, and other health profession students), physician colleagues, and other healthcare professionals on the hospital wards and via institutional educational programs. Nearly 50 institutions in the United States offer graduate medical education training in PHM.¹⁰ The PHM Fellowship Directors Council has developed a standardized curricular framework and entrustable professional activities, which reflect the tenets of competency-based medical education, for use in PHM training programs.^11-13

These changes in the practice environment of pediatric hospitalists, as well as the changing landscape of graduate and continuing medical education in PHM, have informed this revision of The PHM Core Competencies. The purpose of this article is to describe the methodology of the review and revision process.

Revision

The PHM Core Competencies: 2020 Revision provide a framework for graduate and continuing medical education that reflects the current roles and expectations for all pediatric hospitalists in the United States. The acuity and complexity of hospitalized children, the availability of pediatric subspecialty care and other resources, and the institutional orientation towards pediatric populations vary across community, tertiary, and children’s hospital settings. In order to unify the practice of PHM across these environments, The PHM Core Competencies: 2020 Revision address the fundamental and most common components of PHM which are encountered by the majority of practicing pediatric hospitalists, as opposed to an extensive review of all aspects of the field.

The compendium includes 66 chapters on both clinical and nonclinical topics, divided into four sections—Common Clinical Diagnoses and Conditions, Core Skills, Specialized Services, and Healthcare Systems: Supporting and Advancing Child Health (Table 1). Within each chapter is an introductory paragraph and learning objectives in three domains of educational outcomes—cognitive (knowledge), psychomotor (skills), and affective (attitudes)—as well as systems organization and improvement, to reflect the emphasis of PHM practice on improving healthcare systems. The objectives encompass a range of observable behaviors and other attributes, from foundational skills such as taking a history and performing a physical exam to more advanced actions such as participating in the development of care models to support the health of complex patient populations. Implicit in these objectives is the expectation that pediatric hospitalists build on experiences in medical school and residency training to attain a level of competency at the advanced levels of a developmental continuum, such as proficient, expert, or master.¹⁴

Project Initiation

Revision of The PHM Core Competencies: 2020 Revision began in early 2017 following SHM’s work on The Core Competencies in Hospital Medicine 2017 Revision.¹⁵ The Executive Committee of the SHM Pediatrics Special Interest Group (SIG) supported the initiation of the revision. The 3 editors from the original compendium created an initial plan for the project that included a proposed timeline, processes for engagement of previously involved experts and new talent, and performance of a needs assessment to guide content selection. The Figure highlights these and other important steps in the revision process.

Editor and Associate Editor Selection

The above editors reviewed best practice examples of roles and responsibilities for editor and associate editor positions from relevant, leading societies and journals. From this review, the editors created an editorial structure specifically for The PHM Core Competencies: 2020 Revision. A new position of Contributing Editor was created to address the need for dedicated attention to the community site perspective and ensure review of all content, within and across chapters, by a pediatric hospitalist who is dedicated to this environment. Solicitation for additional editors and associate editors occurred via the SHM Pediatrics SIG to the wider SHM membership. The criteria for selection included active engagement in regional or national activities related to the growth and operations of PHM, strong organizational and leadership skills, including the ability to manage tasks and foster creativity, among others. In addition, a deliberate effort was made to recruit a diverse editorial cohort, considering geographic location, primary work environment, organizational affiliations, content expertise, time in practice, gender, and other factors.

Chapter Topic Selection

The editors conducted a two-pronged needs assessment related to optimal content for inclusion in The PHM Core Competencies: 2020 Revision. First, the editors reviewed content from conferences, textbooks, and handbooks specific to the field of PHM, including the conference programs for the most recent 5 years of both the annual PHM national conference and annual meetings of PHM’s 3 core societies in the United States—SHM, AAP, and APA. Second, the editors conducted a needs assessment survey with several stakeholder groups, including SHM’s Pediatrics and Medicine-Pediatrics SIGs, AAP Section on Hospital Medicine and its subcommittees, APA Hospital Medicine SIG, PHM Fellowship Directors Council, and PHM Division Directors, with encouragement to pass the survey link to others in the PHM community interested in providing input (Appendix Figure). The solicitation asked for comment on existing chapters and suggestions for new chapters. For any new chapter, respondents were asked to note the intended purpose of the chapter and the anticipated value that chapter would bring to our profession and the children and the caregivers served by pediatric hospitalists.

The entire editorial board then reviewed all of the needs assessment data and considered potential changes (additions or deletions) based on emerging trends in pediatric healthcare, the frequency, relevance, and value of the item across all environments in which pediatric hospitalists function, and the value to or impact on hospitalized children and caregivers. Almost all survey ratings and comments were either incorporated into an existing chapter or used to create a new chapter. There was a paucity of comments related to the deletion of chapters, and thus no chapters were entirely excluded. However, there were several comments supporting the exclusion of the suprapubic bladder tap procedure, and thus related content was eliminated from the relevant section in Core Skills. Of the 66 chapters in this revision, the needs assessment data directly informed the creation of 12 new chapters, as well as adjustments and/or additions to the titles of 7 chapters and the content of 29 chapters. In addition, the title of the Specialized Clinical Services section was changed to Specialized Services to represent that both clinical and nonclinical competencies reside in this section devoted to comprehensive management of these unique patient populations commonly encountered by pediatric hospitalists. Many of these changes are highlighted in Table 2.

Author selection

Authors from the initial work were invited to participate again as author of their given chapter. Subsequently, authors were identified for new chapters and chapters for which previous authors were no longer able to be engaged. Authors with content expertise were found by reviewing content from conferences, textbooks, and handbooks specific to the field of PHM. Any content expert who was not identified as a pediatric hospitalist was paired with a pediatric hospitalist as coauthor. In addition, as with the editorial board, a deliberate effort was made to recruit a diverse author cohort, considering geographic location, primary work environment, time in practice, gender, and other factors.

The editorial board held numerous conference calls to review potential authors, and the SHM Pediatrics SIG was directly engaged to ensure authorship opportunities were extended broadly. This vetting process resulted in a robust author list and included members of all three of PHM’s sponsoring societies in the United States. Once participation was confirmed, authors received an “author packet” detailing the process with the proposed timeline, resources related to writing learning objectives, the past chapter (if applicable), assigned associate editor, and other helpful resources.

Internal and External Review Process

After all chapters were drafted, the editorial board conducted a rigorous, internal review process. Each chapter was reviewed by at least one associate editor and two editors, with a focus on content, scope, and a standard approach to phrasing and formatting. In addition, the contributing editor reviewed all the chapters to ensure the community hospitalist perspective was adequately represented.

Thirty-two agencies and societies were solicited for external review, including both those involved in review of the previous edition and new stakeholder groups. External reviewers were first contacted to ascertain their interest in participating in the review process, and if interested, were provided with information on the review process. Robust feedback was received from the APA Hospital Medicine SIG, SHM Pediatrics and Medicine-Pediatrics SIGs, Association of Pediatric Program Directors Curriculum Committee, and 20 AAP committees, councils, and sections.

The feedback from the external reviewers and subsequent edits for each chapter were reviewed by at least one associate editor, two editors, and the contributing editor. Authors were engaged to address any salient changes recommended. As the final steps in the review process, the SHM Board of Directors approved the compendium and the APA provided their endorsement.

This second edition of The PHM Core Competencies: 2020 Revision addresses the knowledge, skills, attitudes, and systems organization and improvement objectives that define the field of pediatric hospital medicine and the leadership roles of pediatric hospitalists. This compendium reflects the recent changes in the practice and educational environments of pediatric hospitalists and can inform education, training, and career development for pediatric hospitalists across all environments in which comprehensive care is rendered for the hospitalized child. Future work at the local and national level can lead to development of associated curricula, conference content, and other training materials.

Acknowledgments

We wish to humbly and respectfully acknowledge the work of the authors, editors, and reviewers involved in the creation of the first edition, as well as this revision, of The PHM Core Competencies. In addition, we are grateful for the input of all pediatric hospitalists and other stakeholders who informed this compendium via contributions to the needs assessment survey, conference proceedings, publications, and other works. Finally, we acknowledge the support and work of SHM project coordinator, Nyla Nicholson, the SHM Pediatrics SIG, and the SHM Board of Directors.

Disclosures

SHM provided administrative support for project coordination (N. Nicholson). No author, editor, or other involved member received any compensation for efforts related to this work. There are no reported conflicts of interest.

The Pediatric Hospital Medicine Core Competencies were first published in 2010 to help define a specific body of knowledge and measurable skills needed to practice high quality care for hospitalized pediatric patients across all practice settings.¹ Since then, the number of practicing pediatric hospitalists has grown to a conservative estimate of 3,000 physicians and the scope of practice among pediatric hospitalists has matured.² Pediatric hospitalists are increasingly leading or participating in organizational and national efforts that emphasize interprofessional collaboration and the delivery of high value care to hospitalized children and their caregivers—including innovative and family-centered care models, patient safety and quality improvement initiatives, and research and educational enterprises.^3-8 In response to these changes, the American Board of Medical Specialties designated Pediatric Hospital Medicine (PHM) as a pediatric subspecialty in 2016.

The field of PHM in the United States continues to be supported by three core societies—Society of Hospital Medicine (SHM), American Academy of Pediatrics (AAP), and Academic Pediatric Association (APA). Together, these societies serve as tri-sponsors of the annual Pediatric Hospital Medicine national conference, which now welcomes over 1,200 attendees from the United States and abroad.⁹ Each society also individually sponsors a variety of professional development and continuing medical education activities specific to PHM.

In addition, pediatric hospitalists often serve a pivotal role in teaching learners (medical students, residents, and other health profession students), physician colleagues, and other healthcare professionals on the hospital wards and via institutional educational programs. Nearly 50 institutions in the United States offer graduate medical education training in PHM.¹⁰ The PHM Fellowship Directors Council has developed a standardized curricular framework and entrustable professional activities, which reflect the tenets of competency-based medical education, for use in PHM training programs.^11-13

These changes in the practice environment of pediatric hospitalists, as well as the changing landscape of graduate and continuing medical education in PHM, have informed this revision of The PHM Core Competencies. The purpose of this article is to describe the methodology of the review and revision process.

Revision

The PHM Core Competencies: 2020 Revision provide a framework for graduate and continuing medical education that reflects the current roles and expectations for all pediatric hospitalists in the United States. The acuity and complexity of hospitalized children, the availability of pediatric subspecialty care and other resources, and the institutional orientation towards pediatric populations vary across community, tertiary, and children’s hospital settings. In order to unify the practice of PHM across these environments, The PHM Core Competencies: 2020 Revision address the fundamental and most common components of PHM which are encountered by the majority of practicing pediatric hospitalists, as opposed to an extensive review of all aspects of the field.

The compendium includes 66 chapters on both clinical and nonclinical topics, divided into four sections—Common Clinical Diagnoses and Conditions, Core Skills, Specialized Services, and Healthcare Systems: Supporting and Advancing Child Health (Table 1). Within each chapter is an introductory paragraph and learning objectives in three domains of educational outcomes—cognitive (knowledge), psychomotor (skills), and affective (attitudes)—as well as systems organization and improvement, to reflect the emphasis of PHM practice on improving healthcare systems. The objectives encompass a range of observable behaviors and other attributes, from foundational skills such as taking a history and performing a physical exam to more advanced actions such as participating in the development of care models to support the health of complex patient populations. Implicit in these objectives is the expectation that pediatric hospitalists build on experiences in medical school and residency training to attain a level of competency at the advanced levels of a developmental continuum, such as proficient, expert, or master.¹⁴

Project Initiation

Revision of The PHM Core Competencies: 2020 Revision began in early 2017 following SHM’s work on The Core Competencies in Hospital Medicine 2017 Revision.¹⁵ The Executive Committee of the SHM Pediatrics Special Interest Group (SIG) supported the initiation of the revision. The 3 editors from the original compendium created an initial plan for the project that included a proposed timeline, processes for engagement of previously involved experts and new talent, and performance of a needs assessment to guide content selection. The Figure highlights these and other important steps in the revision process.

Editor and Associate Editor Selection

The above editors reviewed best practice examples of roles and responsibilities for editor and associate editor positions from relevant, leading societies and journals. From this review, the editors created an editorial structure specifically for The PHM Core Competencies: 2020 Revision. A new position of Contributing Editor was created to address the need for dedicated attention to the community site perspective and ensure review of all content, within and across chapters, by a pediatric hospitalist who is dedicated to this environment. Solicitation for additional editors and associate editors occurred via the SHM Pediatrics SIG to the wider SHM membership. The criteria for selection included active engagement in regional or national activities related to the growth and operations of PHM, strong organizational and leadership skills, including the ability to manage tasks and foster creativity, among others. In addition, a deliberate effort was made to recruit a diverse editorial cohort, considering geographic location, primary work environment, organizational affiliations, content expertise, time in practice, gender, and other factors.

Chapter Topic Selection

The editors conducted a two-pronged needs assessment related to optimal content for inclusion in The PHM Core Competencies: 2020 Revision. First, the editors reviewed content from conferences, textbooks, and handbooks specific to the field of PHM, including the conference programs for the most recent 5 years of both the annual PHM national conference and annual meetings of PHM’s 3 core societies in the United States—SHM, AAP, and APA. Second, the editors conducted a needs assessment survey with several stakeholder groups, including SHM’s Pediatrics and Medicine-Pediatrics SIGs, AAP Section on Hospital Medicine and its subcommittees, APA Hospital Medicine SIG, PHM Fellowship Directors Council, and PHM Division Directors, with encouragement to pass the survey link to others in the PHM community interested in providing input (Appendix Figure). The solicitation asked for comment on existing chapters and suggestions for new chapters. For any new chapter, respondents were asked to note the intended purpose of the chapter and the anticipated value that chapter would bring to our profession and the children and the caregivers served by pediatric hospitalists.

The entire editorial board then reviewed all of the needs assessment data and considered potential changes (additions or deletions) based on emerging trends in pediatric healthcare, the frequency, relevance, and value of the item across all environments in which pediatric hospitalists function, and the value to or impact on hospitalized children and caregivers. Almost all survey ratings and comments were either incorporated into an existing chapter or used to create a new chapter. There was a paucity of comments related to the deletion of chapters, and thus no chapters were entirely excluded. However, there were several comments supporting the exclusion of the suprapubic bladder tap procedure, and thus related content was eliminated from the relevant section in Core Skills. Of the 66 chapters in this revision, the needs assessment data directly informed the creation of 12 new chapters, as well as adjustments and/or additions to the titles of 7 chapters and the content of 29 chapters. In addition, the title of the Specialized Clinical Services section was changed to Specialized Services to represent that both clinical and nonclinical competencies reside in this section devoted to comprehensive management of these unique patient populations commonly encountered by pediatric hospitalists. Many of these changes are highlighted in Table 2.

Author selection

Authors from the initial work were invited to participate again as author of their given chapter. Subsequently, authors were identified for new chapters and chapters for which previous authors were no longer able to be engaged. Authors with content expertise were found by reviewing content from conferences, textbooks, and handbooks specific to the field of PHM. Any content expert who was not identified as a pediatric hospitalist was paired with a pediatric hospitalist as coauthor. In addition, as with the editorial board, a deliberate effort was made to recruit a diverse author cohort, considering geographic location, primary work environment, time in practice, gender, and other factors.

The editorial board held numerous conference calls to review potential authors, and the SHM Pediatrics SIG was directly engaged to ensure authorship opportunities were extended broadly. This vetting process resulted in a robust author list and included members of all three of PHM’s sponsoring societies in the United States. Once participation was confirmed, authors received an “author packet” detailing the process with the proposed timeline, resources related to writing learning objectives, the past chapter (if applicable), assigned associate editor, and other helpful resources.

Internal and External Review Process

After all chapters were drafted, the editorial board conducted a rigorous, internal review process. Each chapter was reviewed by at least one associate editor and two editors, with a focus on content, scope, and a standard approach to phrasing and formatting. In addition, the contributing editor reviewed all the chapters to ensure the community hospitalist perspective was adequately represented.

Thirty-two agencies and societies were solicited for external review, including both those involved in review of the previous edition and new stakeholder groups. External reviewers were first contacted to ascertain their interest in participating in the review process, and if interested, were provided with information on the review process. Robust feedback was received from the APA Hospital Medicine SIG, SHM Pediatrics and Medicine-Pediatrics SIGs, Association of Pediatric Program Directors Curriculum Committee, and 20 AAP committees, councils, and sections.

The feedback from the external reviewers and subsequent edits for each chapter were reviewed by at least one associate editor, two editors, and the contributing editor. Authors were engaged to address any salient changes recommended. As the final steps in the review process, the SHM Board of Directors approved the compendium and the APA provided their endorsement.

This second edition of The PHM Core Competencies: 2020 Revision addresses the knowledge, skills, attitudes, and systems organization and improvement objectives that define the field of pediatric hospital medicine and the leadership roles of pediatric hospitalists. This compendium reflects the recent changes in the practice and educational environments of pediatric hospitalists and can inform education, training, and career development for pediatric hospitalists across all environments in which comprehensive care is rendered for the hospitalized child. Future work at the local and national level can lead to development of associated curricula, conference content, and other training materials.

Acknowledgments

We wish to humbly and respectfully acknowledge the work of the authors, editors, and reviewers involved in the creation of the first edition, as well as this revision, of The PHM Core Competencies. In addition, we are grateful for the input of all pediatric hospitalists and other stakeholders who informed this compendium via contributions to the needs assessment survey, conference proceedings, publications, and other works. Finally, we acknowledge the support and work of SHM project coordinator, Nyla Nicholson, the SHM Pediatrics SIG, and the SHM Board of Directors.

Disclosures

SHM provided administrative support for project coordination (N. Nicholson). No author, editor, or other involved member received any compensation for efforts related to this work. There are no reported conflicts of interest.

The Pediatric Hospital Medicine Core Competencies were first published in 2010 to help define a specific body of knowledge and measurable skills needed to practice high quality care for hospitalized pediatric patients across all practice settings.¹ Since then, the number of practicing pediatric hospitalists has grown to a conservative estimate of 3,000 physicians and the scope of practice among pediatric hospitalists has matured.² Pediatric hospitalists are increasingly leading or participating in organizational and national efforts that emphasize interprofessional collaboration and the delivery of high value care to hospitalized children and their caregivers—including innovative and family-centered care models, patient safety and quality improvement initiatives, and research and educational enterprises.^3-8 In response to these changes, the American Board of Medical Specialties designated Pediatric Hospital Medicine (PHM) as a pediatric subspecialty in 2016.

The field of PHM in the United States continues to be supported by three core societies—Society of Hospital Medicine (SHM), American Academy of Pediatrics (AAP), and Academic Pediatric Association (APA). Together, these societies serve as tri-sponsors of the annual Pediatric Hospital Medicine national conference, which now welcomes over 1,200 attendees from the United States and abroad.⁹ Each society also individually sponsors a variety of professional development and continuing medical education activities specific to PHM.

In addition, pediatric hospitalists often serve a pivotal role in teaching learners (medical students, residents, and other health profession students), physician colleagues, and other healthcare professionals on the hospital wards and via institutional educational programs. Nearly 50 institutions in the United States offer graduate medical education training in PHM.¹⁰ The PHM Fellowship Directors Council has developed a standardized curricular framework and entrustable professional activities, which reflect the tenets of competency-based medical education, for use in PHM training programs.^11-13

These changes in the practice environment of pediatric hospitalists, as well as the changing landscape of graduate and continuing medical education in PHM, have informed this revision of The PHM Core Competencies. The purpose of this article is to describe the methodology of the review and revision process.

Revision

The PHM Core Competencies: 2020 Revision provide a framework for graduate and continuing medical education that reflects the current roles and expectations for all pediatric hospitalists in the United States. The acuity and complexity of hospitalized children, the availability of pediatric subspecialty care and other resources, and the institutional orientation towards pediatric populations vary across community, tertiary, and children’s hospital settings. In order to unify the practice of PHM across these environments, The PHM Core Competencies: 2020 Revision address the fundamental and most common components of PHM which are encountered by the majority of practicing pediatric hospitalists, as opposed to an extensive review of all aspects of the field.

The compendium includes 66 chapters on both clinical and nonclinical topics, divided into four sections—Common Clinical Diagnoses and Conditions, Core Skills, Specialized Services, and Healthcare Systems: Supporting and Advancing Child Health (Table 1). Within each chapter is an introductory paragraph and learning objectives in three domains of educational outcomes—cognitive (knowledge), psychomotor (skills), and affective (attitudes)—as well as systems organization and improvement, to reflect the emphasis of PHM practice on improving healthcare systems. The objectives encompass a range of observable behaviors and other attributes, from foundational skills such as taking a history and performing a physical exam to more advanced actions such as participating in the development of care models to support the health of complex patient populations. Implicit in these objectives is the expectation that pediatric hospitalists build on experiences in medical school and residency training to attain a level of competency at the advanced levels of a developmental continuum, such as proficient, expert, or master.¹⁴

Project Initiation

Revision of The PHM Core Competencies: 2020 Revision began in early 2017 following SHM’s work on The Core Competencies in Hospital Medicine 2017 Revision.¹⁵ The Executive Committee of the SHM Pediatrics Special Interest Group (SIG) supported the initiation of the revision. The 3 editors from the original compendium created an initial plan for the project that included a proposed timeline, processes for engagement of previously involved experts and new talent, and performance of a needs assessment to guide content selection. The Figure highlights these and other important steps in the revision process.

Editor and Associate Editor Selection

The above editors reviewed best practice examples of roles and responsibilities for editor and associate editor positions from relevant, leading societies and journals. From this review, the editors created an editorial structure specifically for The PHM Core Competencies: 2020 Revision. A new position of Contributing Editor was created to address the need for dedicated attention to the community site perspective and ensure review of all content, within and across chapters, by a pediatric hospitalist who is dedicated to this environment. Solicitation for additional editors and associate editors occurred via the SHM Pediatrics SIG to the wider SHM membership. The criteria for selection included active engagement in regional or national activities related to the growth and operations of PHM, strong organizational and leadership skills, including the ability to manage tasks and foster creativity, among others. In addition, a deliberate effort was made to recruit a diverse editorial cohort, considering geographic location, primary work environment, organizational affiliations, content expertise, time in practice, gender, and other factors.

Chapter Topic Selection

The editors conducted a two-pronged needs assessment related to optimal content for inclusion in The PHM Core Competencies: 2020 Revision. First, the editors reviewed content from conferences, textbooks, and handbooks specific to the field of PHM, including the conference programs for the most recent 5 years of both the annual PHM national conference and annual meetings of PHM’s 3 core societies in the United States—SHM, AAP, and APA. Second, the editors conducted a needs assessment survey with several stakeholder groups, including SHM’s Pediatrics and Medicine-Pediatrics SIGs, AAP Section on Hospital Medicine and its subcommittees, APA Hospital Medicine SIG, PHM Fellowship Directors Council, and PHM Division Directors, with encouragement to pass the survey link to others in the PHM community interested in providing input (Appendix Figure). The solicitation asked for comment on existing chapters and suggestions for new chapters. For any new chapter, respondents were asked to note the intended purpose of the chapter and the anticipated value that chapter would bring to our profession and the children and the caregivers served by pediatric hospitalists.

The entire editorial board then reviewed all of the needs assessment data and considered potential changes (additions or deletions) based on emerging trends in pediatric healthcare, the frequency, relevance, and value of the item across all environments in which pediatric hospitalists function, and the value to or impact on hospitalized children and caregivers. Almost all survey ratings and comments were either incorporated into an existing chapter or used to create a new chapter. There was a paucity of comments related to the deletion of chapters, and thus no chapters were entirely excluded. However, there were several comments supporting the exclusion of the suprapubic bladder tap procedure, and thus related content was eliminated from the relevant section in Core Skills. Of the 66 chapters in this revision, the needs assessment data directly informed the creation of 12 new chapters, as well as adjustments and/or additions to the titles of 7 chapters and the content of 29 chapters. In addition, the title of the Specialized Clinical Services section was changed to Specialized Services to represent that both clinical and nonclinical competencies reside in this section devoted to comprehensive management of these unique patient populations commonly encountered by pediatric hospitalists. Many of these changes are highlighted in Table 2.

Author selection

Authors from the initial work were invited to participate again as author of their given chapter. Subsequently, authors were identified for new chapters and chapters for which previous authors were no longer able to be engaged. Authors with content expertise were found by reviewing content from conferences, textbooks, and handbooks specific to the field of PHM. Any content expert who was not identified as a pediatric hospitalist was paired with a pediatric hospitalist as coauthor. In addition, as with the editorial board, a deliberate effort was made to recruit a diverse author cohort, considering geographic location, primary work environment, time in practice, gender, and other factors.

The editorial board held numerous conference calls to review potential authors, and the SHM Pediatrics SIG was directly engaged to ensure authorship opportunities were extended broadly. This vetting process resulted in a robust author list and included members of all three of PHM’s sponsoring societies in the United States. Once participation was confirmed, authors received an “author packet” detailing the process with the proposed timeline, resources related to writing learning objectives, the past chapter (if applicable), assigned associate editor, and other helpful resources.

Internal and External Review Process

After all chapters were drafted, the editorial board conducted a rigorous, internal review process. Each chapter was reviewed by at least one associate editor and two editors, with a focus on content, scope, and a standard approach to phrasing and formatting. In addition, the contributing editor reviewed all the chapters to ensure the community hospitalist perspective was adequately represented.

Thirty-two agencies and societies were solicited for external review, including both those involved in review of the previous edition and new stakeholder groups. External reviewers were first contacted to ascertain their interest in participating in the review process, and if interested, were provided with information on the review process. Robust feedback was received from the APA Hospital Medicine SIG, SHM Pediatrics and Medicine-Pediatrics SIGs, Association of Pediatric Program Directors Curriculum Committee, and 20 AAP committees, councils, and sections.

The feedback from the external reviewers and subsequent edits for each chapter were reviewed by at least one associate editor, two editors, and the contributing editor. Authors were engaged to address any salient changes recommended. As the final steps in the review process, the SHM Board of Directors approved the compendium and the APA provided their endorsement.

This second edition of The PHM Core Competencies: 2020 Revision addresses the knowledge, skills, attitudes, and systems organization and improvement objectives that define the field of pediatric hospital medicine and the leadership roles of pediatric hospitalists. This compendium reflects the recent changes in the practice and educational environments of pediatric hospitalists and can inform education, training, and career development for pediatric hospitalists across all environments in which comprehensive care is rendered for the hospitalized child. Future work at the local and national level can lead to development of associated curricula, conference content, and other training materials.

Acknowledgments

We wish to humbly and respectfully acknowledge the work of the authors, editors, and reviewers involved in the creation of the first edition, as well as this revision, of The PHM Core Competencies. In addition, we are grateful for the input of all pediatric hospitalists and other stakeholders who informed this compendium via contributions to the needs assessment survey, conference proceedings, publications, and other works. Finally, we acknowledge the support and work of SHM project coordinator, Nyla Nicholson, the SHM Pediatrics SIG, and the SHM Board of Directors.

Disclosures

SHM provided administrative support for project coordination (N. Nicholson). No author, editor, or other involved member received any compensation for efforts related to this work. There are no reported conflicts of interest.

When results in a series of robotic-assisted total knee arthroplasties (TKA) were compared with a series of arthroplasties performed manually by the same surgeon, results were comparable even though the robotic procedures included a learning phase. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“Robotics appears to level the playing field for those who are less experienced, so that robotic total knee arthroplasty might be particularly well suited to low-volume surgeons,” reported Sridhar R. Rachala, MD, assistant professor of orthopaedic surgery, University of Buffalo (N.Y.).

In this retrospective cohort study, radiographic and clinical outcomes were evaluated in 164 total knee arthroplasties performed manually over an 8-month period and compared with 300 procedures performed robotically by the same experienced surgeon over the subsequent 15-month period.

There were no significant differences between patient groups for mean age or body mass index. Dr. Rachala, who performed both sets of procedures, reported inherent differences in technique. Specifically, the mechanical alignment was planned for a traditional neutral mechanical axis, while the robotic procedures were planned in kinematic alignment.

When evaluated at 1 year, the mean KOOS JR (Knee Injury and Osteoarthritis Outcome for Joint Replacement) scores were not significantly different for the robotic and manually performed procedures (76.0 vs. 73.9; P = .54). There were also no differences in the final extension (P = .64) or flexion (P = .59).

However, the difference in mean length of stay (2.0 vs. 2.4 days; P = .0002) favored the robotic approach, and the higher proportion of patients discharged to home after robotic surgery (73% vs. 66%; P = .11) suggested a favorable trend. Planned and postoperative alignment was within two degrees for both groups and not significantly different.

“The robotic series were at a disadvantage because it included cases that I performed when first switching to this approach,” reported Dr. Rachala in an interview.

Although a growing number of total hip arthroplasties are performed robotically, there have not so far been many comparisons of clinical outcomes among surgeons experienced with both approaches, according to Dr. Rachala. Acknowledging that a single-surgeon experience could be considered a limitation of this series, Dr. Rachala also considers it a potential strength. Dr. Rachala was highly experienced with manually instrumented total knee arthroplasty when he switched.

“Positioning and alignment are not just more accurate but easier to perform with robotic assistance,” he said, explaining why this approach is likely to offer a particular advantage to surgeons who perform these types of arthroplasties at low volume. He noted that robotic programming helps prevent errors and adopt alternative more personalized alignments.

Although Dr. Rachala acknowledged that long-term and controlled studies are needed, his experience suggests that robotic-assisted procedures are emerging as a viable alternative with advantages for the surgeon as well as the patient.

The principle that robotic assistance can add consistency to total joint arthroplasty is valid, according to Gwo-Chin Lee, MD, an associate professor of orthopaedic surgery, University of Pennsylvania, Philadelphia. “Robotic-assisted arthroplasty improves the accuracy and consistency of the procedure, which can potentially reduce the likelihood of failure. In knees, it is proven to be valuable in unicompartmental replacements in which results are correlated to a surgeon’s surgical volume. It has an equalizing effect relative to a surgeon with more extensive experience,” Dr. Lee said.

The senior author of a recent systematic review and meta-analysis of robotic-assisted unicompartmental knee arthroplasty (J Knee Surg. 2020 Jan 30; doi: 10.1055/s-0040-1701455), Dr. Lee said, “While the impact of robotics on other metrics including patient satisfaction and early recovery continues to be debated among surgeons who specialize in total knee arthroplasties, the technology can aid surgeons in component position, sizing, and ligament balance, particularly for the lower-volume surgeons and ultimately lead to more predictable outcomes.”

Dr. Rachala reports a financial relationship with Avanos and Stryker.

SOURCE: Rachala S et al. AAOS 2020. Abstract P0091.

When results in a series of robotic-assisted total knee arthroplasties (TKA) were compared with a series of arthroplasties performed manually by the same surgeon, results were comparable even though the robotic procedures included a learning phase. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“Robotics appears to level the playing field for those who are less experienced, so that robotic total knee arthroplasty might be particularly well suited to low-volume surgeons,” reported Sridhar R. Rachala, MD, assistant professor of orthopaedic surgery, University of Buffalo (N.Y.).

In this retrospective cohort study, radiographic and clinical outcomes were evaluated in 164 total knee arthroplasties performed manually over an 8-month period and compared with 300 procedures performed robotically by the same experienced surgeon over the subsequent 15-month period.

There were no significant differences between patient groups for mean age or body mass index. Dr. Rachala, who performed both sets of procedures, reported inherent differences in technique. Specifically, the mechanical alignment was planned for a traditional neutral mechanical axis, while the robotic procedures were planned in kinematic alignment.

When evaluated at 1 year, the mean KOOS JR (Knee Injury and Osteoarthritis Outcome for Joint Replacement) scores were not significantly different for the robotic and manually performed procedures (76.0 vs. 73.9; P = .54). There were also no differences in the final extension (P = .64) or flexion (P = .59).

However, the difference in mean length of stay (2.0 vs. 2.4 days; P = .0002) favored the robotic approach, and the higher proportion of patients discharged to home after robotic surgery (73% vs. 66%; P = .11) suggested a favorable trend. Planned and postoperative alignment was within two degrees for both groups and not significantly different.

“The robotic series were at a disadvantage because it included cases that I performed when first switching to this approach,” reported Dr. Rachala in an interview.

Although a growing number of total hip arthroplasties are performed robotically, there have not so far been many comparisons of clinical outcomes among surgeons experienced with both approaches, according to Dr. Rachala. Acknowledging that a single-surgeon experience could be considered a limitation of this series, Dr. Rachala also considers it a potential strength. Dr. Rachala was highly experienced with manually instrumented total knee arthroplasty when he switched.

“Positioning and alignment are not just more accurate but easier to perform with robotic assistance,” he said, explaining why this approach is likely to offer a particular advantage to surgeons who perform these types of arthroplasties at low volume. He noted that robotic programming helps prevent errors and adopt alternative more personalized alignments.

Although Dr. Rachala acknowledged that long-term and controlled studies are needed, his experience suggests that robotic-assisted procedures are emerging as a viable alternative with advantages for the surgeon as well as the patient.

The principle that robotic assistance can add consistency to total joint arthroplasty is valid, according to Gwo-Chin Lee, MD, an associate professor of orthopaedic surgery, University of Pennsylvania, Philadelphia. “Robotic-assisted arthroplasty improves the accuracy and consistency of the procedure, which can potentially reduce the likelihood of failure. In knees, it is proven to be valuable in unicompartmental replacements in which results are correlated to a surgeon’s surgical volume. It has an equalizing effect relative to a surgeon with more extensive experience,” Dr. Lee said.

The senior author of a recent systematic review and meta-analysis of robotic-assisted unicompartmental knee arthroplasty (J Knee Surg. 2020 Jan 30; doi: 10.1055/s-0040-1701455), Dr. Lee said, “While the impact of robotics on other metrics including patient satisfaction and early recovery continues to be debated among surgeons who specialize in total knee arthroplasties, the technology can aid surgeons in component position, sizing, and ligament balance, particularly for the lower-volume surgeons and ultimately lead to more predictable outcomes.”

Dr. Rachala reports a financial relationship with Avanos and Stryker.

SOURCE: Rachala S et al. AAOS 2020. Abstract P0091.

When results in a series of robotic-assisted total knee arthroplasties (TKA) were compared with a series of arthroplasties performed manually by the same surgeon, results were comparable even though the robotic procedures included a learning phase. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“Robotics appears to level the playing field for those who are less experienced, so that robotic total knee arthroplasty might be particularly well suited to low-volume surgeons,” reported Sridhar R. Rachala, MD, assistant professor of orthopaedic surgery, University of Buffalo (N.Y.).

In this retrospective cohort study, radiographic and clinical outcomes were evaluated in 164 total knee arthroplasties performed manually over an 8-month period and compared with 300 procedures performed robotically by the same experienced surgeon over the subsequent 15-month period.

There were no significant differences between patient groups for mean age or body mass index. Dr. Rachala, who performed both sets of procedures, reported inherent differences in technique. Specifically, the mechanical alignment was planned for a traditional neutral mechanical axis, while the robotic procedures were planned in kinematic alignment.

When evaluated at 1 year, the mean KOOS JR (Knee Injury and Osteoarthritis Outcome for Joint Replacement) scores were not significantly different for the robotic and manually performed procedures (76.0 vs. 73.9; P = .54). There were also no differences in the final extension (P = .64) or flexion (P = .59).

However, the difference in mean length of stay (2.0 vs. 2.4 days; P = .0002) favored the robotic approach, and the higher proportion of patients discharged to home after robotic surgery (73% vs. 66%; P = .11) suggested a favorable trend. Planned and postoperative alignment was within two degrees for both groups and not significantly different.

“The robotic series were at a disadvantage because it included cases that I performed when first switching to this approach,” reported Dr. Rachala in an interview.

Although a growing number of total hip arthroplasties are performed robotically, there have not so far been many comparisons of clinical outcomes among surgeons experienced with both approaches, according to Dr. Rachala. Acknowledging that a single-surgeon experience could be considered a limitation of this series, Dr. Rachala also considers it a potential strength. Dr. Rachala was highly experienced with manually instrumented total knee arthroplasty when he switched.

“Positioning and alignment are not just more accurate but easier to perform with robotic assistance,” he said, explaining why this approach is likely to offer a particular advantage to surgeons who perform these types of arthroplasties at low volume. He noted that robotic programming helps prevent errors and adopt alternative more personalized alignments.

Although Dr. Rachala acknowledged that long-term and controlled studies are needed, his experience suggests that robotic-assisted procedures are emerging as a viable alternative with advantages for the surgeon as well as the patient.

The principle that robotic assistance can add consistency to total joint arthroplasty is valid, according to Gwo-Chin Lee, MD, an associate professor of orthopaedic surgery, University of Pennsylvania, Philadelphia. “Robotic-assisted arthroplasty improves the accuracy and consistency of the procedure, which can potentially reduce the likelihood of failure. In knees, it is proven to be valuable in unicompartmental replacements in which results are correlated to a surgeon’s surgical volume. It has an equalizing effect relative to a surgeon with more extensive experience,” Dr. Lee said.

The senior author of a recent systematic review and meta-analysis of robotic-assisted unicompartmental knee arthroplasty (J Knee Surg. 2020 Jan 30; doi: 10.1055/s-0040-1701455), Dr. Lee said, “While the impact of robotics on other metrics including patient satisfaction and early recovery continues to be debated among surgeons who specialize in total knee arthroplasties, the technology can aid surgeons in component position, sizing, and ligament balance, particularly for the lower-volume surgeons and ultimately lead to more predictable outcomes.”

Dr. Rachala reports a financial relationship with Avanos and Stryker.

SOURCE: Rachala S et al. AAOS 2020. Abstract P0091.

From BJC HealthCare, St. Louis, MO.

Abstract

Background: There is limited literature relating to patient blood management (PBM) programs in large multi-hospital systems or addressing challenges of implementation across diverse systems comprised of community and academic hospitals.

Objective: To establish a PBM program to improve utilization of blood transfusion units at a multi-hospital system in the Midwest (BJC HealthCare).

Methods: High-impact strategies in establishing the PBM program included formation of Clinical Expert Councils (CECs) of providers, establishment of consensus utilization guidelines, and development of a robust reporting tool. CECs enabled collaboration and facilitated standardization across a complex system of academic, private practice, and tertiary facilities with a diverse community of medical providers. Consensus guidelines and the PBM reporting tool were key to creating meaningful reports to drive provider practice change.

Results: Over the 5 years following implementation of the PBM program, there has been a steady decrease in red blood cell (RBC) utilization. Noticeable changes have taken place at individual hospitals in the system, including reductions in transfusions falling outside guideline parameters from 300 per quarter to less than 8 per quarter at 1 of our community hospitals. No negative impact on patient care has been identified.

Conclusion: In response to current transfusion guidelines and the need for optimizing stewardship of blood product resources, this hospital system successfully implemented a robust PBM program that engaged academic and non-academic community providers and decreased utilization of blood transfusion resources in line with consensus guidelines.

Keywords: quality improvement; RBC transfusion; transfusion practices; provider practice change; utilization trends.

Evidence from clinical trials and published clinical guidelines support the adoption of a restrictive blood transfusion approach in hospitalized, stable patients as best practice.^1-5 As such, the development and implementation of patient blood management (PBM) programs has become an increasingly important process improvement for reducing variability in transfusion practices and clinical outcomes.

As recently as 2013, BJC HealthCare, a multi-hospital system in the Midwest, had no standardized, system-wide blood management program, and transfusion practices varied widely across providers and between individual hospitals based on size, patient population, and resources. The system consisted of 13 hospitals, ranging from large tertiary to smaller community and academic hospitals. Although adults constituted the vast majority of the patient population, the hospital system also included a pediatric specialty hospital, St. Louis Children’s Hospital. In addition, some sites were staffed by private practice providers and others by university-based providers, including blood bank medical directors. Due to the diversity of settings and populations, efforts to align transfusion and other practices often faced multiple challenges. However, improving the management of blood transfusions was identified as a key resource stewardship priority in 2013, and implementation of a system-wide program began after extensive discussions and consensus approval by senior hospital system and medical leadership. The primary aim of the program was to optimize overall blood product resource stewardship. Specifically, we sought to control or reduce costs per patient-care episode using strategies that would not negatively impact patient care and could potentially even improve patient outcomes (eg, by avoiding unnecessary transfusions and their attendant risks).

There is a plethora of literature related to the implemention of PBM programs in individual hospitals,^6-18 but few reports specifically relate to large multi-hospital health systems,^19-21 or directly address the unique challenges of implementation across a diverse system of community and academic hospitals and providers.¹⁹ Here, we discuss our experience with establishing a PBM program in a large, diverse, multi-hospital health system, provide examples of innovative strategies, and address challenges faced and lessons learned. Future endeavors of the PBM program at BJC HealthCare are also described.

Setting

BJC HealthCare is one of the largest nonprofit health care organizations in the United States, delivering services to the greater St. Louis, southern Illinois, and mid-Missouri regions, and addressing the health care needs of urban, suburban, and rural communities. As of 2018, the system included 15 hospitals and multiple community health locations comprising more than 3400 staffed beds, 31,500 employees, and 4300 physicians with privileges. The system annually has more than 151,000 hospital admissions, 81,000 outpatient surgery visits, and 537,000 emergency department visits. In addition to inpatient and outpatient care, services include primary care, community health and wellness, workplace health, home health, community mental health, rehabilitation, long-term care, and hospice. As a nonprofit system, BJC is the largest provider of charity care, unreimbursed care, and community benefit in Missouri, highlighting the fact that resource stewardship is a critical issue across the entire system and the communities served.²²

PBM Project

Preparation for large-scale change across several hospitals began with creating a framework for the initiative, which consisted of a “burning platform,” a guiding vision, and a coalition. The burning platform identifies the importance and urgency of a change and helps to establish commitment. Between 2012 and 2014, the American Association of Blood Banks (AABB) released new evidence-based guidelines and recommendations calling for more restrictive transfusion practices pertaining to red blood cells (RBCs; ie, a hemoglobin threshold of 7 to 8 g/dL) in both inpatient and outpatient care.² In addition, use of single-unit transfusions was recognized as best practice by the AABB in the Choosing Wisely campaign.²³ Historically, adult patients requiring transfusions were given 2 units in succession. The new recommendations provided a strong basis for changing transfusion practices at BJC. It was believed that aligning transfusion practices with the new guidelines was consistent with the mission and vision of the work: that these changes could lead to optimization of resources, cost control, reductions in unnecessary blood transfusions, and potentially improved care (eg, fewer transfusion-related complications). We used the national guidelines to initiate discussions and to identify clinical conditions and associated laboratory parameters for transfusion therapy.

Once this burning platform was established, a team comprised of physicians, blood bank experts, quality consultants, data analysts, and supply managers, referred to as the Outcomes Team, was formed to lead the change efforts across the system. Initial projects for the team included developing system-wide consensus-based transfusion guidelines, providing education to providers on the new evidence in transfusion practice, and sharing BJC-specific historical utilization data. The guiding principle for the group was that “blood is a valuable resource, but not without risk, and less is more.” In order to disseminate the vision of the initiative across the system, campaign signs with the slogans “7 is the new 10” (referring to the g/dL transfusion threshold) and “1 is the new 2” (referring to the new practice of the preferential transfusion of single units rather than 2 at a time) were displayed in system hospitals.

Last, a guiding coalition of system leaders was needed to help push the initiative forward and sustain the program once fully implemented. Thus, a multidisciplinary PBM Clinical Expert Counciel (CEC) was formed to assist with implementation and maintenance of the program.

Role of PBM Clinical Expert Council

The PBM CEC was designed to improve overall physician and expert engagement and provide a forum where stakeholders from across the system could participate to voice their expert opinion. CECs (which BJC formed in other clinical areas as well) are multidisciplinary teams consisting of clinical, administrative, and technical staff. The open, multidisciplinary structure of the councils allows for collaboration that promotes change across a complex multi-hospital system. Each hospital is represented by key physicians and technical leaders, opening opportunity for both horizontal and vertical partnership.

As part of the overall physician engagement strategy, the PBM CEC was launched across BJC in November 2013 as a decision-making body for gaining system consensus on matters relating to blood management. The initial goals for the PBM CEC were to share information and educate providers and others on the latest evidence, to subsequently debate and develop consensus for guidelines to be applied across BJC, and to identify and adopt gold standard practices to drive and sustain compliance across the system. More specifically, we wanted to focus on how to avoid unnecessary blood transfusions known to be associated with increased risk for adverse reactions, other morbidity, mortality, and longer length of stay. Council members met quarterly to address 6 key drivers: patient safety, informatics and data, quality improvement, efficiencies and workflows, education and competency, and communication and engagement. Members then voted to approve guidelines, policies, and procedures. The group continues to assist in updating and standardizing guidelines and providing input on improving the functionality of the PBM reporting tool.

Development of the PBM Reporting Tool

Providing and sharing data on blood utilization and practices with the CEC and hospital leaders was imperative to driving change. The Outcomes Team deliberated on how best to generate and provide such information, conducting comparisons between selected vendor-based tools and potential internal BJC solutions. After investigation, BJC leadership approved the development of an in-house PBM dashboard tool using Tableau Desktop (Tableau Software, Inc.). The tool consists of an executive page with 5 additional tabs for navigating to the appropriate information (Figure 1 and Figure 2); data within the tool are organized by facility, service, provider, ICD diagnosis, transfusion indication, and the Clinical Classifications Software category, as defined by the Agency for Healthcare Research and Quality.

The PBM reporting tool was launched on December 31, 2014. The next priority after the launch was to validate the tool’s blood utilization data and implement enhancements to make the tool more effective for users. A super-user group consisting of blood bank supervisors and managers was established. The goals of the user group were to preview any enhancements before presenting the tool to the larger CEC, test and validate data once new information was added, and share and prioritize future enhancements. User group meetings were held monthly to share best practices and discuss individual facilities’ blood utilization data. In addition, each facility’s representative(s) shared how they were driving changes in provider practice and discussed challenges specific to their facility. Enhancements suggested through the user group included: incorporation of additional lab values into the tool to correspond with other blood products (eg, fibrinogen, hematocrit, international normalized ratio, and platelet count), addition of the specific location where the blood product was administered, and standard naming conventions of locations to allow comparisons across facilities (eg, Emergency Department instead of ED, ER, or EU).

All hospital users were given access to a test version of the reporting tool where they could review enhancements, identify what worked well and what could be done better, and suggest corrections. As changes were made to the hospital lab systems, a sample of data was reviewed and validated with affected facilities to confirm the continued accuracy of the data. To ensure its practicality to users, the tool continues to be improved upon with input from council stakeholders and subject-matter experts.

Measurements

To monitor blood utilization across the health system, we tracked the total RBC units administered by hospital, service, and provider and also tracked pre- and post-transfusion hemoglobin values.

Results

Overall, the system has seen a steady decrease in RBC utilization over the 5 years since the PBM program was implemented (Table), with an absolute decrease of 3998 RBC units utilized per year from 2013 to 2018. From this assessment, focus efforts are being identified and future work will incorporate targeted metrics for those areas with higher utilization of RBCs. More importantly, from 2014 through 2017, there was a consistent decreasing trend in the number of transfusion-related safety events (302 to 185, respectively). However, there was a slight increase in reported events from 2018 to 2019 (188 and 266, respectively).

In addition to system-wide improvement, noticeable changes have taken place at individual hospitals in the BJC system. For example, Boone Hospital Center in Columbia, Missouri, began critically reviewing all RBC transfusions starting in 2015 and, to raise awareness, communicating with any provider who transfused a patient outside of transfusion guidelines. Since then, Boone Hospital has seen a dramatic reduction in transfusions considered noncompliant (ie, falling outside guideline parameters), from 300 transfusions per quarter, down to less than 8 per quarter. St. Louis Children’s Hospital also began reviewing blood products utilized by providers that fell outside of the standardized guidelines. At this hospital, physician champions discuss any outliers with the providers involved and use multiple methods for disseminating information to providers, including grand rounds, faculty meetings, and new resident orientations.

Another success has been the partnership between Barnes Jewish St. Peters and Progress West Hospitals in providing PBM education. Their joint effort resulted in implementation of education modules in BJC’s internal learning system, and has provided PBM-related education to more than 367 nurses, blood bank staff, and physicians.

Challenges and Lessons Learned

Implementation of the PBM program was generally successful, but it was not without challenges. One of the biggest challenges was addressing the variation in care and practices across the hospital enterprise. Due to the varying sizes and service goals of individual hospitals, lack of standardization was a significant barrier to change. Gaining trust and buy-in was imperative to increasing compliance with new transfusion policies. The primary concern was finding a balance between respecting physician autonomy and emphasizing and aligning practices with new evidence in the literature. Thus, understanding and applying principles of thoughtful change management was imperative to advancing the framework of the PBM program. The CEC venue enabled collaboration among hospitals and staff and was ultimately used to facilitate the necessary standardization process. To gain the trust of hospital and medical staff, the Outcomes Team conducted several site visits, enabling face-to-face interaction with frontline staff and operational leaders. Moreover, the team’s emphasis on the use of the latest evidence-based guidelines in discussions with hospital and medical staff underscored the need for change.

Frank et al¹⁹ describes using an approach similar to our Outcomes Team at the Johns Hopkins Health System. A designated multidisciplinary quality improvement team, referred to as the “clinical community,” worked on implementing best practices for blood management across a system of 5 hospitals. The authors reported similar results, with an overall decrease in number of units transfused, as well as substantial cost savings.¹⁹ Our project, along with the project implemented by Frank et al, shows how a “consensus-community” approach, involving stakeholders and various experts across the system, can be be used to align practices among multiple hospitals.

Development of a robust PBM reporting tool was key to creating meaningful monthly reports and driving provider practice change. However, this did require several training sessions, site visits, and computer-based training. Members of the Outcomes Team engaged in one-on-one sessions with tool users as a way of addressing specific areas of concern raised by staff at individual blood banks, and also took part in system-wide initiatives. The team also attended blood bank staff meetings and hospital transfusion committee meetings to educate staff on the evidence and initiative, provide demos of the reporting tool, and allow for a more robust discussion of how the data could be used and shared with other departments. These sessions provided opportunities to identify and prioritize future enhancements, as well as opportunities for continued education and discussion at hospitals, which were critical to ongoing improvement of the reporting tool.

Conclusion and Future Directions

Blood products remain extremely valuable and scarce resources, and all health care professionals must work to prevent unnecessary transfusions and improve clinical outcomes by adhering to the latest evidence-based guidelines. In response to current transfusion guidelines and the need to optimize blood product resources, our system successfully implemented a robust PBM program that engaged both academic and non-academic providers and communities. Several elements of the program helped us overcome the challenges relating to standardization of transfusion practices: consensus-based development of guidelines using the latest scientific evidence; formation and utilization of the CEC venue to gain system-wide consensus around both guidelines and approaches to change; development of a trustworthy and accessible PBM reporting tool (as well as continuing education sessions to improve adoption and utilization of the tool); and ongoing multidisciplinary discussions and support of thoughtful change and sustaining activities. We have seen a system-wide decrease in the number of RBC units transfused (absolute and per case mix-adjusted patient day) since implementing the PBM program, and in the following years have noted a trending decrease in transfusion-related safety events. Although there was a slight increase in reported safety events from 2018 to 2019, this was likely due to the systematic implementation of a new electronic medical record system and improved reporting infrastructure.

Upcoming phases of our system-wide PBM program will include looking at opportunities to improve blood utilization in other specific clinical areas. For example, we have begun discussions with hematology and oncology experts across the system to expand their patient population data within the PBM reporting tool, and to identify areas of opportunity for provider practice change within their specialty. We are also reviewing cardiothoracic surgery transfusion data to identify opportunities for reducing blood utilization in specific clinical scenarios. In addition, we are working to incorporate our 2 newest hospital system members (Memorial Hospital East and Memorial Hospital Belleville) into the PBM program. In collaboration with perioperative leaders across the system, the surgical blood ordering process is being reviewed. The goal of this effort is to reduce blood products ordered in preparation for surgical procedures. We are also currently investigating whether an impact on safety events (ie, reduction in transfusion reactions) can yet be detected. Last, our health care system recently launched a system-wide electronic medical record, and we are eager to see how this will provide us with new methods to monitor and analyze blood administration and utilization data. We look forward to reporting on the expansion of our program and on any clinical outcome improvements gained through avoidance of unnecessary transfusions.

Acknowledgment: The authors thank the leadership within the Center for Clinical Excellence and Supply Chain at BJC HealthCare for their support of this manuscript, as well as all system participants who have contributed to these efforts, especially Mohammad Agha, MD, MHA, current physician leader of the PBM CEC, for his thoughtful edits of this manuscript.

Corresponding author: Audrey A. Gronemeyer, MPH, Center for Clinical Excellence, BJC HealthCare, 8300 Eager Road, Suite 400A, St. Louis, MO 63144; [email protected].

Financial disclosures: None.

From BJC HealthCare, St. Louis, MO.

Abstract

Background: There is limited literature relating to patient blood management (PBM) programs in large multi-hospital systems or addressing challenges of implementation across diverse systems comprised of community and academic hospitals.

Objective: To establish a PBM program to improve utilization of blood transfusion units at a multi-hospital system in the Midwest (BJC HealthCare).

Methods: High-impact strategies in establishing the PBM program included formation of Clinical Expert Councils (CECs) of providers, establishment of consensus utilization guidelines, and development of a robust reporting tool. CECs enabled collaboration and facilitated standardization across a complex system of academic, private practice, and tertiary facilities with a diverse community of medical providers. Consensus guidelines and the PBM reporting tool were key to creating meaningful reports to drive provider practice change.

Results: Over the 5 years following implementation of the PBM program, there has been a steady decrease in red blood cell (RBC) utilization. Noticeable changes have taken place at individual hospitals in the system, including reductions in transfusions falling outside guideline parameters from 300 per quarter to less than 8 per quarter at 1 of our community hospitals. No negative impact on patient care has been identified.

Conclusion: In response to current transfusion guidelines and the need for optimizing stewardship of blood product resources, this hospital system successfully implemented a robust PBM program that engaged academic and non-academic community providers and decreased utilization of blood transfusion resources in line with consensus guidelines.

Keywords: quality improvement; RBC transfusion; transfusion practices; provider practice change; utilization trends.

Evidence from clinical trials and published clinical guidelines support the adoption of a restrictive blood transfusion approach in hospitalized, stable patients as best practice.^1-5 As such, the development and implementation of patient blood management (PBM) programs has become an increasingly important process improvement for reducing variability in transfusion practices and clinical outcomes.

As recently as 2013, BJC HealthCare, a multi-hospital system in the Midwest, had no standardized, system-wide blood management program, and transfusion practices varied widely across providers and between individual hospitals based on size, patient population, and resources. The system consisted of 13 hospitals, ranging from large tertiary to smaller community and academic hospitals. Although adults constituted the vast majority of the patient population, the hospital system also included a pediatric specialty hospital, St. Louis Children’s Hospital. In addition, some sites were staffed by private practice providers and others by university-based providers, including blood bank medical directors. Due to the diversity of settings and populations, efforts to align transfusion and other practices often faced multiple challenges. However, improving the management of blood transfusions was identified as a key resource stewardship priority in 2013, and implementation of a system-wide program began after extensive discussions and consensus approval by senior hospital system and medical leadership. The primary aim of the program was to optimize overall blood product resource stewardship. Specifically, we sought to control or reduce costs per patient-care episode using strategies that would not negatively impact patient care and could potentially even improve patient outcomes (eg, by avoiding unnecessary transfusions and their attendant risks).

There is a plethora of literature related to the implemention of PBM programs in individual hospitals,^6-18 but few reports specifically relate to large multi-hospital health systems,^19-21 or directly address the unique challenges of implementation across a diverse system of community and academic hospitals and providers.¹⁹ Here, we discuss our experience with establishing a PBM program in a large, diverse, multi-hospital health system, provide examples of innovative strategies, and address challenges faced and lessons learned. Future endeavors of the PBM program at BJC HealthCare are also described.

Setting

BJC HealthCare is one of the largest nonprofit health care organizations in the United States, delivering services to the greater St. Louis, southern Illinois, and mid-Missouri regions, and addressing the health care needs of urban, suburban, and rural communities. As of 2018, the system included 15 hospitals and multiple community health locations comprising more than 3400 staffed beds, 31,500 employees, and 4300 physicians with privileges. The system annually has more than 151,000 hospital admissions, 81,000 outpatient surgery visits, and 537,000 emergency department visits. In addition to inpatient and outpatient care, services include primary care, community health and wellness, workplace health, home health, community mental health, rehabilitation, long-term care, and hospice. As a nonprofit system, BJC is the largest provider of charity care, unreimbursed care, and community benefit in Missouri, highlighting the fact that resource stewardship is a critical issue across the entire system and the communities served.²²

PBM Project

Preparation for large-scale change across several hospitals began with creating a framework for the initiative, which consisted of a “burning platform,” a guiding vision, and a coalition. The burning platform identifies the importance and urgency of a change and helps to establish commitment. Between 2012 and 2014, the American Association of Blood Banks (AABB) released new evidence-based guidelines and recommendations calling for more restrictive transfusion practices pertaining to red blood cells (RBCs; ie, a hemoglobin threshold of 7 to 8 g/dL) in both inpatient and outpatient care.² In addition, use of single-unit transfusions was recognized as best practice by the AABB in the Choosing Wisely campaign.²³ Historically, adult patients requiring transfusions were given 2 units in succession. The new recommendations provided a strong basis for changing transfusion practices at BJC. It was believed that aligning transfusion practices with the new guidelines was consistent with the mission and vision of the work: that these changes could lead to optimization of resources, cost control, reductions in unnecessary blood transfusions, and potentially improved care (eg, fewer transfusion-related complications). We used the national guidelines to initiate discussions and to identify clinical conditions and associated laboratory parameters for transfusion therapy.

Once this burning platform was established, a team comprised of physicians, blood bank experts, quality consultants, data analysts, and supply managers, referred to as the Outcomes Team, was formed to lead the change efforts across the system. Initial projects for the team included developing system-wide consensus-based transfusion guidelines, providing education to providers on the new evidence in transfusion practice, and sharing BJC-specific historical utilization data. The guiding principle for the group was that “blood is a valuable resource, but not without risk, and less is more.” In order to disseminate the vision of the initiative across the system, campaign signs with the slogans “7 is the new 10” (referring to the g/dL transfusion threshold) and “1 is the new 2” (referring to the new practice of the preferential transfusion of single units rather than 2 at a time) were displayed in system hospitals.

Last, a guiding coalition of system leaders was needed to help push the initiative forward and sustain the program once fully implemented. Thus, a multidisciplinary PBM Clinical Expert Counciel (CEC) was formed to assist with implementation and maintenance of the program.

Role of PBM Clinical Expert Council

The PBM CEC was designed to improve overall physician and expert engagement and provide a forum where stakeholders from across the system could participate to voice their expert opinion. CECs (which BJC formed in other clinical areas as well) are multidisciplinary teams consisting of clinical, administrative, and technical staff. The open, multidisciplinary structure of the councils allows for collaboration that promotes change across a complex multi-hospital system. Each hospital is represented by key physicians and technical leaders, opening opportunity for both horizontal and vertical partnership.

As part of the overall physician engagement strategy, the PBM CEC was launched across BJC in November 2013 as a decision-making body for gaining system consensus on matters relating to blood management. The initial goals for the PBM CEC were to share information and educate providers and others on the latest evidence, to subsequently debate and develop consensus for guidelines to be applied across BJC, and to identify and adopt gold standard practices to drive and sustain compliance across the system. More specifically, we wanted to focus on how to avoid unnecessary blood transfusions known to be associated with increased risk for adverse reactions, other morbidity, mortality, and longer length of stay. Council members met quarterly to address 6 key drivers: patient safety, informatics and data, quality improvement, efficiencies and workflows, education and competency, and communication and engagement. Members then voted to approve guidelines, policies, and procedures. The group continues to assist in updating and standardizing guidelines and providing input on improving the functionality of the PBM reporting tool.

Development of the PBM Reporting Tool

Providing and sharing data on blood utilization and practices with the CEC and hospital leaders was imperative to driving change. The Outcomes Team deliberated on how best to generate and provide such information, conducting comparisons between selected vendor-based tools and potential internal BJC solutions. After investigation, BJC leadership approved the development of an in-house PBM dashboard tool using Tableau Desktop (Tableau Software, Inc.). The tool consists of an executive page with 5 additional tabs for navigating to the appropriate information (Figure 1 and Figure 2); data within the tool are organized by facility, service, provider, ICD diagnosis, transfusion indication, and the Clinical Classifications Software category, as defined by the Agency for Healthcare Research and Quality.

The PBM reporting tool was launched on December 31, 2014. The next priority after the launch was to validate the tool’s blood utilization data and implement enhancements to make the tool more effective for users. A super-user group consisting of blood bank supervisors and managers was established. The goals of the user group were to preview any enhancements before presenting the tool to the larger CEC, test and validate data once new information was added, and share and prioritize future enhancements. User group meetings were held monthly to share best practices and discuss individual facilities’ blood utilization data. In addition, each facility’s representative(s) shared how they were driving changes in provider practice and discussed challenges specific to their facility. Enhancements suggested through the user group included: incorporation of additional lab values into the tool to correspond with other blood products (eg, fibrinogen, hematocrit, international normalized ratio, and platelet count), addition of the specific location where the blood product was administered, and standard naming conventions of locations to allow comparisons across facilities (eg, Emergency Department instead of ED, ER, or EU).

All hospital users were given access to a test version of the reporting tool where they could review enhancements, identify what worked well and what could be done better, and suggest corrections. As changes were made to the hospital lab systems, a sample of data was reviewed and validated with affected facilities to confirm the continued accuracy of the data. To ensure its practicality to users, the tool continues to be improved upon with input from council stakeholders and subject-matter experts.

Measurements

To monitor blood utilization across the health system, we tracked the total RBC units administered by hospital, service, and provider and also tracked pre- and post-transfusion hemoglobin values.

Results

Overall, the system has seen a steady decrease in RBC utilization over the 5 years since the PBM program was implemented (Table), with an absolute decrease of 3998 RBC units utilized per year from 2013 to 2018. From this assessment, focus efforts are being identified and future work will incorporate targeted metrics for those areas with higher utilization of RBCs. More importantly, from 2014 through 2017, there was a consistent decreasing trend in the number of transfusion-related safety events (302 to 185, respectively). However, there was a slight increase in reported events from 2018 to 2019 (188 and 266, respectively).

In addition to system-wide improvement, noticeable changes have taken place at individual hospitals in the BJC system. For example, Boone Hospital Center in Columbia, Missouri, began critically reviewing all RBC transfusions starting in 2015 and, to raise awareness, communicating with any provider who transfused a patient outside of transfusion guidelines. Since then, Boone Hospital has seen a dramatic reduction in transfusions considered noncompliant (ie, falling outside guideline parameters), from 300 transfusions per quarter, down to less than 8 per quarter. St. Louis Children’s Hospital also began reviewing blood products utilized by providers that fell outside of the standardized guidelines. At this hospital, physician champions discuss any outliers with the providers involved and use multiple methods for disseminating information to providers, including grand rounds, faculty meetings, and new resident orientations.

Another success has been the partnership between Barnes Jewish St. Peters and Progress West Hospitals in providing PBM education. Their joint effort resulted in implementation of education modules in BJC’s internal learning system, and has provided PBM-related education to more than 367 nurses, blood bank staff, and physicians.

Challenges and Lessons Learned

Implementation of the PBM program was generally successful, but it was not without challenges. One of the biggest challenges was addressing the variation in care and practices across the hospital enterprise. Due to the varying sizes and service goals of individual hospitals, lack of standardization was a significant barrier to change. Gaining trust and buy-in was imperative to increasing compliance with new transfusion policies. The primary concern was finding a balance between respecting physician autonomy and emphasizing and aligning practices with new evidence in the literature. Thus, understanding and applying principles of thoughtful change management was imperative to advancing the framework of the PBM program. The CEC venue enabled collaboration among hospitals and staff and was ultimately used to facilitate the necessary standardization process. To gain the trust of hospital and medical staff, the Outcomes Team conducted several site visits, enabling face-to-face interaction with frontline staff and operational leaders. Moreover, the team’s emphasis on the use of the latest evidence-based guidelines in discussions with hospital and medical staff underscored the need for change.

Frank et al¹⁹ describes using an approach similar to our Outcomes Team at the Johns Hopkins Health System. A designated multidisciplinary quality improvement team, referred to as the “clinical community,” worked on implementing best practices for blood management across a system of 5 hospitals. The authors reported similar results, with an overall decrease in number of units transfused, as well as substantial cost savings.¹⁹ Our project, along with the project implemented by Frank et al, shows how a “consensus-community” approach, involving stakeholders and various experts across the system, can be be used to align practices among multiple hospitals.

Development of a robust PBM reporting tool was key to creating meaningful monthly reports and driving provider practice change. However, this did require several training sessions, site visits, and computer-based training. Members of the Outcomes Team engaged in one-on-one sessions with tool users as a way of addressing specific areas of concern raised by staff at individual blood banks, and also took part in system-wide initiatives. The team also attended blood bank staff meetings and hospital transfusion committee meetings to educate staff on the evidence and initiative, provide demos of the reporting tool, and allow for a more robust discussion of how the data could be used and shared with other departments. These sessions provided opportunities to identify and prioritize future enhancements, as well as opportunities for continued education and discussion at hospitals, which were critical to ongoing improvement of the reporting tool.

Conclusion and Future Directions

Blood products remain extremely valuable and scarce resources, and all health care professionals must work to prevent unnecessary transfusions and improve clinical outcomes by adhering to the latest evidence-based guidelines. In response to current transfusion guidelines and the need to optimize blood product resources, our system successfully implemented a robust PBM program that engaged both academic and non-academic providers and communities. Several elements of the program helped us overcome the challenges relating to standardization of transfusion practices: consensus-based development of guidelines using the latest scientific evidence; formation and utilization of the CEC venue to gain system-wide consensus around both guidelines and approaches to change; development of a trustworthy and accessible PBM reporting tool (as well as continuing education sessions to improve adoption and utilization of the tool); and ongoing multidisciplinary discussions and support of thoughtful change and sustaining activities. We have seen a system-wide decrease in the number of RBC units transfused (absolute and per case mix-adjusted patient day) since implementing the PBM program, and in the following years have noted a trending decrease in transfusion-related safety events. Although there was a slight increase in reported safety events from 2018 to 2019, this was likely due to the systematic implementation of a new electronic medical record system and improved reporting infrastructure.

Upcoming phases of our system-wide PBM program will include looking at opportunities to improve blood utilization in other specific clinical areas. For example, we have begun discussions with hematology and oncology experts across the system to expand their patient population data within the PBM reporting tool, and to identify areas of opportunity for provider practice change within their specialty. We are also reviewing cardiothoracic surgery transfusion data to identify opportunities for reducing blood utilization in specific clinical scenarios. In addition, we are working to incorporate our 2 newest hospital system members (Memorial Hospital East and Memorial Hospital Belleville) into the PBM program. In collaboration with perioperative leaders across the system, the surgical blood ordering process is being reviewed. The goal of this effort is to reduce blood products ordered in preparation for surgical procedures. We are also currently investigating whether an impact on safety events (ie, reduction in transfusion reactions) can yet be detected. Last, our health care system recently launched a system-wide electronic medical record, and we are eager to see how this will provide us with new methods to monitor and analyze blood administration and utilization data. We look forward to reporting on the expansion of our program and on any clinical outcome improvements gained through avoidance of unnecessary transfusions.

Acknowledgment: The authors thank the leadership within the Center for Clinical Excellence and Supply Chain at BJC HealthCare for their support of this manuscript, as well as all system participants who have contributed to these efforts, especially Mohammad Agha, MD, MHA, current physician leader of the PBM CEC, for his thoughtful edits of this manuscript.

Corresponding author: Audrey A. Gronemeyer, MPH, Center for Clinical Excellence, BJC HealthCare, 8300 Eager Road, Suite 400A, St. Louis, MO 63144; [email protected].

Financial disclosures: None.

From BJC HealthCare, St. Louis, MO.

Abstract

Background: There is limited literature relating to patient blood management (PBM) programs in large multi-hospital systems or addressing challenges of implementation across diverse systems comprised of community and academic hospitals.

Objective: To establish a PBM program to improve utilization of blood transfusion units at a multi-hospital system in the Midwest (BJC HealthCare).

Methods: High-impact strategies in establishing the PBM program included formation of Clinical Expert Councils (CECs) of providers, establishment of consensus utilization guidelines, and development of a robust reporting tool. CECs enabled collaboration and facilitated standardization across a complex system of academic, private practice, and tertiary facilities with a diverse community of medical providers. Consensus guidelines and the PBM reporting tool were key to creating meaningful reports to drive provider practice change.

Results: Over the 5 years following implementation of the PBM program, there has been a steady decrease in red blood cell (RBC) utilization. Noticeable changes have taken place at individual hospitals in the system, including reductions in transfusions falling outside guideline parameters from 300 per quarter to less than 8 per quarter at 1 of our community hospitals. No negative impact on patient care has been identified.

Conclusion: In response to current transfusion guidelines and the need for optimizing stewardship of blood product resources, this hospital system successfully implemented a robust PBM program that engaged academic and non-academic community providers and decreased utilization of blood transfusion resources in line with consensus guidelines.

Keywords: quality improvement; RBC transfusion; transfusion practices; provider practice change; utilization trends.

Evidence from clinical trials and published clinical guidelines support the adoption of a restrictive blood transfusion approach in hospitalized, stable patients as best practice.^1-5 As such, the development and implementation of patient blood management (PBM) programs has become an increasingly important process improvement for reducing variability in transfusion practices and clinical outcomes.

As recently as 2013, BJC HealthCare, a multi-hospital system in the Midwest, had no standardized, system-wide blood management program, and transfusion practices varied widely across providers and between individual hospitals based on size, patient population, and resources. The system consisted of 13 hospitals, ranging from large tertiary to smaller community and academic hospitals. Although adults constituted the vast majority of the patient population, the hospital system also included a pediatric specialty hospital, St. Louis Children’s Hospital. In addition, some sites were staffed by private practice providers and others by university-based providers, including blood bank medical directors. Due to the diversity of settings and populations, efforts to align transfusion and other practices often faced multiple challenges. However, improving the management of blood transfusions was identified as a key resource stewardship priority in 2013, and implementation of a system-wide program began after extensive discussions and consensus approval by senior hospital system and medical leadership. The primary aim of the program was to optimize overall blood product resource stewardship. Specifically, we sought to control or reduce costs per patient-care episode using strategies that would not negatively impact patient care and could potentially even improve patient outcomes (eg, by avoiding unnecessary transfusions and their attendant risks).

There is a plethora of literature related to the implemention of PBM programs in individual hospitals,^6-18 but few reports specifically relate to large multi-hospital health systems,^19-21 or directly address the unique challenges of implementation across a diverse system of community and academic hospitals and providers.¹⁹ Here, we discuss our experience with establishing a PBM program in a large, diverse, multi-hospital health system, provide examples of innovative strategies, and address challenges faced and lessons learned. Future endeavors of the PBM program at BJC HealthCare are also described.

Setting

BJC HealthCare is one of the largest nonprofit health care organizations in the United States, delivering services to the greater St. Louis, southern Illinois, and mid-Missouri regions, and addressing the health care needs of urban, suburban, and rural communities. As of 2018, the system included 15 hospitals and multiple community health locations comprising more than 3400 staffed beds, 31,500 employees, and 4300 physicians with privileges. The system annually has more than 151,000 hospital admissions, 81,000 outpatient surgery visits, and 537,000 emergency department visits. In addition to inpatient and outpatient care, services include primary care, community health and wellness, workplace health, home health, community mental health, rehabilitation, long-term care, and hospice. As a nonprofit system, BJC is the largest provider of charity care, unreimbursed care, and community benefit in Missouri, highlighting the fact that resource stewardship is a critical issue across the entire system and the communities served.²²

PBM Project

Preparation for large-scale change across several hospitals began with creating a framework for the initiative, which consisted of a “burning platform,” a guiding vision, and a coalition. The burning platform identifies the importance and urgency of a change and helps to establish commitment. Between 2012 and 2014, the American Association of Blood Banks (AABB) released new evidence-based guidelines and recommendations calling for more restrictive transfusion practices pertaining to red blood cells (RBCs; ie, a hemoglobin threshold of 7 to 8 g/dL) in both inpatient and outpatient care.² In addition, use of single-unit transfusions was recognized as best practice by the AABB in the Choosing Wisely campaign.²³ Historically, adult patients requiring transfusions were given 2 units in succession. The new recommendations provided a strong basis for changing transfusion practices at BJC. It was believed that aligning transfusion practices with the new guidelines was consistent with the mission and vision of the work: that these changes could lead to optimization of resources, cost control, reductions in unnecessary blood transfusions, and potentially improved care (eg, fewer transfusion-related complications). We used the national guidelines to initiate discussions and to identify clinical conditions and associated laboratory parameters for transfusion therapy.

Once this burning platform was established, a team comprised of physicians, blood bank experts, quality consultants, data analysts, and supply managers, referred to as the Outcomes Team, was formed to lead the change efforts across the system. Initial projects for the team included developing system-wide consensus-based transfusion guidelines, providing education to providers on the new evidence in transfusion practice, and sharing BJC-specific historical utilization data. The guiding principle for the group was that “blood is a valuable resource, but not without risk, and less is more.” In order to disseminate the vision of the initiative across the system, campaign signs with the slogans “7 is the new 10” (referring to the g/dL transfusion threshold) and “1 is the new 2” (referring to the new practice of the preferential transfusion of single units rather than 2 at a time) were displayed in system hospitals.

Last, a guiding coalition of system leaders was needed to help push the initiative forward and sustain the program once fully implemented. Thus, a multidisciplinary PBM Clinical Expert Counciel (CEC) was formed to assist with implementation and maintenance of the program.

Role of PBM Clinical Expert Council

The PBM CEC was designed to improve overall physician and expert engagement and provide a forum where stakeholders from across the system could participate to voice their expert opinion. CECs (which BJC formed in other clinical areas as well) are multidisciplinary teams consisting of clinical, administrative, and technical staff. The open, multidisciplinary structure of the councils allows for collaboration that promotes change across a complex multi-hospital system. Each hospital is represented by key physicians and technical leaders, opening opportunity for both horizontal and vertical partnership.

As part of the overall physician engagement strategy, the PBM CEC was launched across BJC in November 2013 as a decision-making body for gaining system consensus on matters relating to blood management. The initial goals for the PBM CEC were to share information and educate providers and others on the latest evidence, to subsequently debate and develop consensus for guidelines to be applied across BJC, and to identify and adopt gold standard practices to drive and sustain compliance across the system. More specifically, we wanted to focus on how to avoid unnecessary blood transfusions known to be associated with increased risk for adverse reactions, other morbidity, mortality, and longer length of stay. Council members met quarterly to address 6 key drivers: patient safety, informatics and data, quality improvement, efficiencies and workflows, education and competency, and communication and engagement. Members then voted to approve guidelines, policies, and procedures. The group continues to assist in updating and standardizing guidelines and providing input on improving the functionality of the PBM reporting tool.

Development of the PBM Reporting Tool

Providing and sharing data on blood utilization and practices with the CEC and hospital leaders was imperative to driving change. The Outcomes Team deliberated on how best to generate and provide such information, conducting comparisons between selected vendor-based tools and potential internal BJC solutions. After investigation, BJC leadership approved the development of an in-house PBM dashboard tool using Tableau Desktop (Tableau Software, Inc.). The tool consists of an executive page with 5 additional tabs for navigating to the appropriate information (Figure 1 and Figure 2); data within the tool are organized by facility, service, provider, ICD diagnosis, transfusion indication, and the Clinical Classifications Software category, as defined by the Agency for Healthcare Research and Quality.

The PBM reporting tool was launched on December 31, 2014. The next priority after the launch was to validate the tool’s blood utilization data and implement enhancements to make the tool more effective for users. A super-user group consisting of blood bank supervisors and managers was established. The goals of the user group were to preview any enhancements before presenting the tool to the larger CEC, test and validate data once new information was added, and share and prioritize future enhancements. User group meetings were held monthly to share best practices and discuss individual facilities’ blood utilization data. In addition, each facility’s representative(s) shared how they were driving changes in provider practice and discussed challenges specific to their facility. Enhancements suggested through the user group included: incorporation of additional lab values into the tool to correspond with other blood products (eg, fibrinogen, hematocrit, international normalized ratio, and platelet count), addition of the specific location where the blood product was administered, and standard naming conventions of locations to allow comparisons across facilities (eg, Emergency Department instead of ED, ER, or EU).

All hospital users were given access to a test version of the reporting tool where they could review enhancements, identify what worked well and what could be done better, and suggest corrections. As changes were made to the hospital lab systems, a sample of data was reviewed and validated with affected facilities to confirm the continued accuracy of the data. To ensure its practicality to users, the tool continues to be improved upon with input from council stakeholders and subject-matter experts.

Measurements

To monitor blood utilization across the health system, we tracked the total RBC units administered by hospital, service, and provider and also tracked pre- and post-transfusion hemoglobin values.

Results

Overall, the system has seen a steady decrease in RBC utilization over the 5 years since the PBM program was implemented (Table), with an absolute decrease of 3998 RBC units utilized per year from 2013 to 2018. From this assessment, focus efforts are being identified and future work will incorporate targeted metrics for those areas with higher utilization of RBCs. More importantly, from 2014 through 2017, there was a consistent decreasing trend in the number of transfusion-related safety events (302 to 185, respectively). However, there was a slight increase in reported events from 2018 to 2019 (188 and 266, respectively).

In addition to system-wide improvement, noticeable changes have taken place at individual hospitals in the BJC system. For example, Boone Hospital Center in Columbia, Missouri, began critically reviewing all RBC transfusions starting in 2015 and, to raise awareness, communicating with any provider who transfused a patient outside of transfusion guidelines. Since then, Boone Hospital has seen a dramatic reduction in transfusions considered noncompliant (ie, falling outside guideline parameters), from 300 transfusions per quarter, down to less than 8 per quarter. St. Louis Children’s Hospital also began reviewing blood products utilized by providers that fell outside of the standardized guidelines. At this hospital, physician champions discuss any outliers with the providers involved and use multiple methods for disseminating information to providers, including grand rounds, faculty meetings, and new resident orientations.

Another success has been the partnership between Barnes Jewish St. Peters and Progress West Hospitals in providing PBM education. Their joint effort resulted in implementation of education modules in BJC’s internal learning system, and has provided PBM-related education to more than 367 nurses, blood bank staff, and physicians.

Challenges and Lessons Learned

Implementation of the PBM program was generally successful, but it was not without challenges. One of the biggest challenges was addressing the variation in care and practices across the hospital enterprise. Due to the varying sizes and service goals of individual hospitals, lack of standardization was a significant barrier to change. Gaining trust and buy-in was imperative to increasing compliance with new transfusion policies. The primary concern was finding a balance between respecting physician autonomy and emphasizing and aligning practices with new evidence in the literature. Thus, understanding and applying principles of thoughtful change management was imperative to advancing the framework of the PBM program. The CEC venue enabled collaboration among hospitals and staff and was ultimately used to facilitate the necessary standardization process. To gain the trust of hospital and medical staff, the Outcomes Team conducted several site visits, enabling face-to-face interaction with frontline staff and operational leaders. Moreover, the team’s emphasis on the use of the latest evidence-based guidelines in discussions with hospital and medical staff underscored the need for change.

Frank et al¹⁹ describes using an approach similar to our Outcomes Team at the Johns Hopkins Health System. A designated multidisciplinary quality improvement team, referred to as the “clinical community,” worked on implementing best practices for blood management across a system of 5 hospitals. The authors reported similar results, with an overall decrease in number of units transfused, as well as substantial cost savings.¹⁹ Our project, along with the project implemented by Frank et al, shows how a “consensus-community” approach, involving stakeholders and various experts across the system, can be be used to align practices among multiple hospitals.

Development of a robust PBM reporting tool was key to creating meaningful monthly reports and driving provider practice change. However, this did require several training sessions, site visits, and computer-based training. Members of the Outcomes Team engaged in one-on-one sessions with tool users as a way of addressing specific areas of concern raised by staff at individual blood banks, and also took part in system-wide initiatives. The team also attended blood bank staff meetings and hospital transfusion committee meetings to educate staff on the evidence and initiative, provide demos of the reporting tool, and allow for a more robust discussion of how the data could be used and shared with other departments. These sessions provided opportunities to identify and prioritize future enhancements, as well as opportunities for continued education and discussion at hospitals, which were critical to ongoing improvement of the reporting tool.

Conclusion and Future Directions

Blood products remain extremely valuable and scarce resources, and all health care professionals must work to prevent unnecessary transfusions and improve clinical outcomes by adhering to the latest evidence-based guidelines. In response to current transfusion guidelines and the need to optimize blood product resources, our system successfully implemented a robust PBM program that engaged both academic and non-academic providers and communities. Several elements of the program helped us overcome the challenges relating to standardization of transfusion practices: consensus-based development of guidelines using the latest scientific evidence; formation and utilization of the CEC venue to gain system-wide consensus around both guidelines and approaches to change; development of a trustworthy and accessible PBM reporting tool (as well as continuing education sessions to improve adoption and utilization of the tool); and ongoing multidisciplinary discussions and support of thoughtful change and sustaining activities. We have seen a system-wide decrease in the number of RBC units transfused (absolute and per case mix-adjusted patient day) since implementing the PBM program, and in the following years have noted a trending decrease in transfusion-related safety events. Although there was a slight increase in reported safety events from 2018 to 2019, this was likely due to the systematic implementation of a new electronic medical record system and improved reporting infrastructure.

Upcoming phases of our system-wide PBM program will include looking at opportunities to improve blood utilization in other specific clinical areas. For example, we have begun discussions with hematology and oncology experts across the system to expand their patient population data within the PBM reporting tool, and to identify areas of opportunity for provider practice change within their specialty. We are also reviewing cardiothoracic surgery transfusion data to identify opportunities for reducing blood utilization in specific clinical scenarios. In addition, we are working to incorporate our 2 newest hospital system members (Memorial Hospital East and Memorial Hospital Belleville) into the PBM program. In collaboration with perioperative leaders across the system, the surgical blood ordering process is being reviewed. The goal of this effort is to reduce blood products ordered in preparation for surgical procedures. We are also currently investigating whether an impact on safety events (ie, reduction in transfusion reactions) can yet be detected. Last, our health care system recently launched a system-wide electronic medical record, and we are eager to see how this will provide us with new methods to monitor and analyze blood administration and utilization data. We look forward to reporting on the expansion of our program and on any clinical outcome improvements gained through avoidance of unnecessary transfusions.

Acknowledgment: The authors thank the leadership within the Center for Clinical Excellence and Supply Chain at BJC HealthCare for their support of this manuscript, as well as all system participants who have contributed to these efforts, especially Mohammad Agha, MD, MHA, current physician leader of the PBM CEC, for his thoughtful edits of this manuscript.

Corresponding author: Audrey A. Gronemeyer, MPH, Center for Clinical Excellence, BJC HealthCare, 8300 Eager Road, Suite 400A, St. Louis, MO 63144; [email protected].

Financial disclosures: None.

From the Department of Medicine, University of California, Irvine, Orange, CA.

Abstract

Background: Orange County’s residents have difficulty accessing timely, quality, affordable specialty care services. As the county’s only academic health system, the University of California, Irvine (UCI) aimed to improve specialty care access for the communities it serves by implementing an electronic consultations (eConsults) program that allows primary care providers (PCPs) to efficiently receive specialist recommendations on referral problems that do not require an in-person evaluation.

Objective: To implement an eConsults program at the UCI that enhances access to and the delivery of coordinated specialty care for lower-complexity referral problems.

Methods: We developed custom solutions to integrate eConsults into UCI’s 2 electronic health record platforms. The impact of the eConsults program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of submitted eConsult requests per PCP, the number of completed responses per specialty, and the response time for eConsult requests. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback.

Results: Over 4.5 years, more than 1400 successful eConsults have been completed, and the program has expanded to 17 specialties. The average turnaround time for an eConsult response across all specialties was 1 business day. Moreover, more than 50% of the eConsults received specialty responses within the same day of the eConsult request. Most important, about 80% of eConsult requests were addressed without the need for an in-office visit with a specialist.

Conclusion: The enhanced access to and the delivery of coordinated specialty care provided by eConsults resulted in improved efficiency and specialty access, while likely reducing costs and improving patient satisfaction. The improved communication and collaboration among providers with eConsults has also led to overwhelmingly positive feedback from both PCPs and specialists.

Keywords: electronic consultation; access to care; primary care; specialty referral; telehealth.

Orange County’s growing, aging, and diverse population is driving an increased demand for health care.¹ But with the county’s high cost of living and worsening shortage of physicians,^1-3 many of its residents are struggling to access timely, quality, affordable care. Access to specialty care services is especially frustrating for many patients and their providers, both primary care providers (PCPs) and specialists, due to problems with the referral process. Many patients experience increased wait times for a visit with a specialist due to poor communication between providers, insufficient guidance on the information or diagnostic results needed by specialists, and lack of care coordination.^4-6 One promising approach to overcome these challenges is the use of an electronic consultation, or eConsult, in place of a standard in-person referral. An eConsult is an asynchronous, non-face-to-face, provider-to-provider exchange using a secure electronic communication platform. For appropriate referral problems, the patient is able to receive timely access to specialist expertise through electronic referral by their PCP,^7-9 and avoid the time and costs associated with a visit to the specialist,^10,11 such as travel, missed work, co-pays, and child-care expenses. Clinical questions addressed using an eConsult system subsequently free up office visit appointment slots, improving access for patients requiring in-office evaluation.^8,12

Orange County’s only academic health system, the University of California, Irvine (UCI), serves a population of 3.5 million, and its principal priority is providing the communities in the county (which is the sixth largest in United States) and the surrounding region with the highest quality health care possible. Thus, UCI aimed to improve its referral processes and provide timely access to specialty care for its patients by implementing an eConsults program that allows PCPs to efficiently receive specialist recommendations on referral problems that do not require the specialist to evaluate the patient in person. This report describes our experiences with developing and implementing a custom-built eConsults workflow in UCI’s prior electronic health record (EHR) platform, Allscripts, and subsequently transitioning our mature eConsults program to a new EHR system when UCI adopted Epic. UCI is likely the only academic medical center to have experience in successfully implementing eConsults into 2 different EHR systems.

Setting

UCI’s medical center is a 417-bed acute care hospital providing tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health care, and rehabilitation services. It is located in Orange, CA, and serves a diverse population of 3.5 million persons with broad health care needs. With more than 400 specialty and primary care physicians, UCI offers a full scope of acute and general care services. It is also the primary teaching location for UCI medical and nursing students, medical residents, and fellows, and is home to Orange County’s only adult Level I and pediatric Level II trauma centers and the regional burn center.

eConsults Program

We designed the initial eConsults program within UCI’s Allscripts EHR platform. Our information technology (IT) build team developed unique “documents-based” eConsults workflows that simplified the process of initiating requests directly from the EHR and facilitated rapid responses from participating specialties. The requesting provider’s eConsults interface was user-friendly, and referring providers were able to initiate an eConsult easily by selecting the customized eConsult icon from the Allscripts main toolbar. To ensure that all relevant information is provided to the specialists, condition-specific templates are embedded in the requesting provider’s eConsults workflow that allow PCPs to enter a focused, patient-specific clinical question and provide guidance on recommended patient information (eg, health history, laboratory results, and digital images) that may help the specialist provide an informed response. The eConsult templates were adapted from standardized forms developed by partner University of California Health Systems in an initiative funded by the University of California Center for Health Quality and Innovation.

To facilitate timely responses from specialists, an innovative notification system was created in the responding provider’s eConsults workflow to automatically send an email to participating specialists when a new eConsult is requested. The responding provider’s workflow also includes an option for the specialist to decline the eConsult if the case is deemed too complex to be addressed electronically. For every completed eConsult that does not result in an in-person patient evaluation, the requesting provider and responding specialist each receives a modest reimbursement, which was initially paid by UCI Health System funds.

Implementation

The design and implementation of the eConsults program began in November 2014, and was guided by a steering committee that included the chair of the department of medicine, chief medical information officer, primary care and specialty physician leads, IT build team, and a project manager. Early on, members of this committee engaged UCI leadership to affirm support for the program and obtain the IT resources needed to build the eConsults workflow. Regular steering committee meetings were established to discuss the design of the workflow, adapt the clinical content of the referral templates, and develop a provider reimbursement plan. After completion of the workflow build, the eConsults system was tested to identify failure points and obtain feedback from users. Prior to going live, the eConsults program was publicized by members of the steering committee through meetings with primary care groups and email communications. Committee members also hosted in-person training and orientation sessions with PCPs and participating specialists, and distributed tip sheets summarizing the steps to complete the PCP and specialist eConsult workflows.

The eConsults workflow build, testing, and launch were completed within 5 months (April 2015; Figure 1). eConsults went live in the 3 initial specialties (endocrinology, cardiology, and rheumatology) that were interested in participating in the first wave of the program. UCI’s eConsults service has subsequently expanded to 17 total specialties (allergy, cardiology, dermatology, endocrinology, gastroenterology, geriatrics, gynecology, hematology, hepatology, infectious disease, nephrology, neurology, palliative care, psychiatry, pulmonary, rheumatology, and sports medicine).

Two and half years after the eConsults program was implemented in Allscripts, UCI adopted a new EHR platform, Epic. By this time, the eConsults service had grown into a mature program with greater numbers of PCP users and submitted eConsults (Figure 2). Using our experience with the Allscripts build, our IT team was able to efficiently transition the eConsults service to the new EHR system. In contrast to the “documents-based” eConsult workflows on Allscripts, our IT team utilized an “orders-based” strategy on Epic, which followed a more traditional approach to requesting a consultation. We re-launched the service in Epic within 3 months (February 2018). However, both platforms utilized user-friendly workflows to achieve similar goals, and the program has continued to grow with respect to the number of users and eConsults.

Measurement/Analysis

The impact of the program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of PCP users, the number of submitted eConsult requests per PCP, and the number of requests per specialty. The response time for eConsult requests and the self-reported amount of time spent by specialists on the response were also tracked. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback. Provider satisfaction was primarily obtained by soliciting feedback from individual eConsult users.

Implementation of this eConsults program constituted a quality improvement activity and did not require Institutional Review Board review.

 

 

Results

Since the program was launched in April 2015, more than 1400 eConsults have been completed across 17 specialties (Figure 3). There were 654 completed eConsults on the Allscripts platform, and 808 eConsults have been completed using the Epic platform to date. The busiest eConsult specialties were endocrinology (receiving 276, or 19%, of the eConsults requests), hematology (receiving 249 requests, or 17%), infectious disease (receiving 244 requests, or 17% ), and cardiology (receiving 148 requests, or 10%).

The self-reported amount of time specialists spent on the response was different between the 2 EHR systems (Figure 4). On Allscripts, specialists reported that 23% of eConsults took 10 minutes or less to complete, 47% took 11 to 20 minutes, 23% took 21 to 30 minutes, and 7% took more than 30 minutes. On Epic, specialists reported that 42% of eConsults took 10 minutes or less to complete, 44% took 11 to 20 minutes, 12% took 21 to 30 minutes, and 2% took more than 30 minutes. This difference in time spent fielding eConsults likely represents the subtle nuances between Allscripts’ “documents-based” and Epic’s “orders-based” workflows.

As a result of the automated notification system that was introduced early in the eConsults implementation process on Allscripts, the specialty response times were much faster than the expected 3 business days’ turnaround goal instituted by the Center for Health Quality and Innovation initiative, regardless of the EHR platform used. In fact, the average turnaround time for an eConsult response across all specialties was 1 business day, which was similar for both EHR systems (Figure 5). Furthermore, more than 50% of the eConsults on both EHR systems received specialist responses within the same day of the eConsult request (63% on Allscripts, 54% on Epic). There was a small decrease in the percentage of same-day responses when we transitioned to Epic, likely because the functionality of an automated notification email could not be restored in Epic. Regardless, the specialty response times on Epic remained expeditious, likely because the automated notifications on Allscripts instilled good practices for the specialists, and regularly checking for new eConsult requests became an ingrained behavior.

Our most important finding was that approximately 80% of eConsult requests were addressed without the need for an in-office visit with a specialist. This measure was similar for both EHR platforms (83% on Allscripts and 78% on Epic).

Provider feedback has been overwhelmingly positive. PCPs are impressed with the robust educational content of the eConsult responses, since the goal for specialists is to justify their recommendations. Specialists appreciate the convenience and efficiency that eConsults offer, as well as the improved communication and collaboration among physicians. eConsults have been especially beneficial to PCPs at UCI’s Family Health Centers, who are now able to receive subspecialty consultations from UCI specialists despite insurance barriers.

Discussion

Our eConsults program uniquely contrasts with other programs because UCI is likely the only academic medical center to have experience in successfully incorporating eConsults into 2 different EHR systems: initial development of the eConsults workflow in UCI’s existing Allscripts EHR platform, and subsequently transitioning a mature eConsults program to a new EHR system when the institution adopted Epic.

We measured the impact of the eConsults program on access to care by the response time for eConsult requests and the percentage of eConsults that averted an in-office visit with a specialist. We found that the eConsults program at UCI provided our PCPs access to specialist consultations in a timely manner, with much shorter response times than standard in-person referrals. The average turnaround time for an eConsult response we reported is consistent with findings from other studies.^12-15 Additionally, our program was able to address about 80% of its eConsults electronically, helping to reduce unnecessary in-person specialist referrals. In the literature, the percentage of eConsults that avoided an in-person specialist visit varies widely.^8,12-16

We reported very positive feedback from both PCPs and specialists on UCI’s eConsults service. Similarly, other studies described PCP satisfaction with their respective eConsults programs to be uniformly high,^{8,9,13,14,17-19} though some reported that the level of satisfaction among specialists was more varied.^18-21

Lessons Learned

The successful design and implementation of our eConsults program began with assembling the right clinical champions and technology partners for our steering committee. Establishing regular steering committee meetings helped maintain an appropriate timeline for completion of different aspects of the project. Engaging support from UCI’s leadership also provided us with a dedicated IT team that helped us with the build, training resources, troubleshooting issues, and reporting for the project.

Our experience with implementing the eConsults program on 2 different EHR systems highlighted the importance of creating efficient, user-friendly workflows to foster provider adoption and achieve sustainability. Allscripts’ open platform gave our IT team the ability to create a homegrown solution to implementing an eConsult model that was simple and easy to use. The Epic platform’s interoperability allowed us to leverage our learnings from the Allscripts build to efficiently implement eConsults in Epic.

We also found that providing modest incentive payments or reimbursements to both PCPs and specialists for each completed eConsult helps with both adoption and program sustainability. Initially, credit for the eConsult work was paid by internal UCI Health System funds. Two payers, UC Care (a preferred provider organization plan created just for the University of California) and more recently, the Centers for Medicare & Medicaid Services, have agreed to reimburse for outpatient eConsults. Securing additional payers for reimbursement of the eConsult service will not only ensure the program’s long-term sustainability, but also represents an acknowledgment of the value of eConsults in supporting access to care.

Applicability

Other health care settings that are experiencing issues with specialty care access can successfully implement their own eConsults program by employing strategies similar to those described in this report—assembling the right team, creating user-friendly workflows, and providing incentives. Our advice for successful implementation is to clearly communicate your goals to all involved, including primary care, specialists, leadership, and IT partners, and establish with these stakeholders the appropriate support and resources needed to facilitate the development of the program and overcome any barriers to adoption.

Current Status and Future Directions

Our future plans include continuing to optimize the Epic eConsult backend build and workflows using our experience in Allscripts. We have implemented eConsult workflows for use by graduate medical education trainees and advanced practice providers, with attending supervision. Further work is in progress to optimize these workflows, which will allow for appropriate education and supervision without delaying care. Furthermore, we plan to expand the program to include inpatient-to-inpatient and emergency department-to-inpatient eConsults. We will continue to expand the eConsults program by offering additional specialties, engage providers to encourage ongoing participation, and maximize PCP use by continuing to market the program through regular newsletters and email communications. Finally, the eConsults has served as an effective, important resource in the current era of COVID-19 in several ways: it allows for optimization of specialty input in patient care delivery without subjecting more health care workers to unnecessary exposure; saves on utilization of precious personal protective equipment; and enhances our ability to deal with a potential surge by providing access to specialists remotely and electronically all hours of the day, thus expanding care to the evening and weekend hours.

Acknowledgment: The authors thank our steering committee members (Dr. Ralph Cygan, Dr. Andrew Reikes, Dr. Byron Allen, Dr. George Lawry) and IT build team (Lori Bocchicchio, Meghan van Witsen, Jaymee Zillgitt, Tanya Sickles, Dennis Hoang, Jeanette Lisak-Phillips) for their contributions in the design and implementation of our eConsults program. We also thank additional team members Kurt McArthur and Neaktisia Lee for their assistance with generating reports, and Kathy LaPierre, Jennifer Rios, and Debra Webb Torres for their guidance with compliance and billing issues.

Corresponding author: Alpesh N. Amin, MD, MBA, University of California, Irvine, 101 The City Drive South, Building 26, Room 1000, ZC-4076H, Orange, CA 92868; [email protected].

Financial disclosures: None.

From the Department of Medicine, University of California, Irvine, Orange, CA.

Abstract

Background: Orange County’s residents have difficulty accessing timely, quality, affordable specialty care services. As the county’s only academic health system, the University of California, Irvine (UCI) aimed to improve specialty care access for the communities it serves by implementing an electronic consultations (eConsults) program that allows primary care providers (PCPs) to efficiently receive specialist recommendations on referral problems that do not require an in-person evaluation.

Objective: To implement an eConsults program at the UCI that enhances access to and the delivery of coordinated specialty care for lower-complexity referral problems.

Methods: We developed custom solutions to integrate eConsults into UCI’s 2 electronic health record platforms. The impact of the eConsults program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of submitted eConsult requests per PCP, the number of completed responses per specialty, and the response time for eConsult requests. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback.

Results: Over 4.5 years, more than 1400 successful eConsults have been completed, and the program has expanded to 17 specialties. The average turnaround time for an eConsult response across all specialties was 1 business day. Moreover, more than 50% of the eConsults received specialty responses within the same day of the eConsult request. Most important, about 80% of eConsult requests were addressed without the need for an in-office visit with a specialist.

Conclusion: The enhanced access to and the delivery of coordinated specialty care provided by eConsults resulted in improved efficiency and specialty access, while likely reducing costs and improving patient satisfaction. The improved communication and collaboration among providers with eConsults has also led to overwhelmingly positive feedback from both PCPs and specialists.

Keywords: electronic consultation; access to care; primary care; specialty referral; telehealth.

Orange County’s growing, aging, and diverse population is driving an increased demand for health care.¹ But with the county’s high cost of living and worsening shortage of physicians,^1-3 many of its residents are struggling to access timely, quality, affordable care. Access to specialty care services is especially frustrating for many patients and their providers, both primary care providers (PCPs) and specialists, due to problems with the referral process. Many patients experience increased wait times for a visit with a specialist due to poor communication between providers, insufficient guidance on the information or diagnostic results needed by specialists, and lack of care coordination.^4-6 One promising approach to overcome these challenges is the use of an electronic consultation, or eConsult, in place of a standard in-person referral. An eConsult is an asynchronous, non-face-to-face, provider-to-provider exchange using a secure electronic communication platform. For appropriate referral problems, the patient is able to receive timely access to specialist expertise through electronic referral by their PCP,^7-9 and avoid the time and costs associated with a visit to the specialist,^10,11 such as travel, missed work, co-pays, and child-care expenses. Clinical questions addressed using an eConsult system subsequently free up office visit appointment slots, improving access for patients requiring in-office evaluation.^8,12

Orange County’s only academic health system, the University of California, Irvine (UCI), serves a population of 3.5 million, and its principal priority is providing the communities in the county (which is the sixth largest in United States) and the surrounding region with the highest quality health care possible. Thus, UCI aimed to improve its referral processes and provide timely access to specialty care for its patients by implementing an eConsults program that allows PCPs to efficiently receive specialist recommendations on referral problems that do not require the specialist to evaluate the patient in person. This report describes our experiences with developing and implementing a custom-built eConsults workflow in UCI’s prior electronic health record (EHR) platform, Allscripts, and subsequently transitioning our mature eConsults program to a new EHR system when UCI adopted Epic. UCI is likely the only academic medical center to have experience in successfully implementing eConsults into 2 different EHR systems.

Setting

UCI’s medical center is a 417-bed acute care hospital providing tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health care, and rehabilitation services. It is located in Orange, CA, and serves a diverse population of 3.5 million persons with broad health care needs. With more than 400 specialty and primary care physicians, UCI offers a full scope of acute and general care services. It is also the primary teaching location for UCI medical and nursing students, medical residents, and fellows, and is home to Orange County’s only adult Level I and pediatric Level II trauma centers and the regional burn center.

eConsults Program

We designed the initial eConsults program within UCI’s Allscripts EHR platform. Our information technology (IT) build team developed unique “documents-based” eConsults workflows that simplified the process of initiating requests directly from the EHR and facilitated rapid responses from participating specialties. The requesting provider’s eConsults interface was user-friendly, and referring providers were able to initiate an eConsult easily by selecting the customized eConsult icon from the Allscripts main toolbar. To ensure that all relevant information is provided to the specialists, condition-specific templates are embedded in the requesting provider’s eConsults workflow that allow PCPs to enter a focused, patient-specific clinical question and provide guidance on recommended patient information (eg, health history, laboratory results, and digital images) that may help the specialist provide an informed response. The eConsult templates were adapted from standardized forms developed by partner University of California Health Systems in an initiative funded by the University of California Center for Health Quality and Innovation.

To facilitate timely responses from specialists, an innovative notification system was created in the responding provider’s eConsults workflow to automatically send an email to participating specialists when a new eConsult is requested. The responding provider’s workflow also includes an option for the specialist to decline the eConsult if the case is deemed too complex to be addressed electronically. For every completed eConsult that does not result in an in-person patient evaluation, the requesting provider and responding specialist each receives a modest reimbursement, which was initially paid by UCI Health System funds.

Implementation

The design and implementation of the eConsults program began in November 2014, and was guided by a steering committee that included the chair of the department of medicine, chief medical information officer, primary care and specialty physician leads, IT build team, and a project manager. Early on, members of this committee engaged UCI leadership to affirm support for the program and obtain the IT resources needed to build the eConsults workflow. Regular steering committee meetings were established to discuss the design of the workflow, adapt the clinical content of the referral templates, and develop a provider reimbursement plan. After completion of the workflow build, the eConsults system was tested to identify failure points and obtain feedback from users. Prior to going live, the eConsults program was publicized by members of the steering committee through meetings with primary care groups and email communications. Committee members also hosted in-person training and orientation sessions with PCPs and participating specialists, and distributed tip sheets summarizing the steps to complete the PCP and specialist eConsult workflows.

The eConsults workflow build, testing, and launch were completed within 5 months (April 2015; Figure 1). eConsults went live in the 3 initial specialties (endocrinology, cardiology, and rheumatology) that were interested in participating in the first wave of the program. UCI’s eConsults service has subsequently expanded to 17 total specialties (allergy, cardiology, dermatology, endocrinology, gastroenterology, geriatrics, gynecology, hematology, hepatology, infectious disease, nephrology, neurology, palliative care, psychiatry, pulmonary, rheumatology, and sports medicine).

Two and half years after the eConsults program was implemented in Allscripts, UCI adopted a new EHR platform, Epic. By this time, the eConsults service had grown into a mature program with greater numbers of PCP users and submitted eConsults (Figure 2). Using our experience with the Allscripts build, our IT team was able to efficiently transition the eConsults service to the new EHR system. In contrast to the “documents-based” eConsult workflows on Allscripts, our IT team utilized an “orders-based” strategy on Epic, which followed a more traditional approach to requesting a consultation. We re-launched the service in Epic within 3 months (February 2018). However, both platforms utilized user-friendly workflows to achieve similar goals, and the program has continued to grow with respect to the number of users and eConsults.

Measurement/Analysis

The impact of the program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of PCP users, the number of submitted eConsult requests per PCP, and the number of requests per specialty. The response time for eConsult requests and the self-reported amount of time spent by specialists on the response were also tracked. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback. Provider satisfaction was primarily obtained by soliciting feedback from individual eConsult users.

Implementation of this eConsults program constituted a quality improvement activity and did not require Institutional Review Board review.

 

 

Results

Since the program was launched in April 2015, more than 1400 eConsults have been completed across 17 specialties (Figure 3). There were 654 completed eConsults on the Allscripts platform, and 808 eConsults have been completed using the Epic platform to date. The busiest eConsult specialties were endocrinology (receiving 276, or 19%, of the eConsults requests), hematology (receiving 249 requests, or 17%), infectious disease (receiving 244 requests, or 17% ), and cardiology (receiving 148 requests, or 10%).

The self-reported amount of time specialists spent on the response was different between the 2 EHR systems (Figure 4). On Allscripts, specialists reported that 23% of eConsults took 10 minutes or less to complete, 47% took 11 to 20 minutes, 23% took 21 to 30 minutes, and 7% took more than 30 minutes. On Epic, specialists reported that 42% of eConsults took 10 minutes or less to complete, 44% took 11 to 20 minutes, 12% took 21 to 30 minutes, and 2% took more than 30 minutes. This difference in time spent fielding eConsults likely represents the subtle nuances between Allscripts’ “documents-based” and Epic’s “orders-based” workflows.

As a result of the automated notification system that was introduced early in the eConsults implementation process on Allscripts, the specialty response times were much faster than the expected 3 business days’ turnaround goal instituted by the Center for Health Quality and Innovation initiative, regardless of the EHR platform used. In fact, the average turnaround time for an eConsult response across all specialties was 1 business day, which was similar for both EHR systems (Figure 5). Furthermore, more than 50% of the eConsults on both EHR systems received specialist responses within the same day of the eConsult request (63% on Allscripts, 54% on Epic). There was a small decrease in the percentage of same-day responses when we transitioned to Epic, likely because the functionality of an automated notification email could not be restored in Epic. Regardless, the specialty response times on Epic remained expeditious, likely because the automated notifications on Allscripts instilled good practices for the specialists, and regularly checking for new eConsult requests became an ingrained behavior.

Our most important finding was that approximately 80% of eConsult requests were addressed without the need for an in-office visit with a specialist. This measure was similar for both EHR platforms (83% on Allscripts and 78% on Epic).

Provider feedback has been overwhelmingly positive. PCPs are impressed with the robust educational content of the eConsult responses, since the goal for specialists is to justify their recommendations. Specialists appreciate the convenience and efficiency that eConsults offer, as well as the improved communication and collaboration among physicians. eConsults have been especially beneficial to PCPs at UCI’s Family Health Centers, who are now able to receive subspecialty consultations from UCI specialists despite insurance barriers.

Discussion

Our eConsults program uniquely contrasts with other programs because UCI is likely the only academic medical center to have experience in successfully incorporating eConsults into 2 different EHR systems: initial development of the eConsults workflow in UCI’s existing Allscripts EHR platform, and subsequently transitioning a mature eConsults program to a new EHR system when the institution adopted Epic.

We measured the impact of the eConsults program on access to care by the response time for eConsult requests and the percentage of eConsults that averted an in-office visit with a specialist. We found that the eConsults program at UCI provided our PCPs access to specialist consultations in a timely manner, with much shorter response times than standard in-person referrals. The average turnaround time for an eConsult response we reported is consistent with findings from other studies.^12-15 Additionally, our program was able to address about 80% of its eConsults electronically, helping to reduce unnecessary in-person specialist referrals. In the literature, the percentage of eConsults that avoided an in-person specialist visit varies widely.^8,12-16

We reported very positive feedback from both PCPs and specialists on UCI’s eConsults service. Similarly, other studies described PCP satisfaction with their respective eConsults programs to be uniformly high,^{8,9,13,14,17-19} though some reported that the level of satisfaction among specialists was more varied.^18-21

Lessons Learned

The successful design and implementation of our eConsults program began with assembling the right clinical champions and technology partners for our steering committee. Establishing regular steering committee meetings helped maintain an appropriate timeline for completion of different aspects of the project. Engaging support from UCI’s leadership also provided us with a dedicated IT team that helped us with the build, training resources, troubleshooting issues, and reporting for the project.

Our experience with implementing the eConsults program on 2 different EHR systems highlighted the importance of creating efficient, user-friendly workflows to foster provider adoption and achieve sustainability. Allscripts’ open platform gave our IT team the ability to create a homegrown solution to implementing an eConsult model that was simple and easy to use. The Epic platform’s interoperability allowed us to leverage our learnings from the Allscripts build to efficiently implement eConsults in Epic.

We also found that providing modest incentive payments or reimbursements to both PCPs and specialists for each completed eConsult helps with both adoption and program sustainability. Initially, credit for the eConsult work was paid by internal UCI Health System funds. Two payers, UC Care (a preferred provider organization plan created just for the University of California) and more recently, the Centers for Medicare & Medicaid Services, have agreed to reimburse for outpatient eConsults. Securing additional payers for reimbursement of the eConsult service will not only ensure the program’s long-term sustainability, but also represents an acknowledgment of the value of eConsults in supporting access to care.

Applicability

Other health care settings that are experiencing issues with specialty care access can successfully implement their own eConsults program by employing strategies similar to those described in this report—assembling the right team, creating user-friendly workflows, and providing incentives. Our advice for successful implementation is to clearly communicate your goals to all involved, including primary care, specialists, leadership, and IT partners, and establish with these stakeholders the appropriate support and resources needed to facilitate the development of the program and overcome any barriers to adoption.

Current Status and Future Directions

Our future plans include continuing to optimize the Epic eConsult backend build and workflows using our experience in Allscripts. We have implemented eConsult workflows for use by graduate medical education trainees and advanced practice providers, with attending supervision. Further work is in progress to optimize these workflows, which will allow for appropriate education and supervision without delaying care. Furthermore, we plan to expand the program to include inpatient-to-inpatient and emergency department-to-inpatient eConsults. We will continue to expand the eConsults program by offering additional specialties, engage providers to encourage ongoing participation, and maximize PCP use by continuing to market the program through regular newsletters and email communications. Finally, the eConsults has served as an effective, important resource in the current era of COVID-19 in several ways: it allows for optimization of specialty input in patient care delivery without subjecting more health care workers to unnecessary exposure; saves on utilization of precious personal protective equipment; and enhances our ability to deal with a potential surge by providing access to specialists remotely and electronically all hours of the day, thus expanding care to the evening and weekend hours.

Acknowledgment: The authors thank our steering committee members (Dr. Ralph Cygan, Dr. Andrew Reikes, Dr. Byron Allen, Dr. George Lawry) and IT build team (Lori Bocchicchio, Meghan van Witsen, Jaymee Zillgitt, Tanya Sickles, Dennis Hoang, Jeanette Lisak-Phillips) for their contributions in the design and implementation of our eConsults program. We also thank additional team members Kurt McArthur and Neaktisia Lee for their assistance with generating reports, and Kathy LaPierre, Jennifer Rios, and Debra Webb Torres for their guidance with compliance and billing issues.

Corresponding author: Alpesh N. Amin, MD, MBA, University of California, Irvine, 101 The City Drive South, Building 26, Room 1000, ZC-4076H, Orange, CA 92868; [email protected].

Financial disclosures: None.

From the Department of Medicine, University of California, Irvine, Orange, CA.

Abstract

Background: Orange County’s residents have difficulty accessing timely, quality, affordable specialty care services. As the county’s only academic health system, the University of California, Irvine (UCI) aimed to improve specialty care access for the communities it serves by implementing an electronic consultations (eConsults) program that allows primary care providers (PCPs) to efficiently receive specialist recommendations on referral problems that do not require an in-person evaluation.

Objective: To implement an eConsults program at the UCI that enhances access to and the delivery of coordinated specialty care for lower-complexity referral problems.

Methods: We developed custom solutions to integrate eConsults into UCI’s 2 electronic health record platforms. The impact of the eConsults program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of submitted eConsult requests per PCP, the number of completed responses per specialty, and the response time for eConsult requests. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback.

Results: Over 4.5 years, more than 1400 successful eConsults have been completed, and the program has expanded to 17 specialties. The average turnaround time for an eConsult response across all specialties was 1 business day. Moreover, more than 50% of the eConsults received specialty responses within the same day of the eConsult request. Most important, about 80% of eConsult requests were addressed without the need for an in-office visit with a specialist.

Conclusion: The enhanced access to and the delivery of coordinated specialty care provided by eConsults resulted in improved efficiency and specialty access, while likely reducing costs and improving patient satisfaction. The improved communication and collaboration among providers with eConsults has also led to overwhelmingly positive feedback from both PCPs and specialists.

Keywords: electronic consultation; access to care; primary care; specialty referral; telehealth.

Orange County’s growing, aging, and diverse population is driving an increased demand for health care.¹ But with the county’s high cost of living and worsening shortage of physicians,^1-3 many of its residents are struggling to access timely, quality, affordable care. Access to specialty care services is especially frustrating for many patients and their providers, both primary care providers (PCPs) and specialists, due to problems with the referral process. Many patients experience increased wait times for a visit with a specialist due to poor communication between providers, insufficient guidance on the information or diagnostic results needed by specialists, and lack of care coordination.^4-6 One promising approach to overcome these challenges is the use of an electronic consultation, or eConsult, in place of a standard in-person referral. An eConsult is an asynchronous, non-face-to-face, provider-to-provider exchange using a secure electronic communication platform. For appropriate referral problems, the patient is able to receive timely access to specialist expertise through electronic referral by their PCP,^7-9 and avoid the time and costs associated with a visit to the specialist,^10,11 such as travel, missed work, co-pays, and child-care expenses. Clinical questions addressed using an eConsult system subsequently free up office visit appointment slots, improving access for patients requiring in-office evaluation.^8,12

Orange County’s only academic health system, the University of California, Irvine (UCI), serves a population of 3.5 million, and its principal priority is providing the communities in the county (which is the sixth largest in United States) and the surrounding region with the highest quality health care possible. Thus, UCI aimed to improve its referral processes and provide timely access to specialty care for its patients by implementing an eConsults program that allows PCPs to efficiently receive specialist recommendations on referral problems that do not require the specialist to evaluate the patient in person. This report describes our experiences with developing and implementing a custom-built eConsults workflow in UCI’s prior electronic health record (EHR) platform, Allscripts, and subsequently transitioning our mature eConsults program to a new EHR system when UCI adopted Epic. UCI is likely the only academic medical center to have experience in successfully implementing eConsults into 2 different EHR systems.

Setting

UCI’s medical center is a 417-bed acute care hospital providing tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health care, and rehabilitation services. It is located in Orange, CA, and serves a diverse population of 3.5 million persons with broad health care needs. With more than 400 specialty and primary care physicians, UCI offers a full scope of acute and general care services. It is also the primary teaching location for UCI medical and nursing students, medical residents, and fellows, and is home to Orange County’s only adult Level I and pediatric Level II trauma centers and the regional burn center.

eConsults Program

We designed the initial eConsults program within UCI’s Allscripts EHR platform. Our information technology (IT) build team developed unique “documents-based” eConsults workflows that simplified the process of initiating requests directly from the EHR and facilitated rapid responses from participating specialties. The requesting provider’s eConsults interface was user-friendly, and referring providers were able to initiate an eConsult easily by selecting the customized eConsult icon from the Allscripts main toolbar. To ensure that all relevant information is provided to the specialists, condition-specific templates are embedded in the requesting provider’s eConsults workflow that allow PCPs to enter a focused, patient-specific clinical question and provide guidance on recommended patient information (eg, health history, laboratory results, and digital images) that may help the specialist provide an informed response. The eConsult templates were adapted from standardized forms developed by partner University of California Health Systems in an initiative funded by the University of California Center for Health Quality and Innovation.

To facilitate timely responses from specialists, an innovative notification system was created in the responding provider’s eConsults workflow to automatically send an email to participating specialists when a new eConsult is requested. The responding provider’s workflow also includes an option for the specialist to decline the eConsult if the case is deemed too complex to be addressed electronically. For every completed eConsult that does not result in an in-person patient evaluation, the requesting provider and responding specialist each receives a modest reimbursement, which was initially paid by UCI Health System funds.

Implementation

The design and implementation of the eConsults program began in November 2014, and was guided by a steering committee that included the chair of the department of medicine, chief medical information officer, primary care and specialty physician leads, IT build team, and a project manager. Early on, members of this committee engaged UCI leadership to affirm support for the program and obtain the IT resources needed to build the eConsults workflow. Regular steering committee meetings were established to discuss the design of the workflow, adapt the clinical content of the referral templates, and develop a provider reimbursement plan. After completion of the workflow build, the eConsults system was tested to identify failure points and obtain feedback from users. Prior to going live, the eConsults program was publicized by members of the steering committee through meetings with primary care groups and email communications. Committee members also hosted in-person training and orientation sessions with PCPs and participating specialists, and distributed tip sheets summarizing the steps to complete the PCP and specialist eConsult workflows.

The eConsults workflow build, testing, and launch were completed within 5 months (April 2015; Figure 1). eConsults went live in the 3 initial specialties (endocrinology, cardiology, and rheumatology) that were interested in participating in the first wave of the program. UCI’s eConsults service has subsequently expanded to 17 total specialties (allergy, cardiology, dermatology, endocrinology, gastroenterology, geriatrics, gynecology, hematology, hepatology, infectious disease, nephrology, neurology, palliative care, psychiatry, pulmonary, rheumatology, and sports medicine).

Two and half years after the eConsults program was implemented in Allscripts, UCI adopted a new EHR platform, Epic. By this time, the eConsults service had grown into a mature program with greater numbers of PCP users and submitted eConsults (Figure 2). Using our experience with the Allscripts build, our IT team was able to efficiently transition the eConsults service to the new EHR system. In contrast to the “documents-based” eConsult workflows on Allscripts, our IT team utilized an “orders-based” strategy on Epic, which followed a more traditional approach to requesting a consultation. We re-launched the service in Epic within 3 months (February 2018). However, both platforms utilized user-friendly workflows to achieve similar goals, and the program has continued to grow with respect to the number of users and eConsults.

Measurement/Analysis

The impact of the program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of PCP users, the number of submitted eConsult requests per PCP, and the number of requests per specialty. The response time for eConsult requests and the self-reported amount of time spent by specialists on the response were also tracked. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback. Provider satisfaction was primarily obtained by soliciting feedback from individual eConsult users.

Implementation of this eConsults program constituted a quality improvement activity and did not require Institutional Review Board review.

 

 

Results

Since the program was launched in April 2015, more than 1400 eConsults have been completed across 17 specialties (Figure 3). There were 654 completed eConsults on the Allscripts platform, and 808 eConsults have been completed using the Epic platform to date. The busiest eConsult specialties were endocrinology (receiving 276, or 19%, of the eConsults requests), hematology (receiving 249 requests, or 17%), infectious disease (receiving 244 requests, or 17% ), and cardiology (receiving 148 requests, or 10%).

The self-reported amount of time specialists spent on the response was different between the 2 EHR systems (Figure 4). On Allscripts, specialists reported that 23% of eConsults took 10 minutes or less to complete, 47% took 11 to 20 minutes, 23% took 21 to 30 minutes, and 7% took more than 30 minutes. On Epic, specialists reported that 42% of eConsults took 10 minutes or less to complete, 44% took 11 to 20 minutes, 12% took 21 to 30 minutes, and 2% took more than 30 minutes. This difference in time spent fielding eConsults likely represents the subtle nuances between Allscripts’ “documents-based” and Epic’s “orders-based” workflows.

As a result of the automated notification system that was introduced early in the eConsults implementation process on Allscripts, the specialty response times were much faster than the expected 3 business days’ turnaround goal instituted by the Center for Health Quality and Innovation initiative, regardless of the EHR platform used. In fact, the average turnaround time for an eConsult response across all specialties was 1 business day, which was similar for both EHR systems (Figure 5). Furthermore, more than 50% of the eConsults on both EHR systems received specialist responses within the same day of the eConsult request (63% on Allscripts, 54% on Epic). There was a small decrease in the percentage of same-day responses when we transitioned to Epic, likely because the functionality of an automated notification email could not be restored in Epic. Regardless, the specialty response times on Epic remained expeditious, likely because the automated notifications on Allscripts instilled good practices for the specialists, and regularly checking for new eConsult requests became an ingrained behavior.

Our most important finding was that approximately 80% of eConsult requests were addressed without the need for an in-office visit with a specialist. This measure was similar for both EHR platforms (83% on Allscripts and 78% on Epic).

Provider feedback has been overwhelmingly positive. PCPs are impressed with the robust educational content of the eConsult responses, since the goal for specialists is to justify their recommendations. Specialists appreciate the convenience and efficiency that eConsults offer, as well as the improved communication and collaboration among physicians. eConsults have been especially beneficial to PCPs at UCI’s Family Health Centers, who are now able to receive subspecialty consultations from UCI specialists despite insurance barriers.

Discussion

Our eConsults program uniquely contrasts with other programs because UCI is likely the only academic medical center to have experience in successfully incorporating eConsults into 2 different EHR systems: initial development of the eConsults workflow in UCI’s existing Allscripts EHR platform, and subsequently transitioning a mature eConsults program to a new EHR system when the institution adopted Epic.

We measured the impact of the eConsults program on access to care by the response time for eConsult requests and the percentage of eConsults that averted an in-office visit with a specialist. We found that the eConsults program at UCI provided our PCPs access to specialist consultations in a timely manner, with much shorter response times than standard in-person referrals. The average turnaround time for an eConsult response we reported is consistent with findings from other studies.^12-15 Additionally, our program was able to address about 80% of its eConsults electronically, helping to reduce unnecessary in-person specialist referrals. In the literature, the percentage of eConsults that avoided an in-person specialist visit varies widely.^8,12-16

We reported very positive feedback from both PCPs and specialists on UCI’s eConsults service. Similarly, other studies described PCP satisfaction with their respective eConsults programs to be uniformly high,^{8,9,13,14,17-19} though some reported that the level of satisfaction among specialists was more varied.^18-21

Lessons Learned

The successful design and implementation of our eConsults program began with assembling the right clinical champions and technology partners for our steering committee. Establishing regular steering committee meetings helped maintain an appropriate timeline for completion of different aspects of the project. Engaging support from UCI’s leadership also provided us with a dedicated IT team that helped us with the build, training resources, troubleshooting issues, and reporting for the project.

Our experience with implementing the eConsults program on 2 different EHR systems highlighted the importance of creating efficient, user-friendly workflows to foster provider adoption and achieve sustainability. Allscripts’ open platform gave our IT team the ability to create a homegrown solution to implementing an eConsult model that was simple and easy to use. The Epic platform’s interoperability allowed us to leverage our learnings from the Allscripts build to efficiently implement eConsults in Epic.

We also found that providing modest incentive payments or reimbursements to both PCPs and specialists for each completed eConsult helps with both adoption and program sustainability. Initially, credit for the eConsult work was paid by internal UCI Health System funds. Two payers, UC Care (a preferred provider organization plan created just for the University of California) and more recently, the Centers for Medicare & Medicaid Services, have agreed to reimburse for outpatient eConsults. Securing additional payers for reimbursement of the eConsult service will not only ensure the program’s long-term sustainability, but also represents an acknowledgment of the value of eConsults in supporting access to care.

Applicability

Other health care settings that are experiencing issues with specialty care access can successfully implement their own eConsults program by employing strategies similar to those described in this report—assembling the right team, creating user-friendly workflows, and providing incentives. Our advice for successful implementation is to clearly communicate your goals to all involved, including primary care, specialists, leadership, and IT partners, and establish with these stakeholders the appropriate support and resources needed to facilitate the development of the program and overcome any barriers to adoption.

Current Status and Future Directions

Our future plans include continuing to optimize the Epic eConsult backend build and workflows using our experience in Allscripts. We have implemented eConsult workflows for use by graduate medical education trainees and advanced practice providers, with attending supervision. Further work is in progress to optimize these workflows, which will allow for appropriate education and supervision without delaying care. Furthermore, we plan to expand the program to include inpatient-to-inpatient and emergency department-to-inpatient eConsults. We will continue to expand the eConsults program by offering additional specialties, engage providers to encourage ongoing participation, and maximize PCP use by continuing to market the program through regular newsletters and email communications. Finally, the eConsults has served as an effective, important resource in the current era of COVID-19 in several ways: it allows for optimization of specialty input in patient care delivery without subjecting more health care workers to unnecessary exposure; saves on utilization of precious personal protective equipment; and enhances our ability to deal with a potential surge by providing access to specialists remotely and electronically all hours of the day, thus expanding care to the evening and weekend hours.

Acknowledgment: The authors thank our steering committee members (Dr. Ralph Cygan, Dr. Andrew Reikes, Dr. Byron Allen, Dr. George Lawry) and IT build team (Lori Bocchicchio, Meghan van Witsen, Jaymee Zillgitt, Tanya Sickles, Dennis Hoang, Jeanette Lisak-Phillips) for their contributions in the design and implementation of our eConsults program. We also thank additional team members Kurt McArthur and Neaktisia Lee for their assistance with generating reports, and Kathy LaPierre, Jennifer Rios, and Debra Webb Torres for their guidance with compliance and billing issues.

Corresponding author: Alpesh N. Amin, MD, MBA, University of California, Irvine, 101 The City Drive South, Building 26, Room 1000, ZC-4076H, Orange, CA 92868; [email protected].

Financial disclosures: None.

From Western Michigan University, Homer Stryker MD School of Medicine, Kalamazoo, MI (Dr. Vaillant and Dr. Kavanaugh), Ferris State University, Grand Rapids, MI (Dr. Mersfelder), and Bronson Methodist Hospital, Kalamazoo, MI (Dr. Maynard).

Abstract

• Background: Procalcitonin has emerged as an important marker of sepsis and lung infections of bacterial origin. The role of procalcitonin in guiding antibiotic stewardship in lower respiratory tract infections and sepsis has been extensively studied, and use of this biomarker has been shown to decrease antibiotic usage in clinical trials. We sought to evaluate the impact of a pharmacist-driven initiative regarding discontinuation of antibiotics utilizing procalcitonin levels at a community teaching hospital.
• Methods: We retrospectively gathered baseline data on adult patients admitted to a community teaching hospital who were 18 years of age and older, under the care of an inpatient service, and had a single procalcitonin level < 0.25 mcg/L obtained during admission. We then prospectively identified an intervention group of similar patients using a web-based, real-time clinical surveillance system. When a low procalcitonin level was identified in the intervention group, the participating clinical pharmacists screened for antibiotic use and the indication(s), determined whether the antibiotic could be discontinued based on the low procalcitonin level and the absence of another indication for antibiotics, and, when appropriate, contacted the patient’s health care provider via telephone to discuss possible antibiotic discontinuation. The total antibiotic treatment duration was compared between the baseline and intervention groups.
• Results: A total of 172 patients were included in this study (86 in each group). The duration of antibiotic use was not significantly different between the baseline (3.14 ± 4.04 days) and the intervention (3.34 ± 2.8 days) groups (P = 0.1083). Other patient demographics did not influence antibiotic duration.
• Conclusion: Our study did not demonstrate a difference in total antibiotic treatment duration with the utilization of procalcitonin and an oral communication intervention made by a clinical pharmacist at a community-based teaching hospital. Outside of clinical trials, and in the absence of an algorithmic approach, procalcitonin has not consistently been shown to aid in the diagnosis and treatment of infectious diseases. It is important to have a comprehensive antimicrobial stewardship program to reduce antibiotic use and effectively use laboratory values.

Keywords: antibiotic use; bacterial infection; biomarkers; procalcitonin.

Procalcitonin is the precursor of the hormone calcitonin, which is normally produced in the parafollicular cells of the thyroid gland under physiological conditions.¹ However, procalcitonin is also released in response to a proinflammatory stimulus, especially that of bacterial origin.¹ The source of the procalcitonin surge seen during proinflammatory states is not the parafollicular cells of the thyroid, but rather the neuroendocrine cells of the lung and intestine.¹ Stimulants of procalcitonin in these scenarios include bacterial endotoxin, tumor necrosis factor, and interleukin-6.^1,2 Due to these observations, procalcitonin has emerged as an important marker of sepsis and lung infections of bacterial origin.³

The role of procalcitonin in guiding antibiotic stewardship in lower respiratory tract infections and sepsis has been extensively studied.^4,5 Various randomized controlled trials have shown that antibiotic stewardship guided by procalcitonin levels resulted in lower rates of antibiotic initiation and shorter duration of antibiotic use.^4-6 Similar results were obtained in prospective studies evaluating its role in patients with chronic obstructive pulmonary disease and sepsis.^7,8 Based on these data, protocol-driven procalcitonin-guided antibiotic stewardship appears beneficial.

Many of these studies employed rigorous protocols. Studies of procalcitonin use in a so-called real-world setting, in which the provider can order and use procalcitonin levels without the use of protocols, are limited. The objective of our study was to evaluate the impact of a pharmacist-driven initiative on discontinuing antibiotics, if indicated, utilizing single procalcitonin measurement results of < 0.25 mcg/L at a community teaching hospital.

Methods

Our study utilized a 2-phase approach. The first phase was a retrospective chart review to establish baseline data regarding adult inpatients with a low procalcitonin level; these patients were randomly selected over a 1-year period (2017). Patients were included if they were 18 years of age or older, under the care of an inpatient service, and had a single procalcitonin level < 0.25 mcg/L obtained during their admission. Patients admitted to the intensive care unit were excluded. In the second phase, we prospectively identified similar patients admitted between January and March 2018 using a web-based, real-time clinical surveillance system. When patients with low procalcitonin levels were identified, 2 participating clinical pharmacists screened for antibiotic use and indication. If it was determined that the antibiotic could be discontinued as a result of the low procalcitonin level and no additional indication for antibiotics was present, the pharmacist contacted the patient’s health care provider via telephone to discuss possible antibiotic discontinuation. Data collected before and after the intervention included total antibiotic treatment duration, white blood cell count, maximum temperature, age, and procalcitonin level.

A sample size of 86 was calculated to provide an alpha of 0.05 and a power of 0.8. A nonparametric Wilcoxon 2-sample test was used to test for a difference in duration of antibiotic treatment between the baseline and intervention groups. A nonparametric test was used due to right-skewed data. All patients were included in the group analysis, regardless of antibiotic use, as the procalcitonin level may have been used in the decision to initiate antibiotics, and this is more representative of a real-world application of the test. This allowed for detection of a significant decrease of 2 days in antibiotic duration post intervention, with a 10% margin to compensate for potential missing data. Data from 86 patients obtained prior to the pharmacist intervention acted as a control comparison group. Statistical analysis was performed using SAS 9.4.

Results

A total of 172 patients were included in this study: 86 patients prior to the intervention, and 86 after implementation. Baseline demographics, laboratory values, vitals, and principal diagnoses for both groups are shown in Table 1 and Table 2. The most common indications for procalcitonin measurement were pneumonia (45.9%), chronic obstructive pulmonary disease (15.7%), and sepsis (14.5%). The remaining diagnoses were encephalopathy, fever and leukocytosis, skin and soft tissue infection, urinary tract infection or pyelonephritis, bone and joint infection, meningitis, intra-abdominal infection, and asthma exacerbation.

Antibiotic therapy was initiated in 68% of the patients overall, 59% in the baseline group and 76% in the intervention group. The duration of antibiotic use was not significantly different between the baseline (3.14 ± 4.04 days) and intervention (3.34 ± 2.8 days) groups (P = 0.1083). Furthermore, antibiotic treatment duration did not vary significantly with patient age, white blood cell count, maximum temperature, or procalcitonin level in either group. Although there was no difference in total antibiotic treatment duration, a post-hoc analysis revealed a 0.6-day decrease in the interval between the date of procalcitonin measurement and the stop date of antibiotics in the intervention group. The average time from admission to obtaining a procalcitonin level was 3 days in the baseline group and 2 days in the intervention group.

Discussion

Our study did not demonstrate a difference in total antibiotic treatment duration with procalcitonin measurement and an oral communication intervention made by a clinical pharmacist at a community teaching hospital with a well-established antimicrobial stewardship program. This may be due to several factors. First, the providers did not receive ongoing education regarding the appropriate use or interpretation of procalcitonin. The procalcitonin result in the electronic health record references the risk for progression to severe sepsis and/or septic shock, but does not indicate how to use procalcitonin as an aid in antibiotic decision-making. However, a recent study in patients with lower respiratory tract infections treated by providers who had been educated on the use of procalcitonin failed to find a reduction in total antibiotic use.⁹ Second, our study included hospital-wide use of procalcitonin, and was not limited to infections for which procalcitonin use has the strongest evidence (eg, upper respiratory tract infections, pneumonia, sepsis). Thus, providers may have been less likely to use protocolized guidelines. Last, we did not limit the data on antibiotic duration to patients with a procalcitonin level obtained within a defined time frame from antibiotic initiation or time of admission, and some patients had procalcitonin levels measured several days into their hospital stay. While this is likely to have skewed the data in favor of longer antibiotic treatment courses, it also represents a more realistic way in which this laboratory test is being used. Our post-hoc finding of earlier discontinuation of antibiotics after procalcitonin measurement suggests that our intervention may have influenced the decision to discontinue antibiotics. Such an effect may be augmented if procalcitonin is measured earlier in a hospital admission.

Previous studies have also failed to show that the use of procalcitonin decreased duration of antibiotics.^9,10 In the aforementioned study regarding real-world outcomes in patients with lower respiratory tract infections, antibiotic duration was not reduced, despite provider education.⁹ A large observational study that evaluated real-world outcomes in intensive care unit patients did not find decreased antibiotic use or improved outcomes with procalcitonin use.¹⁰ With these large studies evaluating the 2 most common infectious diseases for which procalcitonin has previously been found to have clinical benefit, it is important for institutions to re-evaluate how procalcitonin is being utilized by providers. Furthermore, institutions should explore ways to optimize procalcitonin use and decrease unnecessary health care costs. Notably, the current community-acquired pneumonia guidelines recommend against routine use of procalcitonin.¹¹

Conclusion

Outside of clinical trials, and in the absence of an algorithmic approach, procalcitonin has not consistently been shown to aid in the diagnosis or treatment of infectious diseases. It is important to have a comprehensive antimicrobial stewardship program that includes an algorithmic protocol to promote appropriate laboratory testing and reduce total antibiotic use. In addition to improved communication with providers, other interventions need to be investigated to effectively use this biomarker or limit its use.

Acknowledgment: The authors thank the Western Michigan University Department of Epidemiology and Biostatistics for their assistance in preparing this article.

Corresponding author: James Vaillant, MD, Western Michigan University, Homer Stryker MD School of Medicine, 1000 Oakland Drive, Kalamazoo, MI, 49008; [email protected].

Financial disclosures: None.

From Western Michigan University, Homer Stryker MD School of Medicine, Kalamazoo, MI (Dr. Vaillant and Dr. Kavanaugh), Ferris State University, Grand Rapids, MI (Dr. Mersfelder), and Bronson Methodist Hospital, Kalamazoo, MI (Dr. Maynard).

Abstract

• Background: Procalcitonin has emerged as an important marker of sepsis and lung infections of bacterial origin. The role of procalcitonin in guiding antibiotic stewardship in lower respiratory tract infections and sepsis has been extensively studied, and use of this biomarker has been shown to decrease antibiotic usage in clinical trials. We sought to evaluate the impact of a pharmacist-driven initiative regarding discontinuation of antibiotics utilizing procalcitonin levels at a community teaching hospital.
• Methods: We retrospectively gathered baseline data on adult patients admitted to a community teaching hospital who were 18 years of age and older, under the care of an inpatient service, and had a single procalcitonin level < 0.25 mcg/L obtained during admission. We then prospectively identified an intervention group of similar patients using a web-based, real-time clinical surveillance system. When a low procalcitonin level was identified in the intervention group, the participating clinical pharmacists screened for antibiotic use and the indication(s), determined whether the antibiotic could be discontinued based on the low procalcitonin level and the absence of another indication for antibiotics, and, when appropriate, contacted the patient’s health care provider via telephone to discuss possible antibiotic discontinuation. The total antibiotic treatment duration was compared between the baseline and intervention groups.
• Results: A total of 172 patients were included in this study (86 in each group). The duration of antibiotic use was not significantly different between the baseline (3.14 ± 4.04 days) and the intervention (3.34 ± 2.8 days) groups (P = 0.1083). Other patient demographics did not influence antibiotic duration.
• Conclusion: Our study did not demonstrate a difference in total antibiotic treatment duration with the utilization of procalcitonin and an oral communication intervention made by a clinical pharmacist at a community-based teaching hospital. Outside of clinical trials, and in the absence of an algorithmic approach, procalcitonin has not consistently been shown to aid in the diagnosis and treatment of infectious diseases. It is important to have a comprehensive antimicrobial stewardship program to reduce antibiotic use and effectively use laboratory values.

Keywords: antibiotic use; bacterial infection; biomarkers; procalcitonin.

Procalcitonin is the precursor of the hormone calcitonin, which is normally produced in the parafollicular cells of the thyroid gland under physiological conditions.¹ However, procalcitonin is also released in response to a proinflammatory stimulus, especially that of bacterial origin.¹ The source of the procalcitonin surge seen during proinflammatory states is not the parafollicular cells of the thyroid, but rather the neuroendocrine cells of the lung and intestine.¹ Stimulants of procalcitonin in these scenarios include bacterial endotoxin, tumor necrosis factor, and interleukin-6.^1,2 Due to these observations, procalcitonin has emerged as an important marker of sepsis and lung infections of bacterial origin.³

The role of procalcitonin in guiding antibiotic stewardship in lower respiratory tract infections and sepsis has been extensively studied.^4,5 Various randomized controlled trials have shown that antibiotic stewardship guided by procalcitonin levels resulted in lower rates of antibiotic initiation and shorter duration of antibiotic use.^4-6 Similar results were obtained in prospective studies evaluating its role in patients with chronic obstructive pulmonary disease and sepsis.^7,8 Based on these data, protocol-driven procalcitonin-guided antibiotic stewardship appears beneficial.

Many of these studies employed rigorous protocols. Studies of procalcitonin use in a so-called real-world setting, in which the provider can order and use procalcitonin levels without the use of protocols, are limited. The objective of our study was to evaluate the impact of a pharmacist-driven initiative on discontinuing antibiotics, if indicated, utilizing single procalcitonin measurement results of < 0.25 mcg/L at a community teaching hospital.

Methods

Our study utilized a 2-phase approach. The first phase was a retrospective chart review to establish baseline data regarding adult inpatients with a low procalcitonin level; these patients were randomly selected over a 1-year period (2017). Patients were included if they were 18 years of age or older, under the care of an inpatient service, and had a single procalcitonin level < 0.25 mcg/L obtained during their admission. Patients admitted to the intensive care unit were excluded. In the second phase, we prospectively identified similar patients admitted between January and March 2018 using a web-based, real-time clinical surveillance system. When patients with low procalcitonin levels were identified, 2 participating clinical pharmacists screened for antibiotic use and indication. If it was determined that the antibiotic could be discontinued as a result of the low procalcitonin level and no additional indication for antibiotics was present, the pharmacist contacted the patient’s health care provider via telephone to discuss possible antibiotic discontinuation. Data collected before and after the intervention included total antibiotic treatment duration, white blood cell count, maximum temperature, age, and procalcitonin level.

A sample size of 86 was calculated to provide an alpha of 0.05 and a power of 0.8. A nonparametric Wilcoxon 2-sample test was used to test for a difference in duration of antibiotic treatment between the baseline and intervention groups. A nonparametric test was used due to right-skewed data. All patients were included in the group analysis, regardless of antibiotic use, as the procalcitonin level may have been used in the decision to initiate antibiotics, and this is more representative of a real-world application of the test. This allowed for detection of a significant decrease of 2 days in antibiotic duration post intervention, with a 10% margin to compensate for potential missing data. Data from 86 patients obtained prior to the pharmacist intervention acted as a control comparison group. Statistical analysis was performed using SAS 9.4.

Results

A total of 172 patients were included in this study: 86 patients prior to the intervention, and 86 after implementation. Baseline demographics, laboratory values, vitals, and principal diagnoses for both groups are shown in Table 1 and Table 2. The most common indications for procalcitonin measurement were pneumonia (45.9%), chronic obstructive pulmonary disease (15.7%), and sepsis (14.5%). The remaining diagnoses were encephalopathy, fever and leukocytosis, skin and soft tissue infection, urinary tract infection or pyelonephritis, bone and joint infection, meningitis, intra-abdominal infection, and asthma exacerbation.

Antibiotic therapy was initiated in 68% of the patients overall, 59% in the baseline group and 76% in the intervention group. The duration of antibiotic use was not significantly different between the baseline (3.14 ± 4.04 days) and intervention (3.34 ± 2.8 days) groups (P = 0.1083). Furthermore, antibiotic treatment duration did not vary significantly with patient age, white blood cell count, maximum temperature, or procalcitonin level in either group. Although there was no difference in total antibiotic treatment duration, a post-hoc analysis revealed a 0.6-day decrease in the interval between the date of procalcitonin measurement and the stop date of antibiotics in the intervention group. The average time from admission to obtaining a procalcitonin level was 3 days in the baseline group and 2 days in the intervention group.

Discussion

Our study did not demonstrate a difference in total antibiotic treatment duration with procalcitonin measurement and an oral communication intervention made by a clinical pharmacist at a community teaching hospital with a well-established antimicrobial stewardship program. This may be due to several factors. First, the providers did not receive ongoing education regarding the appropriate use or interpretation of procalcitonin. The procalcitonin result in the electronic health record references the risk for progression to severe sepsis and/or septic shock, but does not indicate how to use procalcitonin as an aid in antibiotic decision-making. However, a recent study in patients with lower respiratory tract infections treated by providers who had been educated on the use of procalcitonin failed to find a reduction in total antibiotic use.⁹ Second, our study included hospital-wide use of procalcitonin, and was not limited to infections for which procalcitonin use has the strongest evidence (eg, upper respiratory tract infections, pneumonia, sepsis). Thus, providers may have been less likely to use protocolized guidelines. Last, we did not limit the data on antibiotic duration to patients with a procalcitonin level obtained within a defined time frame from antibiotic initiation or time of admission, and some patients had procalcitonin levels measured several days into their hospital stay. While this is likely to have skewed the data in favor of longer antibiotic treatment courses, it also represents a more realistic way in which this laboratory test is being used. Our post-hoc finding of earlier discontinuation of antibiotics after procalcitonin measurement suggests that our intervention may have influenced the decision to discontinue antibiotics. Such an effect may be augmented if procalcitonin is measured earlier in a hospital admission.

Previous studies have also failed to show that the use of procalcitonin decreased duration of antibiotics.^9,10 In the aforementioned study regarding real-world outcomes in patients with lower respiratory tract infections, antibiotic duration was not reduced, despite provider education.⁹ A large observational study that evaluated real-world outcomes in intensive care unit patients did not find decreased antibiotic use or improved outcomes with procalcitonin use.¹⁰ With these large studies evaluating the 2 most common infectious diseases for which procalcitonin has previously been found to have clinical benefit, it is important for institutions to re-evaluate how procalcitonin is being utilized by providers. Furthermore, institutions should explore ways to optimize procalcitonin use and decrease unnecessary health care costs. Notably, the current community-acquired pneumonia guidelines recommend against routine use of procalcitonin.¹¹

Conclusion

Outside of clinical trials, and in the absence of an algorithmic approach, procalcitonin has not consistently been shown to aid in the diagnosis or treatment of infectious diseases. It is important to have a comprehensive antimicrobial stewardship program that includes an algorithmic protocol to promote appropriate laboratory testing and reduce total antibiotic use. In addition to improved communication with providers, other interventions need to be investigated to effectively use this biomarker or limit its use.

Acknowledgment: The authors thank the Western Michigan University Department of Epidemiology and Biostatistics for their assistance in preparing this article.

Corresponding author: James Vaillant, MD, Western Michigan University, Homer Stryker MD School of Medicine, 1000 Oakland Drive, Kalamazoo, MI, 49008; [email protected].

Financial disclosures: None.

From Western Michigan University, Homer Stryker MD School of Medicine, Kalamazoo, MI (Dr. Vaillant and Dr. Kavanaugh), Ferris State University, Grand Rapids, MI (Dr. Mersfelder), and Bronson Methodist Hospital, Kalamazoo, MI (Dr. Maynard).

Abstract

• Background: Procalcitonin has emerged as an important marker of sepsis and lung infections of bacterial origin. The role of procalcitonin in guiding antibiotic stewardship in lower respiratory tract infections and sepsis has been extensively studied, and use of this biomarker has been shown to decrease antibiotic usage in clinical trials. We sought to evaluate the impact of a pharmacist-driven initiative regarding discontinuation of antibiotics utilizing procalcitonin levels at a community teaching hospital.
• Methods: We retrospectively gathered baseline data on adult patients admitted to a community teaching hospital who were 18 years of age and older, under the care of an inpatient service, and had a single procalcitonin level < 0.25 mcg/L obtained during admission. We then prospectively identified an intervention group of similar patients using a web-based, real-time clinical surveillance system. When a low procalcitonin level was identified in the intervention group, the participating clinical pharmacists screened for antibiotic use and the indication(s), determined whether the antibiotic could be discontinued based on the low procalcitonin level and the absence of another indication for antibiotics, and, when appropriate, contacted the patient’s health care provider via telephone to discuss possible antibiotic discontinuation. The total antibiotic treatment duration was compared between the baseline and intervention groups.
• Results: A total of 172 patients were included in this study (86 in each group). The duration of antibiotic use was not significantly different between the baseline (3.14 ± 4.04 days) and the intervention (3.34 ± 2.8 days) groups (P = 0.1083). Other patient demographics did not influence antibiotic duration.
• Conclusion: Our study did not demonstrate a difference in total antibiotic treatment duration with the utilization of procalcitonin and an oral communication intervention made by a clinical pharmacist at a community-based teaching hospital. Outside of clinical trials, and in the absence of an algorithmic approach, procalcitonin has not consistently been shown to aid in the diagnosis and treatment of infectious diseases. It is important to have a comprehensive antimicrobial stewardship program to reduce antibiotic use and effectively use laboratory values.

Keywords: antibiotic use; bacterial infection; biomarkers; procalcitonin.

Procalcitonin is the precursor of the hormone calcitonin, which is normally produced in the parafollicular cells of the thyroid gland under physiological conditions.¹ However, procalcitonin is also released in response to a proinflammatory stimulus, especially that of bacterial origin.¹ The source of the procalcitonin surge seen during proinflammatory states is not the parafollicular cells of the thyroid, but rather the neuroendocrine cells of the lung and intestine.¹ Stimulants of procalcitonin in these scenarios include bacterial endotoxin, tumor necrosis factor, and interleukin-6.^1,2 Due to these observations, procalcitonin has emerged as an important marker of sepsis and lung infections of bacterial origin.³

The role of procalcitonin in guiding antibiotic stewardship in lower respiratory tract infections and sepsis has been extensively studied.^4,5 Various randomized controlled trials have shown that antibiotic stewardship guided by procalcitonin levels resulted in lower rates of antibiotic initiation and shorter duration of antibiotic use.^4-6 Similar results were obtained in prospective studies evaluating its role in patients with chronic obstructive pulmonary disease and sepsis.^7,8 Based on these data, protocol-driven procalcitonin-guided antibiotic stewardship appears beneficial.

Many of these studies employed rigorous protocols. Studies of procalcitonin use in a so-called real-world setting, in which the provider can order and use procalcitonin levels without the use of protocols, are limited. The objective of our study was to evaluate the impact of a pharmacist-driven initiative on discontinuing antibiotics, if indicated, utilizing single procalcitonin measurement results of < 0.25 mcg/L at a community teaching hospital.

Methods

Our study utilized a 2-phase approach. The first phase was a retrospective chart review to establish baseline data regarding adult inpatients with a low procalcitonin level; these patients were randomly selected over a 1-year period (2017). Patients were included if they were 18 years of age or older, under the care of an inpatient service, and had a single procalcitonin level < 0.25 mcg/L obtained during their admission. Patients admitted to the intensive care unit were excluded. In the second phase, we prospectively identified similar patients admitted between January and March 2018 using a web-based, real-time clinical surveillance system. When patients with low procalcitonin levels were identified, 2 participating clinical pharmacists screened for antibiotic use and indication. If it was determined that the antibiotic could be discontinued as a result of the low procalcitonin level and no additional indication for antibiotics was present, the pharmacist contacted the patient’s health care provider via telephone to discuss possible antibiotic discontinuation. Data collected before and after the intervention included total antibiotic treatment duration, white blood cell count, maximum temperature, age, and procalcitonin level.

A sample size of 86 was calculated to provide an alpha of 0.05 and a power of 0.8. A nonparametric Wilcoxon 2-sample test was used to test for a difference in duration of antibiotic treatment between the baseline and intervention groups. A nonparametric test was used due to right-skewed data. All patients were included in the group analysis, regardless of antibiotic use, as the procalcitonin level may have been used in the decision to initiate antibiotics, and this is more representative of a real-world application of the test. This allowed for detection of a significant decrease of 2 days in antibiotic duration post intervention, with a 10% margin to compensate for potential missing data. Data from 86 patients obtained prior to the pharmacist intervention acted as a control comparison group. Statistical analysis was performed using SAS 9.4.

Results

A total of 172 patients were included in this study: 86 patients prior to the intervention, and 86 after implementation. Baseline demographics, laboratory values, vitals, and principal diagnoses for both groups are shown in Table 1 and Table 2. The most common indications for procalcitonin measurement were pneumonia (45.9%), chronic obstructive pulmonary disease (15.7%), and sepsis (14.5%). The remaining diagnoses were encephalopathy, fever and leukocytosis, skin and soft tissue infection, urinary tract infection or pyelonephritis, bone and joint infection, meningitis, intra-abdominal infection, and asthma exacerbation.

Antibiotic therapy was initiated in 68% of the patients overall, 59% in the baseline group and 76% in the intervention group. The duration of antibiotic use was not significantly different between the baseline (3.14 ± 4.04 days) and intervention (3.34 ± 2.8 days) groups (P = 0.1083). Furthermore, antibiotic treatment duration did not vary significantly with patient age, white blood cell count, maximum temperature, or procalcitonin level in either group. Although there was no difference in total antibiotic treatment duration, a post-hoc analysis revealed a 0.6-day decrease in the interval between the date of procalcitonin measurement and the stop date of antibiotics in the intervention group. The average time from admission to obtaining a procalcitonin level was 3 days in the baseline group and 2 days in the intervention group.

Discussion

Our study did not demonstrate a difference in total antibiotic treatment duration with procalcitonin measurement and an oral communication intervention made by a clinical pharmacist at a community teaching hospital with a well-established antimicrobial stewardship program. This may be due to several factors. First, the providers did not receive ongoing education regarding the appropriate use or interpretation of procalcitonin. The procalcitonin result in the electronic health record references the risk for progression to severe sepsis and/or septic shock, but does not indicate how to use procalcitonin as an aid in antibiotic decision-making. However, a recent study in patients with lower respiratory tract infections treated by providers who had been educated on the use of procalcitonin failed to find a reduction in total antibiotic use.⁹ Second, our study included hospital-wide use of procalcitonin, and was not limited to infections for which procalcitonin use has the strongest evidence (eg, upper respiratory tract infections, pneumonia, sepsis). Thus, providers may have been less likely to use protocolized guidelines. Last, we did not limit the data on antibiotic duration to patients with a procalcitonin level obtained within a defined time frame from antibiotic initiation or time of admission, and some patients had procalcitonin levels measured several days into their hospital stay. While this is likely to have skewed the data in favor of longer antibiotic treatment courses, it also represents a more realistic way in which this laboratory test is being used. Our post-hoc finding of earlier discontinuation of antibiotics after procalcitonin measurement suggests that our intervention may have influenced the decision to discontinue antibiotics. Such an effect may be augmented if procalcitonin is measured earlier in a hospital admission.

Previous studies have also failed to show that the use of procalcitonin decreased duration of antibiotics.^9,10 In the aforementioned study regarding real-world outcomes in patients with lower respiratory tract infections, antibiotic duration was not reduced, despite provider education.⁹ A large observational study that evaluated real-world outcomes in intensive care unit patients did not find decreased antibiotic use or improved outcomes with procalcitonin use.¹⁰ With these large studies evaluating the 2 most common infectious diseases for which procalcitonin has previously been found to have clinical benefit, it is important for institutions to re-evaluate how procalcitonin is being utilized by providers. Furthermore, institutions should explore ways to optimize procalcitonin use and decrease unnecessary health care costs. Notably, the current community-acquired pneumonia guidelines recommend against routine use of procalcitonin.¹¹

Conclusion

Outside of clinical trials, and in the absence of an algorithmic approach, procalcitonin has not consistently been shown to aid in the diagnosis or treatment of infectious diseases. It is important to have a comprehensive antimicrobial stewardship program that includes an algorithmic protocol to promote appropriate laboratory testing and reduce total antibiotic use. In addition to improved communication with providers, other interventions need to be investigated to effectively use this biomarker or limit its use.

Acknowledgment: The authors thank the Western Michigan University Department of Epidemiology and Biostatistics for their assistance in preparing this article.

Corresponding author: James Vaillant, MD, Western Michigan University, Homer Stryker MD School of Medicine, 1000 Oakland Drive, Kalamazoo, MI, 49008; [email protected].

Financial disclosures: None.

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

From the University of Florida College of Medicine, Division of Infectious Diseases and Global Medicine, Gainesville, FL.

Abstract

• Objective: To review current reports on atypical manifestations of coronavirus disease 2019 (COVID-19).
• Methods: Review of the literature.
• Results: Evidence regarding atypical features of COVID-19 is accumulating. SARS-CoV-2 can infect human cells that express the angiotensin-converting enzyme 2 receptor, which would allow for a broad spectrum of illnesses affecting the renal, cardiac, and gastrointestinal organ systems. Neurologic, cutaneous, and musculoskeletal manifestations have also been reported. The potential for SARS-CoV-2 to induce a hypercoagulable state provides another avenue for the virus to indirectly damage various organ systems, as evidenced by reports of cerebrovascular disease, myocardial injury, and a chilblain-like rash in patients with COVID-19.
• Conclusion: Because the signs and symptoms of COVID-19 may occur with varying frequency across populations, it is important to keep differentials broad when assessing patients with a clinical illness that may indeed be COVID-19.

Keywords: coronavirus; severe acute respiratory syndrome coronavirus-2; SARS-CoV-2; pandemic.

Coronavirus disease 2019 (COVID-19), the syndrome caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), was first reported in Wuhan, China, in early December 2019.¹ Since then, the virus has spread quickly around the world, with the World Health Organization (WHO) declaring the coronavirus outbreak a global pandemic on March 11, 2020. As of May 21, 2020, more than 5,000,000 cases of COVID-19 have been confirmed, and more than 328,000 deaths related to COVID-19 have been reported globally.² These numbers are expected to increase, due to the reproduction number (R0) of SARS-CoV-2. R0 represents the number of new infections generated by an infectious person in a totally naïve population.³ The WHO estimates that the R0 of SARS-CoV-2 is 1.95, with other estimates ranging from 1.4 to 6.49.³ To control the pathogen, the R0 needs to be brought under a value of 1.

A fundamental tool in lowering the R0 is prompt testing and isolation of those who display signs and symptoms of infection. SARS-CoV-2 is still a novel pathogen about which we know relatively little. The common symptoms of COVID-19 are now well known—including fever, fatigue, anorexia, cough, and shortness of breath—but atypical manifestations of this viral continue to be reported and described. To help clinicians across specialties and settings identify patients with possible infection, we have summarized findings from current reports on COVID-19 manifestations involving the renal, cardiac, gastrointestinal (GI), and other organ systems.

Renal

During the 2003 SARS-CoV-1 outbreak, acute kidney injury (AKI) was an uncommon complication of the infection, but early reports suggest that AKI may occur more commonly with COVID-19.⁴ In a study of 193 patients with laboratory-confirmed COVID-19 treated in 3 Chinese hospitals, 59% presented with proteinuria, 44% with hematuria, 14% with increased blood urea nitrogen, and 10% with increased levels of serum creatinine.⁴ These markers, indicative of AKI, may be associated with increased mortality. Among this cohort, those with AKI had a mortality risk 5.3 times higher than those who did not have AKI.⁴ The pathophysiology of renal disease in COVID-19 may be related to dehydration or inflammatory mediators, causing decreased renal perfusion and cytokine storm, but evidence also suggests that SARS-CoV-2 is able to directly infect kidney cells.⁵ The virus infects cells by using angiotensin-converting enzyme 2 (ACE2) on the cell membrane as a cell entry receptor; ACE2 is expressed on the kidney, heart, and GI cells, and this may allow SARS-CoV-2 to directly infect and damage these organs. Other potential mechanisms of renal injury include overproduction of proinflammatory cytokines and administration of nephrotoxic drugs. No matter the mechanism, however, increased serum creatinine and blood urea nitrogen correlate with an increased likelihood of requiring intensive care unit (ICU) admission.⁶ Therefore, clinicians should carefully monitor renal function in patients with COVID-19.

Cardiac

In a report of 138 Chinese patients hospitalized for COVID-19, 36 required ICU admission: 44.4% of these had arrhythmias and 22.2% had developed acute cardiac injury.⁶ In addition, the cardiac cell injury biomarker troponin I was more likely to be elevated in ICU patients.⁶ A study of 21 patients admitted to the ICU in Washington State found elevated levels of brain natriuretic peptide.⁷ These biomarkers reflect the presence of myocardial stress, but do not necessarily indicate direct myocardial infection. Case reports of fulminant myocarditis in those with COVID-19 have begun to surface, however.^8,9 An examination of 68 deaths in persons with COVID-19 concluded that 7% were caused by myocarditis with circulatory failure.¹⁰

The pathophysiology of myocardial injury in COVID-19 is likely multifactorial. This includes increased inflammatory mediators, hypoxemia, and metabolic changes that can directly damage myocardial tissue. These factors can also exacerbate comorbid conditions, such as coronary artery disease, leading to ischemia and dysfunction of preexisting electrical conduction abnormalities. However, pathologic evidence of myocarditis and the presence of the ACE2 receptor, which may be a mediator of cardiac function, on cardiac muscle cells suggest that SARS-CoV-2 is capable of directly infecting and damaging myocardial cells. Other proposed mechanisms include infection-mediated downregulation of ACE2, causing cardiac dysfunction, or thrombus formation.¹¹ Although respiratory failure is the most common source of advanced illness in COVID-19 patients, myocarditis and arrhythmias can be life-threatening manifestations of the disease.

Gastrointestinal

As noted, ACE2 is expressed in the GI tract. In 73 patients hospitalized for COVID-19, 53.4% tested positive for SARS-CoV-2 RNA in stool, and 23.4% continued to have RNA-positive stool samples even after their respiratory samples tested negative.¹² These findings suggest the potential for SARS-CoV-2 to spread through fecal-oral transmission in those who are asymptomatic, pre-symptomatic, or symptomatic. This mode of transmission has yet to be determined conclusively, and more research is needed. However, GI symptoms have been reported in persons with COVID-19. Among 138 hospitalized patients, 10.1% had complaints of diarrhea and nausea and 3.6% reported vomiting.⁶ Those who reported nausea and diarrhea noted that they developed these symptoms 1 to 2 days before they developed fever.⁶ Also, among a cohort of 1099 Chinese patients with COVID-19, 3.8% complained of diarrhea.¹³ Although diarrhea does not occur in a majority of patients, GI complaints, such as nausea, vomiting, or diarrhea, should raise clinical suspicion for COVID-19, and in known areas of active transmission, testing of patients with GI symptoms is likely warranted.

Ocular

Ocular manifestations of COVID-19 are now being described, and should be taken into consideration when examining a patient. In a study of 38 patients with COVID-19 from Hubei province, China, 31.6% had ocular findings consistent with conjunctivitis, including conjunctival hyperemia, chemosis, epiphora, and increased ocular secretions.¹⁴ SARS-CoV-2 was detected in conjunctival and nasopharyngeal samples in 2 patients from this cohort. Conjunctival congestion was reported in a cohort of 1099 patients with COVID-19 treated at multiple centers throughout China, but at a much lower incidence, approximately 0.8%.¹³ Because SARS-CoV-2 can cause conjunctival disease and has been detected in samples from the external surface of the eye, it appears the virus is transmissible from tears or contact with the eye itself.

Neurologic

Common reported neurologic symptoms include dizziness, headache, impaired consciousness, ataxia, and cerebrovascular events. In a cohort of 214 patients from Wuhan, China, 36.4% had some form of neurological insult.¹⁵ These symptoms were more common in those with severe illness (P = 0.02).¹⁵ Two interesting neurologic symptoms that have been described are anosmia (loss of smell) and ageusia (loss of taste), which are being found primarily in tandem. It is still unclear how many people with COVID-19 are experiencing these symptoms, but a report from Italy estimates 19.4% of 320 patients examined had chemosensory dysfunction.¹⁶ The aforementioned report from Wuhan, China, found that 5.1% had anosmia and 5.6% had ageusia.¹⁵ The presence of anosmia/ageusia in some patients suggests that SARS-CoV-2 may enter the central nervous system (CNS) through a retrograde neuronal route.¹⁵ In addition, a case report from Japan described a 24-year-old man who presented with meningitis/encephalitis and had SARS-CoV-2 RNA present in his cerebrospinal fluid, showing that SARS-CoV-2 can penetrate into the CNS.¹⁷

SARS-CoV-2 may also have an association with Guillain–Barré syndrome, as this condition was reported in 5 patients from 3 hospitals in Northern Italy.¹⁸ The symptoms of Guillain–Barré syndrome presented 5 to 10 days after the typical COVID-19 symptoms, and evolved over 36 hours to 4 days afterwards. Four of the 5 patients experienced flaccid tetraparesis or tetraplegia, and 3 required mechanical ventilation.¹⁸

Another possible cause of neurologic injury in COVID-19 is damage to endothelial cells in cerebral blood vessels, causing thrombus formation and possibly increasing the risk of acute ischemic stroke.^15,19 Supporting this mechanism of injury, significantly lower platelet counts were noted in patients with CNS symptoms (P = 0.005).¹⁵ Other hematological impacts of COVID-19 have been reported, particularly hypercoagulability, as evidenced by elevated D-dimer levels.^13,20 This hypercoagulable state is linked to overproduction of proinflammatory cytokines (cytokine storm), leading to dysregulation of coagulation pathways and reduced concentrations of anticoagulants, such as protein C, antithrombin III, and tissue factor pathway inhibitor.²¹

Cutaneous

Cutaneous findings emerging in persons with COVID-19 demonstrate features of small-vessel and capillary occlusion, including erythematous skin eruptions and petechial rash. One report from Italy noted that 20.4% of patients with COVID-19 (n = 88) had a cutaneous finding, with a cutaneous manifestation developing in 8 at the onset of illness and in 10 following hospital admission.²² Fourteen patients had an erythematous rash, primarily on the trunk, with 3 patients having a diffuse urticarial appearing rash, and 1 patient developing vesicles.²² The severity of illness did not appear to correlate with the cutaneous manifestation, and the lesions healed within a few days.

One case report described a patient from Bangkok who was thought to be suffering from dengue fever, but was found to have SARS-CoV-2 infection. He initially presented with skin rash and petechiae, and later developed respiratory disease.²³

Other dermatologic findings of COVID-19 resemble chilblains disease, colloquially referred to as “COVID toes.” Two women, 27 and 35 years old, presented to a dermatology clinic in Qatar with a chief complaint of skin rash, described as red-purple papules on the dorsal aspects of the fingers bilaterally.²² Both patients had an unremarkable medical and drug history, but recent travel to the United Kingdom dictated SARS-CoV-2 screening, which was positive.²⁴ An Italian case report describes a 23-year-old man who tested positive for SARS-CoV-2 and had violaceous plaques on an erythematous background on his feet, without any lesions on his hands.²⁵ Since chilblains is less common in the warmer months and these events correspond with the COVID-19 pandemic, SARS-CoV-2 infection is the suspected etiology. The pathophysiology of these lesions is unclear, and more research is needed. As more data become available, we may see cutaneous manifestations in patients with COVID-19 similar to those commonly reported with other viral infectious processes.

Musculoskeletal

Of 138 patients hospitalized in Wuhan, China, for COVID-19, 34.8% presented with myalgia; the presence of myalgia does not appear to be correlated with an increased likelihood of ICU admission.⁶ Myalgia or arthralgia was also reported in 14.9% among the cohort of 1099 COVID-19 patients in China.¹³ These musculoskeletal symptoms are described among large muscle groups found in the extremities, trunk, and back, and should raise suspicion in patients who present with other signs and symptoms concerning for COVID-19.

 

 

Conclusion

Evidence regarding atypical features of COVID-19 is accumulating. SARS-CoV-2 can infect a human cells that express the ACE2 receptor, which would allow for a broad spectrum of illnesses. The potential for SARS-CoV-2 to induce a hypercoagulable state allows it to indirectly damage various organ systems,²⁰ leading to cerebrovascular disease, myocardial injury, and a chilblain-like rash. Clinicians must be aware of these unique features, as early recognition of persons who present with COVID-19 will allow for prompt testing, institution of infection control and isolation practices, and treatment, as needed, among those infected. Also, this is a pandemic involving a novel virus affecting different populations throughout the world, and these signs and symptoms may occur with varying frequency across populations. Therefore, it is important to keep differentials broad when assessing patients with a clinical illness that may indeed be COVID-19.

Corresponding author: Norman L. Beatty, MD, [email protected].

Financial disclosures: None.

From the University of Florida College of Medicine, Division of Infectious Diseases and Global Medicine, Gainesville, FL.

Abstract

• Objective: To review current reports on atypical manifestations of coronavirus disease 2019 (COVID-19).
• Methods: Review of the literature.
• Results: Evidence regarding atypical features of COVID-19 is accumulating. SARS-CoV-2 can infect human cells that express the angiotensin-converting enzyme 2 receptor, which would allow for a broad spectrum of illnesses affecting the renal, cardiac, and gastrointestinal organ systems. Neurologic, cutaneous, and musculoskeletal manifestations have also been reported. The potential for SARS-CoV-2 to induce a hypercoagulable state provides another avenue for the virus to indirectly damage various organ systems, as evidenced by reports of cerebrovascular disease, myocardial injury, and a chilblain-like rash in patients with COVID-19.
• Conclusion: Because the signs and symptoms of COVID-19 may occur with varying frequency across populations, it is important to keep differentials broad when assessing patients with a clinical illness that may indeed be COVID-19.

Keywords: coronavirus; severe acute respiratory syndrome coronavirus-2; SARS-CoV-2; pandemic.

Coronavirus disease 2019 (COVID-19), the syndrome caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), was first reported in Wuhan, China, in early December 2019.¹ Since then, the virus has spread quickly around the world, with the World Health Organization (WHO) declaring the coronavirus outbreak a global pandemic on March 11, 2020. As of May 21, 2020, more than 5,000,000 cases of COVID-19 have been confirmed, and more than 328,000 deaths related to COVID-19 have been reported globally.² These numbers are expected to increase, due to the reproduction number (R0) of SARS-CoV-2. R0 represents the number of new infections generated by an infectious person in a totally naïve population.³ The WHO estimates that the R0 of SARS-CoV-2 is 1.95, with other estimates ranging from 1.4 to 6.49.³ To control the pathogen, the R0 needs to be brought under a value of 1.

A fundamental tool in lowering the R0 is prompt testing and isolation of those who display signs and symptoms of infection. SARS-CoV-2 is still a novel pathogen about which we know relatively little. The common symptoms of COVID-19 are now well known—including fever, fatigue, anorexia, cough, and shortness of breath—but atypical manifestations of this viral continue to be reported and described. To help clinicians across specialties and settings identify patients with possible infection, we have summarized findings from current reports on COVID-19 manifestations involving the renal, cardiac, gastrointestinal (GI), and other organ systems.

Renal

During the 2003 SARS-CoV-1 outbreak, acute kidney injury (AKI) was an uncommon complication of the infection, but early reports suggest that AKI may occur more commonly with COVID-19.⁴ In a study of 193 patients with laboratory-confirmed COVID-19 treated in 3 Chinese hospitals, 59% presented with proteinuria, 44% with hematuria, 14% with increased blood urea nitrogen, and 10% with increased levels of serum creatinine.⁴ These markers, indicative of AKI, may be associated with increased mortality. Among this cohort, those with AKI had a mortality risk 5.3 times higher than those who did not have AKI.⁴ The pathophysiology of renal disease in COVID-19 may be related to dehydration or inflammatory mediators, causing decreased renal perfusion and cytokine storm, but evidence also suggests that SARS-CoV-2 is able to directly infect kidney cells.⁵ The virus infects cells by using angiotensin-converting enzyme 2 (ACE2) on the cell membrane as a cell entry receptor; ACE2 is expressed on the kidney, heart, and GI cells, and this may allow SARS-CoV-2 to directly infect and damage these organs. Other potential mechanisms of renal injury include overproduction of proinflammatory cytokines and administration of nephrotoxic drugs. No matter the mechanism, however, increased serum creatinine and blood urea nitrogen correlate with an increased likelihood of requiring intensive care unit (ICU) admission.⁶ Therefore, clinicians should carefully monitor renal function in patients with COVID-19.

Cardiac

In a report of 138 Chinese patients hospitalized for COVID-19, 36 required ICU admission: 44.4% of these had arrhythmias and 22.2% had developed acute cardiac injury.⁶ In addition, the cardiac cell injury biomarker troponin I was more likely to be elevated in ICU patients.⁶ A study of 21 patients admitted to the ICU in Washington State found elevated levels of brain natriuretic peptide.⁷ These biomarkers reflect the presence of myocardial stress, but do not necessarily indicate direct myocardial infection. Case reports of fulminant myocarditis in those with COVID-19 have begun to surface, however.^8,9 An examination of 68 deaths in persons with COVID-19 concluded that 7% were caused by myocarditis with circulatory failure.¹⁰

The pathophysiology of myocardial injury in COVID-19 is likely multifactorial. This includes increased inflammatory mediators, hypoxemia, and metabolic changes that can directly damage myocardial tissue. These factors can also exacerbate comorbid conditions, such as coronary artery disease, leading to ischemia and dysfunction of preexisting electrical conduction abnormalities. However, pathologic evidence of myocarditis and the presence of the ACE2 receptor, which may be a mediator of cardiac function, on cardiac muscle cells suggest that SARS-CoV-2 is capable of directly infecting and damaging myocardial cells. Other proposed mechanisms include infection-mediated downregulation of ACE2, causing cardiac dysfunction, or thrombus formation.¹¹ Although respiratory failure is the most common source of advanced illness in COVID-19 patients, myocarditis and arrhythmias can be life-threatening manifestations of the disease.

Gastrointestinal

As noted, ACE2 is expressed in the GI tract. In 73 patients hospitalized for COVID-19, 53.4% tested positive for SARS-CoV-2 RNA in stool, and 23.4% continued to have RNA-positive stool samples even after their respiratory samples tested negative.¹² These findings suggest the potential for SARS-CoV-2 to spread through fecal-oral transmission in those who are asymptomatic, pre-symptomatic, or symptomatic. This mode of transmission has yet to be determined conclusively, and more research is needed. However, GI symptoms have been reported in persons with COVID-19. Among 138 hospitalized patients, 10.1% had complaints of diarrhea and nausea and 3.6% reported vomiting.⁶ Those who reported nausea and diarrhea noted that they developed these symptoms 1 to 2 days before they developed fever.⁶ Also, among a cohort of 1099 Chinese patients with COVID-19, 3.8% complained of diarrhea.¹³ Although diarrhea does not occur in a majority of patients, GI complaints, such as nausea, vomiting, or diarrhea, should raise clinical suspicion for COVID-19, and in known areas of active transmission, testing of patients with GI symptoms is likely warranted.

Ocular

Ocular manifestations of COVID-19 are now being described, and should be taken into consideration when examining a patient. In a study of 38 patients with COVID-19 from Hubei province, China, 31.6% had ocular findings consistent with conjunctivitis, including conjunctival hyperemia, chemosis, epiphora, and increased ocular secretions.¹⁴ SARS-CoV-2 was detected in conjunctival and nasopharyngeal samples in 2 patients from this cohort. Conjunctival congestion was reported in a cohort of 1099 patients with COVID-19 treated at multiple centers throughout China, but at a much lower incidence, approximately 0.8%.¹³ Because SARS-CoV-2 can cause conjunctival disease and has been detected in samples from the external surface of the eye, it appears the virus is transmissible from tears or contact with the eye itself.

Neurologic

Common reported neurologic symptoms include dizziness, headache, impaired consciousness, ataxia, and cerebrovascular events. In a cohort of 214 patients from Wuhan, China, 36.4% had some form of neurological insult.¹⁵ These symptoms were more common in those with severe illness (P = 0.02).¹⁵ Two interesting neurologic symptoms that have been described are anosmia (loss of smell) and ageusia (loss of taste), which are being found primarily in tandem. It is still unclear how many people with COVID-19 are experiencing these symptoms, but a report from Italy estimates 19.4% of 320 patients examined had chemosensory dysfunction.¹⁶ The aforementioned report from Wuhan, China, found that 5.1% had anosmia and 5.6% had ageusia.¹⁵ The presence of anosmia/ageusia in some patients suggests that SARS-CoV-2 may enter the central nervous system (CNS) through a retrograde neuronal route.¹⁵ In addition, a case report from Japan described a 24-year-old man who presented with meningitis/encephalitis and had SARS-CoV-2 RNA present in his cerebrospinal fluid, showing that SARS-CoV-2 can penetrate into the CNS.¹⁷

SARS-CoV-2 may also have an association with Guillain–Barré syndrome, as this condition was reported in 5 patients from 3 hospitals in Northern Italy.¹⁸ The symptoms of Guillain–Barré syndrome presented 5 to 10 days after the typical COVID-19 symptoms, and evolved over 36 hours to 4 days afterwards. Four of the 5 patients experienced flaccid tetraparesis or tetraplegia, and 3 required mechanical ventilation.¹⁸

Another possible cause of neurologic injury in COVID-19 is damage to endothelial cells in cerebral blood vessels, causing thrombus formation and possibly increasing the risk of acute ischemic stroke.^15,19 Supporting this mechanism of injury, significantly lower platelet counts were noted in patients with CNS symptoms (P = 0.005).¹⁵ Other hematological impacts of COVID-19 have been reported, particularly hypercoagulability, as evidenced by elevated D-dimer levels.^13,20 This hypercoagulable state is linked to overproduction of proinflammatory cytokines (cytokine storm), leading to dysregulation of coagulation pathways and reduced concentrations of anticoagulants, such as protein C, antithrombin III, and tissue factor pathway inhibitor.²¹

Cutaneous

Cutaneous findings emerging in persons with COVID-19 demonstrate features of small-vessel and capillary occlusion, including erythematous skin eruptions and petechial rash. One report from Italy noted that 20.4% of patients with COVID-19 (n = 88) had a cutaneous finding, with a cutaneous manifestation developing in 8 at the onset of illness and in 10 following hospital admission.²² Fourteen patients had an erythematous rash, primarily on the trunk, with 3 patients having a diffuse urticarial appearing rash, and 1 patient developing vesicles.²² The severity of illness did not appear to correlate with the cutaneous manifestation, and the lesions healed within a few days.

One case report described a patient from Bangkok who was thought to be suffering from dengue fever, but was found to have SARS-CoV-2 infection. He initially presented with skin rash and petechiae, and later developed respiratory disease.²³

Other dermatologic findings of COVID-19 resemble chilblains disease, colloquially referred to as “COVID toes.” Two women, 27 and 35 years old, presented to a dermatology clinic in Qatar with a chief complaint of skin rash, described as red-purple papules on the dorsal aspects of the fingers bilaterally.²² Both patients had an unremarkable medical and drug history, but recent travel to the United Kingdom dictated SARS-CoV-2 screening, which was positive.²⁴ An Italian case report describes a 23-year-old man who tested positive for SARS-CoV-2 and had violaceous plaques on an erythematous background on his feet, without any lesions on his hands.²⁵ Since chilblains is less common in the warmer months and these events correspond with the COVID-19 pandemic, SARS-CoV-2 infection is the suspected etiology. The pathophysiology of these lesions is unclear, and more research is needed. As more data become available, we may see cutaneous manifestations in patients with COVID-19 similar to those commonly reported with other viral infectious processes.

Musculoskeletal

Of 138 patients hospitalized in Wuhan, China, for COVID-19, 34.8% presented with myalgia; the presence of myalgia does not appear to be correlated with an increased likelihood of ICU admission.⁶ Myalgia or arthralgia was also reported in 14.9% among the cohort of 1099 COVID-19 patients in China.¹³ These musculoskeletal symptoms are described among large muscle groups found in the extremities, trunk, and back, and should raise suspicion in patients who present with other signs and symptoms concerning for COVID-19.

 

 

Conclusion

Evidence regarding atypical features of COVID-19 is accumulating. SARS-CoV-2 can infect a human cells that express the ACE2 receptor, which would allow for a broad spectrum of illnesses. The potential for SARS-CoV-2 to induce a hypercoagulable state allows it to indirectly damage various organ systems,²⁰ leading to cerebrovascular disease, myocardial injury, and a chilblain-like rash. Clinicians must be aware of these unique features, as early recognition of persons who present with COVID-19 will allow for prompt testing, institution of infection control and isolation practices, and treatment, as needed, among those infected. Also, this is a pandemic involving a novel virus affecting different populations throughout the world, and these signs and symptoms may occur with varying frequency across populations. Therefore, it is important to keep differentials broad when assessing patients with a clinical illness that may indeed be COVID-19.

Corresponding author: Norman L. Beatty, MD, [email protected].

Financial disclosures: None.

From the University of Florida College of Medicine, Division of Infectious Diseases and Global Medicine, Gainesville, FL.

Abstract

• Objective: To review current reports on atypical manifestations of coronavirus disease 2019 (COVID-19).
• Methods: Review of the literature.
• Results: Evidence regarding atypical features of COVID-19 is accumulating. SARS-CoV-2 can infect human cells that express the angiotensin-converting enzyme 2 receptor, which would allow for a broad spectrum of illnesses affecting the renal, cardiac, and gastrointestinal organ systems. Neurologic, cutaneous, and musculoskeletal manifestations have also been reported. The potential for SARS-CoV-2 to induce a hypercoagulable state provides another avenue for the virus to indirectly damage various organ systems, as evidenced by reports of cerebrovascular disease, myocardial injury, and a chilblain-like rash in patients with COVID-19.
• Conclusion: Because the signs and symptoms of COVID-19 may occur with varying frequency across populations, it is important to keep differentials broad when assessing patients with a clinical illness that may indeed be COVID-19.

Keywords: coronavirus; severe acute respiratory syndrome coronavirus-2; SARS-CoV-2; pandemic.

Coronavirus disease 2019 (COVID-19), the syndrome caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), was first reported in Wuhan, China, in early December 2019.¹ Since then, the virus has spread quickly around the world, with the World Health Organization (WHO) declaring the coronavirus outbreak a global pandemic on March 11, 2020. As of May 21, 2020, more than 5,000,000 cases of COVID-19 have been confirmed, and more than 328,000 deaths related to COVID-19 have been reported globally.² These numbers are expected to increase, due to the reproduction number (R0) of SARS-CoV-2. R0 represents the number of new infections generated by an infectious person in a totally naïve population.³ The WHO estimates that the R0 of SARS-CoV-2 is 1.95, with other estimates ranging from 1.4 to 6.49.³ To control the pathogen, the R0 needs to be brought under a value of 1.

A fundamental tool in lowering the R0 is prompt testing and isolation of those who display signs and symptoms of infection. SARS-CoV-2 is still a novel pathogen about which we know relatively little. The common symptoms of COVID-19 are now well known—including fever, fatigue, anorexia, cough, and shortness of breath—but atypical manifestations of this viral continue to be reported and described. To help clinicians across specialties and settings identify patients with possible infection, we have summarized findings from current reports on COVID-19 manifestations involving the renal, cardiac, gastrointestinal (GI), and other organ systems.

Renal

During the 2003 SARS-CoV-1 outbreak, acute kidney injury (AKI) was an uncommon complication of the infection, but early reports suggest that AKI may occur more commonly with COVID-19.⁴ In a study of 193 patients with laboratory-confirmed COVID-19 treated in 3 Chinese hospitals, 59% presented with proteinuria, 44% with hematuria, 14% with increased blood urea nitrogen, and 10% with increased levels of serum creatinine.⁴ These markers, indicative of AKI, may be associated with increased mortality. Among this cohort, those with AKI had a mortality risk 5.3 times higher than those who did not have AKI.⁴ The pathophysiology of renal disease in COVID-19 may be related to dehydration or inflammatory mediators, causing decreased renal perfusion and cytokine storm, but evidence also suggests that SARS-CoV-2 is able to directly infect kidney cells.⁵ The virus infects cells by using angiotensin-converting enzyme 2 (ACE2) on the cell membrane as a cell entry receptor; ACE2 is expressed on the kidney, heart, and GI cells, and this may allow SARS-CoV-2 to directly infect and damage these organs. Other potential mechanisms of renal injury include overproduction of proinflammatory cytokines and administration of nephrotoxic drugs. No matter the mechanism, however, increased serum creatinine and blood urea nitrogen correlate with an increased likelihood of requiring intensive care unit (ICU) admission.⁶ Therefore, clinicians should carefully monitor renal function in patients with COVID-19.

Cardiac

In a report of 138 Chinese patients hospitalized for COVID-19, 36 required ICU admission: 44.4% of these had arrhythmias and 22.2% had developed acute cardiac injury.⁶ In addition, the cardiac cell injury biomarker troponin I was more likely to be elevated in ICU patients.⁶ A study of 21 patients admitted to the ICU in Washington State found elevated levels of brain natriuretic peptide.⁷ These biomarkers reflect the presence of myocardial stress, but do not necessarily indicate direct myocardial infection. Case reports of fulminant myocarditis in those with COVID-19 have begun to surface, however.^8,9 An examination of 68 deaths in persons with COVID-19 concluded that 7% were caused by myocarditis with circulatory failure.¹⁰

The pathophysiology of myocardial injury in COVID-19 is likely multifactorial. This includes increased inflammatory mediators, hypoxemia, and metabolic changes that can directly damage myocardial tissue. These factors can also exacerbate comorbid conditions, such as coronary artery disease, leading to ischemia and dysfunction of preexisting electrical conduction abnormalities. However, pathologic evidence of myocarditis and the presence of the ACE2 receptor, which may be a mediator of cardiac function, on cardiac muscle cells suggest that SARS-CoV-2 is capable of directly infecting and damaging myocardial cells. Other proposed mechanisms include infection-mediated downregulation of ACE2, causing cardiac dysfunction, or thrombus formation.¹¹ Although respiratory failure is the most common source of advanced illness in COVID-19 patients, myocarditis and arrhythmias can be life-threatening manifestations of the disease.

Gastrointestinal

As noted, ACE2 is expressed in the GI tract. In 73 patients hospitalized for COVID-19, 53.4% tested positive for SARS-CoV-2 RNA in stool, and 23.4% continued to have RNA-positive stool samples even after their respiratory samples tested negative.¹² These findings suggest the potential for SARS-CoV-2 to spread through fecal-oral transmission in those who are asymptomatic, pre-symptomatic, or symptomatic. This mode of transmission has yet to be determined conclusively, and more research is needed. However, GI symptoms have been reported in persons with COVID-19. Among 138 hospitalized patients, 10.1% had complaints of diarrhea and nausea and 3.6% reported vomiting.⁶ Those who reported nausea and diarrhea noted that they developed these symptoms 1 to 2 days before they developed fever.⁶ Also, among a cohort of 1099 Chinese patients with COVID-19, 3.8% complained of diarrhea.¹³ Although diarrhea does not occur in a majority of patients, GI complaints, such as nausea, vomiting, or diarrhea, should raise clinical suspicion for COVID-19, and in known areas of active transmission, testing of patients with GI symptoms is likely warranted.

Ocular

Ocular manifestations of COVID-19 are now being described, and should be taken into consideration when examining a patient. In a study of 38 patients with COVID-19 from Hubei province, China, 31.6% had ocular findings consistent with conjunctivitis, including conjunctival hyperemia, chemosis, epiphora, and increased ocular secretions.¹⁴ SARS-CoV-2 was detected in conjunctival and nasopharyngeal samples in 2 patients from this cohort. Conjunctival congestion was reported in a cohort of 1099 patients with COVID-19 treated at multiple centers throughout China, but at a much lower incidence, approximately 0.8%.¹³ Because SARS-CoV-2 can cause conjunctival disease and has been detected in samples from the external surface of the eye, it appears the virus is transmissible from tears or contact with the eye itself.

Neurologic

Common reported neurologic symptoms include dizziness, headache, impaired consciousness, ataxia, and cerebrovascular events. In a cohort of 214 patients from Wuhan, China, 36.4% had some form of neurological insult.¹⁵ These symptoms were more common in those with severe illness (P = 0.02).¹⁵ Two interesting neurologic symptoms that have been described are anosmia (loss of smell) and ageusia (loss of taste), which are being found primarily in tandem. It is still unclear how many people with COVID-19 are experiencing these symptoms, but a report from Italy estimates 19.4% of 320 patients examined had chemosensory dysfunction.¹⁶ The aforementioned report from Wuhan, China, found that 5.1% had anosmia and 5.6% had ageusia.¹⁵ The presence of anosmia/ageusia in some patients suggests that SARS-CoV-2 may enter the central nervous system (CNS) through a retrograde neuronal route.¹⁵ In addition, a case report from Japan described a 24-year-old man who presented with meningitis/encephalitis and had SARS-CoV-2 RNA present in his cerebrospinal fluid, showing that SARS-CoV-2 can penetrate into the CNS.¹⁷

SARS-CoV-2 may also have an association with Guillain–Barré syndrome, as this condition was reported in 5 patients from 3 hospitals in Northern Italy.¹⁸ The symptoms of Guillain–Barré syndrome presented 5 to 10 days after the typical COVID-19 symptoms, and evolved over 36 hours to 4 days afterwards. Four of the 5 patients experienced flaccid tetraparesis or tetraplegia, and 3 required mechanical ventilation.¹⁸

Another possible cause of neurologic injury in COVID-19 is damage to endothelial cells in cerebral blood vessels, causing thrombus formation and possibly increasing the risk of acute ischemic stroke.^15,19 Supporting this mechanism of injury, significantly lower platelet counts were noted in patients with CNS symptoms (P = 0.005).¹⁵ Other hematological impacts of COVID-19 have been reported, particularly hypercoagulability, as evidenced by elevated D-dimer levels.^13,20 This hypercoagulable state is linked to overproduction of proinflammatory cytokines (cytokine storm), leading to dysregulation of coagulation pathways and reduced concentrations of anticoagulants, such as protein C, antithrombin III, and tissue factor pathway inhibitor.²¹

Cutaneous

Cutaneous findings emerging in persons with COVID-19 demonstrate features of small-vessel and capillary occlusion, including erythematous skin eruptions and petechial rash. One report from Italy noted that 20.4% of patients with COVID-19 (n = 88) had a cutaneous finding, with a cutaneous manifestation developing in 8 at the onset of illness and in 10 following hospital admission.²² Fourteen patients had an erythematous rash, primarily on the trunk, with 3 patients having a diffuse urticarial appearing rash, and 1 patient developing vesicles.²² The severity of illness did not appear to correlate with the cutaneous manifestation, and the lesions healed within a few days.

One case report described a patient from Bangkok who was thought to be suffering from dengue fever, but was found to have SARS-CoV-2 infection. He initially presented with skin rash and petechiae, and later developed respiratory disease.²³

Other dermatologic findings of COVID-19 resemble chilblains disease, colloquially referred to as “COVID toes.” Two women, 27 and 35 years old, presented to a dermatology clinic in Qatar with a chief complaint of skin rash, described as red-purple papules on the dorsal aspects of the fingers bilaterally.²² Both patients had an unremarkable medical and drug history, but recent travel to the United Kingdom dictated SARS-CoV-2 screening, which was positive.²⁴ An Italian case report describes a 23-year-old man who tested positive for SARS-CoV-2 and had violaceous plaques on an erythematous background on his feet, without any lesions on his hands.²⁵ Since chilblains is less common in the warmer months and these events correspond with the COVID-19 pandemic, SARS-CoV-2 infection is the suspected etiology. The pathophysiology of these lesions is unclear, and more research is needed. As more data become available, we may see cutaneous manifestations in patients with COVID-19 similar to those commonly reported with other viral infectious processes.

Musculoskeletal

Of 138 patients hospitalized in Wuhan, China, for COVID-19, 34.8% presented with myalgia; the presence of myalgia does not appear to be correlated with an increased likelihood of ICU admission.⁶ Myalgia or arthralgia was also reported in 14.9% among the cohort of 1099 COVID-19 patients in China.¹³ These musculoskeletal symptoms are described among large muscle groups found in the extremities, trunk, and back, and should raise suspicion in patients who present with other signs and symptoms concerning for COVID-19.

 

 

Conclusion

Evidence regarding atypical features of COVID-19 is accumulating. SARS-CoV-2 can infect a human cells that express the ACE2 receptor, which would allow for a broad spectrum of illnesses. The potential for SARS-CoV-2 to induce a hypercoagulable state allows it to indirectly damage various organ systems,²⁰ leading to cerebrovascular disease, myocardial injury, and a chilblain-like rash. Clinicians must be aware of these unique features, as early recognition of persons who present with COVID-19 will allow for prompt testing, institution of infection control and isolation practices, and treatment, as needed, among those infected. Also, this is a pandemic involving a novel virus affecting different populations throughout the world, and these signs and symptoms may occur with varying frequency across populations. Therefore, it is important to keep differentials broad when assessing patients with a clinical illness that may indeed be COVID-19.

Corresponding author: Norman L. Beatty, MD, [email protected].

Financial disclosures: None.

Study Overview

Objective. To assess the efficacy, safety, and clinical benefit of remdesivir in hospitalized adults with confirmed pneumonia due to severe SARS-CoV-2 infection.

Design. Randomized, investigator-initiated, placebo-controlled, double-blind, multicenter trial.

Setting and participants. The trial took place between February 6, 2020 and March 12, 2020, at 10 hospitals in Wuhan, China. Study participants included adult patients (aged ≥ 18 years) admitted to hospital who tested positive for SARS-CoV-2 by reverse transcription polymerase chain reaction assay and had the following clinical characteristics: radiographic evidence of pneumonia; hypoxia with oxygen saturation ≤ 94% on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤ 300 mm Hg; and symptom onset to enrollment ≤ 12 days. Some of the exclusion criteria for participation in the study were pregnancy or breast feeding, liver cirrhosis, abnormal liver enzymes ≥ 5 times the upper limit of normal, severe renal impairment or receipt of renal replacement therapy, plan for transfer to a non-study hospital, and enrollment in a trial for COVID-19 within the previous month.

Intervention. Participants were randomized in a 2:1 ratio to the remdesivir group or the placebo group and were administered either intravenous infusions of remdesivir (200 mg on day 1 followed by 100 mg daily on days 2-10) or the same volume of placebo for 10 days. Clinical and safety data assessed included laboratory testing, electrocardiogram, and medication adverse effects. Testing of oropharyngeal and nasopharyngeal swab samples, anal swab samples, sputum, and stool was performed for viral RNA detection and quantification on days 1, 3, 5, 7, 10, 14, 21, and 28.

Main outcome measures. The primary endpoint of this study was time to clinical improvement within 28 days after randomization. Clinical improvement was defined as a 2-point reduction in participants’ admission status on a 6-point ordinal scale (1 = discharged or clinical recovery, 6 = death) or live discharge from hospital, whichever came first. Secondary outcomes included all-cause mortality at day 28 and duration of hospital admission, oxygen support, and invasive mechanical ventilation. Virological measures and safety outcomes ascertained included treatment-emergent adverse events, serious adverse events, and premature discontinuation of remdesivir.

The sample size estimate for the original study design was a total of 453 patients (302 in the remdesivir group and 151 in the placebo group). This sample size would provide 80% power, assuming a hazard ratio (HR) of 1.4 comparing remdesivir to placebo, and corresponding to a change in time to clinical improvement of 6 days. The analysis of primary outcome was performed on an intention-to-treat basis. Time to clinical improvement within 28 days was assessed with Kaplan-Meier plots.

Main results. A total of 255 patients were screened, of whom 237 were enrolled and randomized to remdesivir (158) or placebo (79) group. Of the participants in the remdesivir group, 155 started study treatment and 150 completed treatment per protocol. For the participants in the placebo group, 78 started study treatment and 76 completed treatment per-protocol. Study enrollment was terminated after March 12, 2020, before attaining the prespecified sample size, because no additional patients met study eligibility criteria due to various public health measures implemented in Wuhan. The median age of participants was 65 years (IQR, 56-71), the majority were men (56% in remdesivir group vs 65% in placebo group), and the most common comorbidities included hypertension, diabetes, and coronary artery disease. Median time from symptom onset to study enrollment was 10 days (IQR, 9-12). The time to clinical improvement between treatments (21 days for remdesivir group vs 23 days for placebo group) was not significantly different (HR, 1.23; 95% confidence interval [CI], 0.87-1.75). In addition, in participants who received treatment within 10 days of symptom onset, those who were administered remdesivir had a nonsignificant (HR, 1.52; 95% CI, 0.95-2.43) but faster time (18 days) to clinical improvement, compared to those administered placebo (23 days). Moreover, treatment with remdesivir versus placebo did not lead to differences in secondary outcomes (eg, 28-day mortality and duration of hospital stay, oxygen support, and invasive mechanical ventilation), changes in viral load over time, or adverse events between the groups.

Conclusion. This study found that, compared with placebo, intravenous remdesivir did not significantly improve the time to clinical improvement, mortality, or time to clearance of SARS-CoV-2 in hospitalized adults with severe COVID-19. A numeric reduction in time to clinical improvement with early remdesivir treatment (ie, within 10 days of symptom onset) that approached statistical significance was observed in this underpowered study.

Commentary

Within a few short months since its emergence. SARS-CoV-2 infection has caused a global pandemic, posing a dire threat to public health due to its adverse effects on morbidity (eg, respiratory failure, thromboembolic diseases, multiorgan failure) and mortality. To date, no pharmacologic treatment has been shown to effectively improve clinical outcomes in patients with COVID-19. Multiple ongoing clinical trials are being conducted globally to determine potential therapeutic treatments for severe COVID-19. The first clinical trials of hydroxychloroquine and lopinavir-ritonavir, agents traditionally used for other indications, such as malaria and HIV, did not show a clear benefit in COVID-19.^1,2 Remdesivir, a nucleoside analogue prodrug, is a broad-spectrum antiviral agent that was previously used for treatment of Ebola and has been shown to have inhibitory effects on pathogenic coronaviruses. The study reported by Wang and colleagues was the first randomized controlled trial (RCT) aimed at evaluating whether remdesivir improves outcomes in patients with severe COVID-19. Thus, the worsening COVID-19 pandemic, coupled with the absence of a curative treatment, underscore the urgency of this trial.

The study was grounded on observational data from several recent case reports and case series centering on the potential efficacy of remdesivir in treating COVID-19.³ The study itself was designed well (ie, randomized, placebo-controlled, double-blind, multicenter) and carefully implemented (ie, high protocol adherence to treatments, no loss to follow-up). The principal limitation of this study was its inability to reach the estimated statistical power of study. Due to successful epidemic control in Wuhan, which led to marked reductions in hospital admission of patients with COVID-19, and implementation of stringent termination criteria per the study protocol, only 237 participants were enrolled, instead of the 453, as specified by the sample estimate. This corresponded to a reduction of statistical power from 80% to 58%. Due to this limitation, the study was underpowered, rendering its findings inconclusive.

Despite this limitation, the study found that those treated with remdesivir within 10 days of symptom onset had a numerically faster time (although not statistically significant) to clinical improvement. This leads to an interesting question: whether remdesivir administration early in COVID-19 course could improve clinical outcomes, a question that warrants further investigation by an adequately powered trial. Also, data from this study provided evidence that intravenous remdesivir administration is likely safe in adults during the treatment period, although the long-term drug effects, as well as the safety profile in pediatric patients, remain unknown at this time.

While the study reported by Wang and colleagues was underpowered and is thus inconclusive, several other ongoing RCTs are evaluating the potential clinical benefit of remdesivir treatment in patients hospitalized with COVID-19. On the date of online publication of this report in The Lancet, the National Institutes of Health (NIH) published a news release summarizing preliminary findings from the Adaptive COVID-19 Treatment Trial (ACTT), which showed positive effects of remdesivir on clinical recovery from advanced COVID-19.⁴ The ACTT, the first RCT launched in the United States to evaluate experimental treatment for COVID-19, included 1063 hospitalized participants with advanced COVID-19 and lung involvement. Participants who were administered remdesivir had a 31% faster time to recovery compared to those in the placebo group (median time to recovery, 11 days vs 15 days, respectively; P < 0.001), and had near statistically significant improved survival (mortality rate, 8.0% vs 11.6%, respectively; P = 0.059). In response to these findings, the US Food and Drug Administration (FDA) issued an emergency use authorization for remdesivir on May 1, 2020, for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.⁵ While the findings noted from the NIH news release are very encouraging and provide the first evidence of a potentially beneficial antiviral treatment for severe COVID-19 in humans, the scientific community awaits the peer-reviewed publication of the ACTT to better assess the safety and effectiveness of remdesivir therapy and determine the trial’s implications in the management of COVID-19.

 

 

Applications for Clinical Practice

The discovery of an effective pharmacologic intervention for COVID-19 is of utmost urgency. While the present study was unable to answer the question of whether remdesivir is effective in improving clinical outcomes in patients with severe COVID-19, other ongoing or completed (ie, ACTT) studies will likely address this knowledge gap in the coming months. The FDA’s emergency use authorization for remdesivir provides a glimpse into this possibility.

–Katerina Oikonomou, MD, Brookdale Department of Geriatrics & Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY

–Fred Ko, MD

Study Overview

Objective. To assess the efficacy, safety, and clinical benefit of remdesivir in hospitalized adults with confirmed pneumonia due to severe SARS-CoV-2 infection.

Design. Randomized, investigator-initiated, placebo-controlled, double-blind, multicenter trial.

Setting and participants. The trial took place between February 6, 2020 and March 12, 2020, at 10 hospitals in Wuhan, China. Study participants included adult patients (aged ≥ 18 years) admitted to hospital who tested positive for SARS-CoV-2 by reverse transcription polymerase chain reaction assay and had the following clinical characteristics: radiographic evidence of pneumonia; hypoxia with oxygen saturation ≤ 94% on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤ 300 mm Hg; and symptom onset to enrollment ≤ 12 days. Some of the exclusion criteria for participation in the study were pregnancy or breast feeding, liver cirrhosis, abnormal liver enzymes ≥ 5 times the upper limit of normal, severe renal impairment or receipt of renal replacement therapy, plan for transfer to a non-study hospital, and enrollment in a trial for COVID-19 within the previous month.

Intervention. Participants were randomized in a 2:1 ratio to the remdesivir group or the placebo group and were administered either intravenous infusions of remdesivir (200 mg on day 1 followed by 100 mg daily on days 2-10) or the same volume of placebo for 10 days. Clinical and safety data assessed included laboratory testing, electrocardiogram, and medication adverse effects. Testing of oropharyngeal and nasopharyngeal swab samples, anal swab samples, sputum, and stool was performed for viral RNA detection and quantification on days 1, 3, 5, 7, 10, 14, 21, and 28.

Main outcome measures. The primary endpoint of this study was time to clinical improvement within 28 days after randomization. Clinical improvement was defined as a 2-point reduction in participants’ admission status on a 6-point ordinal scale (1 = discharged or clinical recovery, 6 = death) or live discharge from hospital, whichever came first. Secondary outcomes included all-cause mortality at day 28 and duration of hospital admission, oxygen support, and invasive mechanical ventilation. Virological measures and safety outcomes ascertained included treatment-emergent adverse events, serious adverse events, and premature discontinuation of remdesivir.

The sample size estimate for the original study design was a total of 453 patients (302 in the remdesivir group and 151 in the placebo group). This sample size would provide 80% power, assuming a hazard ratio (HR) of 1.4 comparing remdesivir to placebo, and corresponding to a change in time to clinical improvement of 6 days. The analysis of primary outcome was performed on an intention-to-treat basis. Time to clinical improvement within 28 days was assessed with Kaplan-Meier plots.

Main results. A total of 255 patients were screened, of whom 237 were enrolled and randomized to remdesivir (158) or placebo (79) group. Of the participants in the remdesivir group, 155 started study treatment and 150 completed treatment per protocol. For the participants in the placebo group, 78 started study treatment and 76 completed treatment per-protocol. Study enrollment was terminated after March 12, 2020, before attaining the prespecified sample size, because no additional patients met study eligibility criteria due to various public health measures implemented in Wuhan. The median age of participants was 65 years (IQR, 56-71), the majority were men (56% in remdesivir group vs 65% in placebo group), and the most common comorbidities included hypertension, diabetes, and coronary artery disease. Median time from symptom onset to study enrollment was 10 days (IQR, 9-12). The time to clinical improvement between treatments (21 days for remdesivir group vs 23 days for placebo group) was not significantly different (HR, 1.23; 95% confidence interval [CI], 0.87-1.75). In addition, in participants who received treatment within 10 days of symptom onset, those who were administered remdesivir had a nonsignificant (HR, 1.52; 95% CI, 0.95-2.43) but faster time (18 days) to clinical improvement, compared to those administered placebo (23 days). Moreover, treatment with remdesivir versus placebo did not lead to differences in secondary outcomes (eg, 28-day mortality and duration of hospital stay, oxygen support, and invasive mechanical ventilation), changes in viral load over time, or adverse events between the groups.

Conclusion. This study found that, compared with placebo, intravenous remdesivir did not significantly improve the time to clinical improvement, mortality, or time to clearance of SARS-CoV-2 in hospitalized adults with severe COVID-19. A numeric reduction in time to clinical improvement with early remdesivir treatment (ie, within 10 days of symptom onset) that approached statistical significance was observed in this underpowered study.

Commentary

Within a few short months since its emergence. SARS-CoV-2 infection has caused a global pandemic, posing a dire threat to public health due to its adverse effects on morbidity (eg, respiratory failure, thromboembolic diseases, multiorgan failure) and mortality. To date, no pharmacologic treatment has been shown to effectively improve clinical outcomes in patients with COVID-19. Multiple ongoing clinical trials are being conducted globally to determine potential therapeutic treatments for severe COVID-19. The first clinical trials of hydroxychloroquine and lopinavir-ritonavir, agents traditionally used for other indications, such as malaria and HIV, did not show a clear benefit in COVID-19.^1,2 Remdesivir, a nucleoside analogue prodrug, is a broad-spectrum antiviral agent that was previously used for treatment of Ebola and has been shown to have inhibitory effects on pathogenic coronaviruses. The study reported by Wang and colleagues was the first randomized controlled trial (RCT) aimed at evaluating whether remdesivir improves outcomes in patients with severe COVID-19. Thus, the worsening COVID-19 pandemic, coupled with the absence of a curative treatment, underscore the urgency of this trial.

The study was grounded on observational data from several recent case reports and case series centering on the potential efficacy of remdesivir in treating COVID-19.³ The study itself was designed well (ie, randomized, placebo-controlled, double-blind, multicenter) and carefully implemented (ie, high protocol adherence to treatments, no loss to follow-up). The principal limitation of this study was its inability to reach the estimated statistical power of study. Due to successful epidemic control in Wuhan, which led to marked reductions in hospital admission of patients with COVID-19, and implementation of stringent termination criteria per the study protocol, only 237 participants were enrolled, instead of the 453, as specified by the sample estimate. This corresponded to a reduction of statistical power from 80% to 58%. Due to this limitation, the study was underpowered, rendering its findings inconclusive.

Despite this limitation, the study found that those treated with remdesivir within 10 days of symptom onset had a numerically faster time (although not statistically significant) to clinical improvement. This leads to an interesting question: whether remdesivir administration early in COVID-19 course could improve clinical outcomes, a question that warrants further investigation by an adequately powered trial. Also, data from this study provided evidence that intravenous remdesivir administration is likely safe in adults during the treatment period, although the long-term drug effects, as well as the safety profile in pediatric patients, remain unknown at this time.

While the study reported by Wang and colleagues was underpowered and is thus inconclusive, several other ongoing RCTs are evaluating the potential clinical benefit of remdesivir treatment in patients hospitalized with COVID-19. On the date of online publication of this report in The Lancet, the National Institutes of Health (NIH) published a news release summarizing preliminary findings from the Adaptive COVID-19 Treatment Trial (ACTT), which showed positive effects of remdesivir on clinical recovery from advanced COVID-19.⁴ The ACTT, the first RCT launched in the United States to evaluate experimental treatment for COVID-19, included 1063 hospitalized participants with advanced COVID-19 and lung involvement. Participants who were administered remdesivir had a 31% faster time to recovery compared to those in the placebo group (median time to recovery, 11 days vs 15 days, respectively; P < 0.001), and had near statistically significant improved survival (mortality rate, 8.0% vs 11.6%, respectively; P = 0.059). In response to these findings, the US Food and Drug Administration (FDA) issued an emergency use authorization for remdesivir on May 1, 2020, for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.⁵ While the findings noted from the NIH news release are very encouraging and provide the first evidence of a potentially beneficial antiviral treatment for severe COVID-19 in humans, the scientific community awaits the peer-reviewed publication of the ACTT to better assess the safety and effectiveness of remdesivir therapy and determine the trial’s implications in the management of COVID-19.

 

 

Applications for Clinical Practice

The discovery of an effective pharmacologic intervention for COVID-19 is of utmost urgency. While the present study was unable to answer the question of whether remdesivir is effective in improving clinical outcomes in patients with severe COVID-19, other ongoing or completed (ie, ACTT) studies will likely address this knowledge gap in the coming months. The FDA’s emergency use authorization for remdesivir provides a glimpse into this possibility.

–Katerina Oikonomou, MD, Brookdale Department of Geriatrics & Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY

–Fred Ko, MD

Study Overview

Objective. To assess the efficacy, safety, and clinical benefit of remdesivir in hospitalized adults with confirmed pneumonia due to severe SARS-CoV-2 infection.

Design. Randomized, investigator-initiated, placebo-controlled, double-blind, multicenter trial.

Setting and participants. The trial took place between February 6, 2020 and March 12, 2020, at 10 hospitals in Wuhan, China. Study participants included adult patients (aged ≥ 18 years) admitted to hospital who tested positive for SARS-CoV-2 by reverse transcription polymerase chain reaction assay and had the following clinical characteristics: radiographic evidence of pneumonia; hypoxia with oxygen saturation ≤ 94% on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤ 300 mm Hg; and symptom onset to enrollment ≤ 12 days. Some of the exclusion criteria for participation in the study were pregnancy or breast feeding, liver cirrhosis, abnormal liver enzymes ≥ 5 times the upper limit of normal, severe renal impairment or receipt of renal replacement therapy, plan for transfer to a non-study hospital, and enrollment in a trial for COVID-19 within the previous month.

Intervention. Participants were randomized in a 2:1 ratio to the remdesivir group or the placebo group and were administered either intravenous infusions of remdesivir (200 mg on day 1 followed by 100 mg daily on days 2-10) or the same volume of placebo for 10 days. Clinical and safety data assessed included laboratory testing, electrocardiogram, and medication adverse effects. Testing of oropharyngeal and nasopharyngeal swab samples, anal swab samples, sputum, and stool was performed for viral RNA detection and quantification on days 1, 3, 5, 7, 10, 14, 21, and 28.

Main outcome measures. The primary endpoint of this study was time to clinical improvement within 28 days after randomization. Clinical improvement was defined as a 2-point reduction in participants’ admission status on a 6-point ordinal scale (1 = discharged or clinical recovery, 6 = death) or live discharge from hospital, whichever came first. Secondary outcomes included all-cause mortality at day 28 and duration of hospital admission, oxygen support, and invasive mechanical ventilation. Virological measures and safety outcomes ascertained included treatment-emergent adverse events, serious adverse events, and premature discontinuation of remdesivir.

The sample size estimate for the original study design was a total of 453 patients (302 in the remdesivir group and 151 in the placebo group). This sample size would provide 80% power, assuming a hazard ratio (HR) of 1.4 comparing remdesivir to placebo, and corresponding to a change in time to clinical improvement of 6 days. The analysis of primary outcome was performed on an intention-to-treat basis. Time to clinical improvement within 28 days was assessed with Kaplan-Meier plots.

Main results. A total of 255 patients were screened, of whom 237 were enrolled and randomized to remdesivir (158) or placebo (79) group. Of the participants in the remdesivir group, 155 started study treatment and 150 completed treatment per protocol. For the participants in the placebo group, 78 started study treatment and 76 completed treatment per-protocol. Study enrollment was terminated after March 12, 2020, before attaining the prespecified sample size, because no additional patients met study eligibility criteria due to various public health measures implemented in Wuhan. The median age of participants was 65 years (IQR, 56-71), the majority were men (56% in remdesivir group vs 65% in placebo group), and the most common comorbidities included hypertension, diabetes, and coronary artery disease. Median time from symptom onset to study enrollment was 10 days (IQR, 9-12). The time to clinical improvement between treatments (21 days for remdesivir group vs 23 days for placebo group) was not significantly different (HR, 1.23; 95% confidence interval [CI], 0.87-1.75). In addition, in participants who received treatment within 10 days of symptom onset, those who were administered remdesivir had a nonsignificant (HR, 1.52; 95% CI, 0.95-2.43) but faster time (18 days) to clinical improvement, compared to those administered placebo (23 days). Moreover, treatment with remdesivir versus placebo did not lead to differences in secondary outcomes (eg, 28-day mortality and duration of hospital stay, oxygen support, and invasive mechanical ventilation), changes in viral load over time, or adverse events between the groups.

Conclusion. This study found that, compared with placebo, intravenous remdesivir did not significantly improve the time to clinical improvement, mortality, or time to clearance of SARS-CoV-2 in hospitalized adults with severe COVID-19. A numeric reduction in time to clinical improvement with early remdesivir treatment (ie, within 10 days of symptom onset) that approached statistical significance was observed in this underpowered study.

Commentary

Within a few short months since its emergence. SARS-CoV-2 infection has caused a global pandemic, posing a dire threat to public health due to its adverse effects on morbidity (eg, respiratory failure, thromboembolic diseases, multiorgan failure) and mortality. To date, no pharmacologic treatment has been shown to effectively improve clinical outcomes in patients with COVID-19. Multiple ongoing clinical trials are being conducted globally to determine potential therapeutic treatments for severe COVID-19. The first clinical trials of hydroxychloroquine and lopinavir-ritonavir, agents traditionally used for other indications, such as malaria and HIV, did not show a clear benefit in COVID-19.^1,2 Remdesivir, a nucleoside analogue prodrug, is a broad-spectrum antiviral agent that was previously used for treatment of Ebola and has been shown to have inhibitory effects on pathogenic coronaviruses. The study reported by Wang and colleagues was the first randomized controlled trial (RCT) aimed at evaluating whether remdesivir improves outcomes in patients with severe COVID-19. Thus, the worsening COVID-19 pandemic, coupled with the absence of a curative treatment, underscore the urgency of this trial.

The study was grounded on observational data from several recent case reports and case series centering on the potential efficacy of remdesivir in treating COVID-19.³ The study itself was designed well (ie, randomized, placebo-controlled, double-blind, multicenter) and carefully implemented (ie, high protocol adherence to treatments, no loss to follow-up). The principal limitation of this study was its inability to reach the estimated statistical power of study. Due to successful epidemic control in Wuhan, which led to marked reductions in hospital admission of patients with COVID-19, and implementation of stringent termination criteria per the study protocol, only 237 participants were enrolled, instead of the 453, as specified by the sample estimate. This corresponded to a reduction of statistical power from 80% to 58%. Due to this limitation, the study was underpowered, rendering its findings inconclusive.

Despite this limitation, the study found that those treated with remdesivir within 10 days of symptom onset had a numerically faster time (although not statistically significant) to clinical improvement. This leads to an interesting question: whether remdesivir administration early in COVID-19 course could improve clinical outcomes, a question that warrants further investigation by an adequately powered trial. Also, data from this study provided evidence that intravenous remdesivir administration is likely safe in adults during the treatment period, although the long-term drug effects, as well as the safety profile in pediatric patients, remain unknown at this time.

While the study reported by Wang and colleagues was underpowered and is thus inconclusive, several other ongoing RCTs are evaluating the potential clinical benefit of remdesivir treatment in patients hospitalized with COVID-19. On the date of online publication of this report in The Lancet, the National Institutes of Health (NIH) published a news release summarizing preliminary findings from the Adaptive COVID-19 Treatment Trial (ACTT), which showed positive effects of remdesivir on clinical recovery from advanced COVID-19.⁴ The ACTT, the first RCT launched in the United States to evaluate experimental treatment for COVID-19, included 1063 hospitalized participants with advanced COVID-19 and lung involvement. Participants who were administered remdesivir had a 31% faster time to recovery compared to those in the placebo group (median time to recovery, 11 days vs 15 days, respectively; P < 0.001), and had near statistically significant improved survival (mortality rate, 8.0% vs 11.6%, respectively; P = 0.059). In response to these findings, the US Food and Drug Administration (FDA) issued an emergency use authorization for remdesivir on May 1, 2020, for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.⁵ While the findings noted from the NIH news release are very encouraging and provide the first evidence of a potentially beneficial antiviral treatment for severe COVID-19 in humans, the scientific community awaits the peer-reviewed publication of the ACTT to better assess the safety and effectiveness of remdesivir therapy and determine the trial’s implications in the management of COVID-19.

 

 

Applications for Clinical Practice

The discovery of an effective pharmacologic intervention for COVID-19 is of utmost urgency. While the present study was unable to answer the question of whether remdesivir is effective in improving clinical outcomes in patients with severe COVID-19, other ongoing or completed (ie, ACTT) studies will likely address this knowledge gap in the coming months. The FDA’s emergency use authorization for remdesivir provides a glimpse into this possibility.

–Katerina Oikonomou, MD, Brookdale Department of Geriatrics & Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY

–Fred Ko, MD

Children with neurologic impairment (NI; eg, hypoxic-­ischemic encephalopathy, muscular dystrophy) are characterized by functional and/or intellectual impairments resulting from a variety of neurologic diseases.¹ These children commonly have respiratory comorbidities, including central hypoventilation, impaired cough, and oromotor dysfunction, that may lead to chronic respiratory insufficiency and a need for chronic respiratory support at baseline.^2,3 Baseline respiratory support modalities can include supplemental oxygen, noninvasive positive pressure ventilation, or invasive mechanical ventilation.

Acute respiratory infections (ARI; eg, pneumonia, bronchiolitis) are the most common cause of hospitalization, intensive care unit (ICU) admission, and death for children with NI.^1,3 Discharge criteria for otherwise healthy children admitted to the hospital with ARI often include return to respiratory baseline.⁴ Children with complex chronic conditions have longer hospitalizations when hospitalized with respiratory infections,^5-7 because, in part, comorbidities and complications prolong the time to return to baseline. This prolonged return to respiratory baseline in combination with family knowledge, comfort, and skill in managing respiratory support and other complexities at home may alter discharge practices in the population of children with NI. In our clinical experience, discharge before return to baseline respiratory support occurs more frequently in children with NI than in otherwise healthy children when hospitalized with ARI. However, the consequences of discharging children with NI prior to return to respiratory baseline are unknown.

In this study, we sought to determine if discharge prior to return to baseline respiratory support is associated with reutilization among children with NI hospitalized with ARI. We hypothesized that patients discharged prior to return to respiratory baseline would have higher rates of 30-day hospital reutilization.

Study Design and Data Source

This single-center, retrospective cohort study of children hospitalized at Cincinnati Children’s Hospital Medical Center (CCHMC) used data from the Pediatric Health Information System (PHIS) and the electronic medical record (EMR). PHIS, an administrative database of 45 not-for-profit, tertiary care, US pediatric hospitals managed by Children’s Hospital Association (Lenexa, Kansas), was used to identify eligible children, examine demographic and clinical variables, and define outcomes. PHIS contains data regarding patient demographics, inpatient resource utilization, and diagnoses. Encrypted medical record numbers in PHIS allowed for local identification of patients’ medical records to complete EMR review to confirm eligibility and obtain detailed patient-level clinical information (eg, respiratory support needs) not available in PHIS.

Pilot medical record reviews allowed for standardized study definitions and procedures. All study staff underwent training with the primary investigator, including detailed review of 10 initial abstractions. Two investigators (K.M. and S.C.) performed repeat abstractions from 40 randomly selected records to enable assessment of interrater reliability. Average reliability, indicated by the κ statistic, indicated substantial to near-perfect reliability⁸ (κ = 0.97, 95% CI 0.90-1.00) for the primary exposure. EMR data were managed using Research Electronic Data Capture (REDCap, Nashville, Tennessee)⁹ and subsequently merged with PHIS data.

Study Population

Hospitalizations of children with NI aged 1 to 18 years at CCHMC between January 2010 and September 2015 were eligible for inclusion if they had a principal discharge diagnosis indicative of ARI and required increased respiratory support from baseline during hospitalization. NI was defined as a high-intensity, chronic neurological diagnosis with substantial functional impairments according to previously defined diagnosis codes.^1,10 ARI was identified using codes in the Clinical Classification Software (Agency for Healthcare Research and Quality, Rockville, MD) respiratory group indicative of ARI (eg, pneumonia, bronchiolitis, influenza; Appendix Table).

Children transferred to CCHMC were excluded because records from their initial illness presentation and management were not available. Because of expected differences in management and outcomes, children with a known diagnosis of tuberculosis or human immunodeficiency virus were excluded. Because exposure criteria were dependent on hospital discharge status, hospitalizations for children who died during admission (4 of 632 hospitalizations, 0.63%) were excluded from the final cohort (Appendix Figure).

Study Definitions

Baseline respiratory support (ie, “respiratory baseline”) was defined as the child’s highest level of respiratory support needed prior to admission when well (ie, no support, supplemental oxygen, continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP], or ventilator support), and further characterized by night or day/night requirement. Respiratory baseline was identified using EMR documentation of home respiratory support use at the time of index admission. Return to respiratory baseline was defined as the date on which the child achieved documented home respiratory support settings, regardless of clinical symptoms.

Children may have required increased respiratory support from baseline at any time during hospitalization. Maximum respiratory support required was categorized as one of the following: (1) initiation of supplemental oxygen or increase in oxygen flow or duration; (2) initiation of CPAP or BiPAP; (3) increase in pressure settings or duration of pressure support for those with baseline CPAP, BiPAP, or ventilator use; and (4) initiation of full mechanical ventilation. Respiratory support categories were mutually exclusive: children requiring multiple types of increased respiratory support were classified for analysis by the most invasive form of respiratory support used (eg, a child requiring increase in both oxygen flow and pressure settings was categorized as an increase in pressure settings). Children who received heated high-flow nasal cannula therapy as maximum support were categorized as initiation or increase in oxygen support.

Time to return to respiratory baseline was defined as the difference in days between date of return to respiratory baseline and date of admission. Time to return to respiratory baseline was determined only for children who were discharged at respiratory baseline.

Primary Exposure and Outcome Measures

The primary exposure was hospital discharge before return to respiratory baseline (ie, discharge on higher respiratory support than at baseline settings). At our institution, standardized discharge criteria for children with NI do not exist. The primary outcome was all-cause, 30-day hospital reutilization, including hospital readmissions and emergency department (ED) revisits. Secondary outcomes included 30-day reutilization for ARI and hospital length of stay (LOS) in days.

Patient Demographics and Clinical Characteristics

Demographic and patient characteristics that might influence hospital discharge before return to respiratory baseline or readmission were obtained from PHIS (eg, demographic information, age, insurance type, measures of clinical complexity, illness severity) and by EMR review (eg, baseline respiratory support needs, maximum respiratory support during hospitalization). Measures of clinical complexity included comorbid complex chronic conditions (CCCs)^11-14 and technology dependence^14-16 using previously defined diagnostic codes. Measures of illness severity included sepsis¹⁷ and ICU-level care. At our institution, children with baseline ventilator use do not require admission to the ICU unless they are clinically unstable.

Statistical Analysis

Continuous variables were described using medians and interquartile ranges (IQR). Categorical variables were described using counts and percentages. Patient characteristics and outcomes were stratified by primary exposure and compared using chi-square test or Fisher exact test for categorical variables and Wilcoxon rank sum test for continuous variables.

To examine the independent association between discharge before return to respiratory baseline and hospital reutilization, a generalized estimating equation was used that included potential confounders while accounting for within-patient clustering. Patient demographics included age, race, ethnicity, and insurance type; measures of clinical complexity included number of CCCs, technology dependence, and baseline respiratory support; and measures of acute illness severity included ARI diagnosis, degree of increase in respiratory support during hospitalization, and ICU-level care. LOS was also included in the model as a covariate because of its expected association with both exposure and outcome.

Secondary analyses were conducted using the outcome of 30-day reutilization for ARI. Subgroup analysis excluding hospitalizations of children lost to follow-up (ie, no encounters in the 6 months after hospital discharge) was also conducted. All analyses were performed with SAS v9.3 (SAS Institute, Cary, North Carolina). P values < .05 were considered statistically significant. This study was approved by the Institutional Review Board.

Study Cohort

A total of 632 hospitalizations experienced by 366 children with NI who were admitted with ARI were included (Appendix Figure). Most children (66.4%) in the cohort experienced only one hospitalization, 17.5% had two hospitalizations, 7.9% had three hospitalizations, and 8.2% had four or more hospitalizations. The median age at hospitalization was 5.0 years (IQR 2.8-10.5) and most hospitalizations were for children who were male (56.6%), white (78.3%), non-Hispanic (96.0%), and publicly insured (51.7%; Table 1). More than one-quarter (28.6%) of hospitalizations were for children with four or more CCCs, and in 73.4% of hospitalizations, children were technology dependent (Table 1). Baseline respiratory support was common (46.8%), including home mechanical ventilation in 11.1% of hospitalizations (Table 1). Bacterial pneumonia, including aspiration pneumonia, was the most common discharge diagnosis (50.5%, Table 1).

Demographic and Clinical Characteristics

Children were discharged before return to respiratory baseline in 30.4% of hospitalizations (Appendix Figure). Children discharged before return to respiratory baseline were older (median age 5.7 years, IQR 3.1-11.0, vs 4.9 years, IQR 2.6-9.7; P = .04) and more likely to be privately insured (54.2% vs 43.4%; P = .04), compared with children discharged at respiratory baseline (Table 1). Children discharged before return to respiratory baseline were also more likely to have a respiratory CCC (59.9% vs 30.9%; P < .001), have a respiratory technology dependence diagnosis code (44.8% vs 24.1%; P < .001), and have baseline respiratory support needs on EMR review (67.7% vs 37.7%; P < .001), compared with children discharged at baseline (Table 1).

Children discharged before return to respiratory baseline required significantly greater escalation in respiratory support during hospitalization, compared with children discharged at respiratory baseline, including higher rates of initiation of CPAP or BiPAP, increased pressure settings from baseline (for home CPAP, BiPAP, or ventilator users), and initiation of full mechanical ventilation (Table 1). Hospitalizations in which children were discharged before return to respiratory baseline were also more likely to include ICU care than were those for children discharged at baseline (52.1% vs 35.2%; P < .001; Table 1).

Clinical Outcomes and Utilization

Reutilization within 30 days occurred after 32.1% of hospitalizations, with 26.1% requiring hospital readmission and 6.0% requiring ED revisit (Table 2). There was no statistical association in either unadjusted (Table 2) or adjusted (Table 3) analysis between children discharged before return to respiratory baseline and 30-day all-cause hospital reutilizations, hospital readmissions, or ED revisits.

In analysis of secondary outcomes, 30-day reutilization because of ARI occurred after 21.5% of hospitalizations, with 19.0% requiring hospital readmission and 2.5% requiring ED revisit. Median hospital LOS for the cohort was 4 days (IQR 2-8; Table 2). Hospitalizations in which children were discharged before return to respiratory baseline were longer than in those discharged at baseline (median 6 days, IQR 3-11, vs 4 days, IQR 2-7; P < .001; Table 2).

For hospitalizations of children discharged at respiratory baseline, the median time to return to respiratory baseline was 3 days (IQR 1-5, complete range 0-80). In these encounters, discharge occurred soon after return to respiratory baseline (median 1 day, IQR 0-1.5, complete range 0-54).

In subgroup analysis excluding the 18 hospitalizations in which children were lost to follow-up (2.8% of the total cohort), discharge before return to respiratory baseline was not associated with 30-day all-cause hospital reutilization (Table 4).

In this retrospective cohort study, children with NI hospitalized with ARI were frequently discharged using increased respiratory support from baseline. However, those discharged before return to respiratory baseline, despite their greater clinical complexity and acute illness severity, did not have increased hospital reutilization, compared with children discharged at respiratory baseline. Our findings suggest that discharge before return to baseline respiratory support after ARI may be clinically appropriate in some children with NI.

With the growing emphasis on decreasing hospital costs, concern exists that patients are being discharged from hospitals “quicker and sicker,”^18,19 with shortening lengths of stay and higher patient instability at discharge. Clinical instability at discharge has been associated with adverse postdischarge outcomes in adults with pneumonia^20-23; however, studies evaluating discharge readiness have not examined the population of children with NI. Our findings of no difference in reutilization for children with NI discharged before return to respiratory baseline, which would be expected to approximate one or more clinical instabilities, contrast these concerns.

Clinicians caring for children with NI hospitalized with ARI may find it difficult to determine a child’s discharge readiness, in part because many children with NI have longer times to return to respiratory baseline and some never return to their pre-­illness baseline.²⁴ In otherwise healthy children hospitalized with respiratory infections such as pneumonia, discharge criteria typically include complete wean from respiratory support prior to discharge.^4,25 In our study’s more complex children, whose parents already manage respiratory support at home, we hypothesize that discharging providers may be comfortable with discharge when the child has certain types of increased respiratory support compatible with home equipment, a parent skilled with monitoring the child’s respiratory status, and the support of an experienced outpatient provider and home nursing providers. At our institution, outpatient respiratory support weans are primarily performed by pediatric pulmonologists and, for isolated weaning of supplemental oxygen or time using support, by parents and outpatient pediatricians.

Another important factor in determining a child’s discharge readiness is the perspective of the child’s parent. Berry et al found that children whose parents believe they are not healthy enough for discharge are more likely to experience unplanned hospital readmissions,²⁴ signaling the role of child- and family-­specific factors in safe discharge decisions. Therefore, parents of children with NI should be proactively involved throughout the multidisciplinary discharge process,^26,27 including the decision to discharge before return to respiratory baseline. Parents have identified ongoing provider support, opportunities to practice home care skills, and written instructions with contingency plans as important components of discharge readiness.²⁸ Further work to create partnerships with these highly skilled caregivers in discharge decision making and transition planning are needed to promote safe discharge practices in this complex population.

In our study, children discharged before return to respiratory baseline were more likely to be older and privately insured compared with children discharged at respiratory baseline. Prior studies have found that social factors including low socioeconomic status influence ED provider admissions decisions for children with pneumonia.^29,30 However, the role of socioeconomic factors in provider discharge decisions for children with NI has not been assessed. These traits may also be proxy markers of other sociodemographic factors, such as parent education level, financial hardship influencing ability to participate in a child’s care at the bedside, access to comprehensive outpatient primary care, and availability of private home nursing. We hypothesize that these related characteristics directly and indirectly influence provider discharge decisions.

Discharging providers are likely more comfortable with discharge prior to return to respiratory baseline when the family has private duty nursing in the home. Home nurses can assist families in providing increased respiratory support and recognizing respiratory problems that may arise following discharge. However, home nursing shortages are common nationwide.^31,32 Low-income children, children with respiratory technology use, and children without Medicaid have been found to have larger gaps in home nursing availability.^31,32 Further studies are needed to understand the role of home nursing availability in provider discharge decisions in this population.

This study has several limitations. The retrospective design of this study creates the potential for residual confounding; there may be other clinical or demographic factors influencing hospital discharge decisions that we are unable to capture using EMR review, including parental knowledge and comfort managing illness, quality of discharge instructions, frequency of follow-up visits, and presence of skilled home nursing services. Categorization of children based on respiratory support status at discharge lends potential for misclassification of exposure; however, our substantial interrater reliability suggests that misclassification bias is small. This study’s primary finding indicated no difference between exposure groups; although we may be unable to detect small differences, we had sufficient power with our sample size to detect meaningful differences in reutilization outcomes.

This study was not designed to capture outpatient time to return to respiratory baseline; prospective studies are needed to identify rates of return to respiratory baseline following ARI in children with NI. We did not measure the level of respiratory support used by children at the time of discharge and, therefore, are unable to estimate the amount of respiratory support weaning needed following discharge or the compatibility of support with home equipment using our data. In addition, this study focused on respiratory support modalities and, thus, did not measure inpatient utilization of mucociliary clearance technologies that might be hypothesized to decrease the time to return to baseline respiratory support. Next steps in evaluating treatment of ARI include investigating the effect of mucociliary clearance on both exposure and outcome in this population.

There may be other clinically meaningful outcomes for this population apart from reutilization that we have not assessed in this study, including increased respiratory support required following discharge, primary care reutilization, healthcare costs, or parent satisfaction with timing of and outcomes after discharge. Finally, although our hospital has reutilization rates for children with NI that are similar to other institutions in the United States,³³ our results may not be generalizable to children with NI hospitalized at other institutions because local discharge processes and systems of care may be different. Prospective, multicenter investigation is needed to evaluate the clinical consequences of discharge before return to respiratory baseline more broadly.

At our institution, approximately one-quarter of children with NI hospitalized with ARI were discharged before return to respiratory baseline, but these children were not at increased risk of reutilization, compared with children discharged at respiratory baseline. Our findings suggest that return to baseline respiratory support might not be a necessary component of hospital discharge criteria. In otherwise clinically stable children with NI, discharge before return to respiratory baseline may be reasonable if their parents are comfortable managing respiratory support at home.

The authors thank Jonathan Rodean of the Children’s Hospital Association for his assistance with abstraction of PHIS data.

Children with neurologic impairment (NI; eg, hypoxic-­ischemic encephalopathy, muscular dystrophy) are characterized by functional and/or intellectual impairments resulting from a variety of neurologic diseases.¹ These children commonly have respiratory comorbidities, including central hypoventilation, impaired cough, and oromotor dysfunction, that may lead to chronic respiratory insufficiency and a need for chronic respiratory support at baseline.^2,3 Baseline respiratory support modalities can include supplemental oxygen, noninvasive positive pressure ventilation, or invasive mechanical ventilation.

Acute respiratory infections (ARI; eg, pneumonia, bronchiolitis) are the most common cause of hospitalization, intensive care unit (ICU) admission, and death for children with NI.^1,3 Discharge criteria for otherwise healthy children admitted to the hospital with ARI often include return to respiratory baseline.⁴ Children with complex chronic conditions have longer hospitalizations when hospitalized with respiratory infections,^5-7 because, in part, comorbidities and complications prolong the time to return to baseline. This prolonged return to respiratory baseline in combination with family knowledge, comfort, and skill in managing respiratory support and other complexities at home may alter discharge practices in the population of children with NI. In our clinical experience, discharge before return to baseline respiratory support occurs more frequently in children with NI than in otherwise healthy children when hospitalized with ARI. However, the consequences of discharging children with NI prior to return to respiratory baseline are unknown.

In this study, we sought to determine if discharge prior to return to baseline respiratory support is associated with reutilization among children with NI hospitalized with ARI. We hypothesized that patients discharged prior to return to respiratory baseline would have higher rates of 30-day hospital reutilization.

Study Design and Data Source

This single-center, retrospective cohort study of children hospitalized at Cincinnati Children’s Hospital Medical Center (CCHMC) used data from the Pediatric Health Information System (PHIS) and the electronic medical record (EMR). PHIS, an administrative database of 45 not-for-profit, tertiary care, US pediatric hospitals managed by Children’s Hospital Association (Lenexa, Kansas), was used to identify eligible children, examine demographic and clinical variables, and define outcomes. PHIS contains data regarding patient demographics, inpatient resource utilization, and diagnoses. Encrypted medical record numbers in PHIS allowed for local identification of patients’ medical records to complete EMR review to confirm eligibility and obtain detailed patient-level clinical information (eg, respiratory support needs) not available in PHIS.

Pilot medical record reviews allowed for standardized study definitions and procedures. All study staff underwent training with the primary investigator, including detailed review of 10 initial abstractions. Two investigators (K.M. and S.C.) performed repeat abstractions from 40 randomly selected records to enable assessment of interrater reliability. Average reliability, indicated by the κ statistic, indicated substantial to near-perfect reliability⁸ (κ = 0.97, 95% CI 0.90-1.00) for the primary exposure. EMR data were managed using Research Electronic Data Capture (REDCap, Nashville, Tennessee)⁹ and subsequently merged with PHIS data.

Study Population

Hospitalizations of children with NI aged 1 to 18 years at CCHMC between January 2010 and September 2015 were eligible for inclusion if they had a principal discharge diagnosis indicative of ARI and required increased respiratory support from baseline during hospitalization. NI was defined as a high-intensity, chronic neurological diagnosis with substantial functional impairments according to previously defined diagnosis codes.^1,10 ARI was identified using codes in the Clinical Classification Software (Agency for Healthcare Research and Quality, Rockville, MD) respiratory group indicative of ARI (eg, pneumonia, bronchiolitis, influenza; Appendix Table).

Children transferred to CCHMC were excluded because records from their initial illness presentation and management were not available. Because of expected differences in management and outcomes, children with a known diagnosis of tuberculosis or human immunodeficiency virus were excluded. Because exposure criteria were dependent on hospital discharge status, hospitalizations for children who died during admission (4 of 632 hospitalizations, 0.63%) were excluded from the final cohort (Appendix Figure).

Study Definitions

Baseline respiratory support (ie, “respiratory baseline”) was defined as the child’s highest level of respiratory support needed prior to admission when well (ie, no support, supplemental oxygen, continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP], or ventilator support), and further characterized by night or day/night requirement. Respiratory baseline was identified using EMR documentation of home respiratory support use at the time of index admission. Return to respiratory baseline was defined as the date on which the child achieved documented home respiratory support settings, regardless of clinical symptoms.

Children may have required increased respiratory support from baseline at any time during hospitalization. Maximum respiratory support required was categorized as one of the following: (1) initiation of supplemental oxygen or increase in oxygen flow or duration; (2) initiation of CPAP or BiPAP; (3) increase in pressure settings or duration of pressure support for those with baseline CPAP, BiPAP, or ventilator use; and (4) initiation of full mechanical ventilation. Respiratory support categories were mutually exclusive: children requiring multiple types of increased respiratory support were classified for analysis by the most invasive form of respiratory support used (eg, a child requiring increase in both oxygen flow and pressure settings was categorized as an increase in pressure settings). Children who received heated high-flow nasal cannula therapy as maximum support were categorized as initiation or increase in oxygen support.

Time to return to respiratory baseline was defined as the difference in days between date of return to respiratory baseline and date of admission. Time to return to respiratory baseline was determined only for children who were discharged at respiratory baseline.

Primary Exposure and Outcome Measures

The primary exposure was hospital discharge before return to respiratory baseline (ie, discharge on higher respiratory support than at baseline settings). At our institution, standardized discharge criteria for children with NI do not exist. The primary outcome was all-cause, 30-day hospital reutilization, including hospital readmissions and emergency department (ED) revisits. Secondary outcomes included 30-day reutilization for ARI and hospital length of stay (LOS) in days.

Patient Demographics and Clinical Characteristics

Demographic and patient characteristics that might influence hospital discharge before return to respiratory baseline or readmission were obtained from PHIS (eg, demographic information, age, insurance type, measures of clinical complexity, illness severity) and by EMR review (eg, baseline respiratory support needs, maximum respiratory support during hospitalization). Measures of clinical complexity included comorbid complex chronic conditions (CCCs)^11-14 and technology dependence^14-16 using previously defined diagnostic codes. Measures of illness severity included sepsis¹⁷ and ICU-level care. At our institution, children with baseline ventilator use do not require admission to the ICU unless they are clinically unstable.

Statistical Analysis

Continuous variables were described using medians and interquartile ranges (IQR). Categorical variables were described using counts and percentages. Patient characteristics and outcomes were stratified by primary exposure and compared using chi-square test or Fisher exact test for categorical variables and Wilcoxon rank sum test for continuous variables.

To examine the independent association between discharge before return to respiratory baseline and hospital reutilization, a generalized estimating equation was used that included potential confounders while accounting for within-patient clustering. Patient demographics included age, race, ethnicity, and insurance type; measures of clinical complexity included number of CCCs, technology dependence, and baseline respiratory support; and measures of acute illness severity included ARI diagnosis, degree of increase in respiratory support during hospitalization, and ICU-level care. LOS was also included in the model as a covariate because of its expected association with both exposure and outcome.

Secondary analyses were conducted using the outcome of 30-day reutilization for ARI. Subgroup analysis excluding hospitalizations of children lost to follow-up (ie, no encounters in the 6 months after hospital discharge) was also conducted. All analyses were performed with SAS v9.3 (SAS Institute, Cary, North Carolina). P values < .05 were considered statistically significant. This study was approved by the Institutional Review Board.

Study Cohort

A total of 632 hospitalizations experienced by 366 children with NI who were admitted with ARI were included (Appendix Figure). Most children (66.4%) in the cohort experienced only one hospitalization, 17.5% had two hospitalizations, 7.9% had three hospitalizations, and 8.2% had four or more hospitalizations. The median age at hospitalization was 5.0 years (IQR 2.8-10.5) and most hospitalizations were for children who were male (56.6%), white (78.3%), non-Hispanic (96.0%), and publicly insured (51.7%; Table 1). More than one-quarter (28.6%) of hospitalizations were for children with four or more CCCs, and in 73.4% of hospitalizations, children were technology dependent (Table 1). Baseline respiratory support was common (46.8%), including home mechanical ventilation in 11.1% of hospitalizations (Table 1). Bacterial pneumonia, including aspiration pneumonia, was the most common discharge diagnosis (50.5%, Table 1).

Demographic and Clinical Characteristics

Children were discharged before return to respiratory baseline in 30.4% of hospitalizations (Appendix Figure). Children discharged before return to respiratory baseline were older (median age 5.7 years, IQR 3.1-11.0, vs 4.9 years, IQR 2.6-9.7; P = .04) and more likely to be privately insured (54.2% vs 43.4%; P = .04), compared with children discharged at respiratory baseline (Table 1). Children discharged before return to respiratory baseline were also more likely to have a respiratory CCC (59.9% vs 30.9%; P < .001), have a respiratory technology dependence diagnosis code (44.8% vs 24.1%; P < .001), and have baseline respiratory support needs on EMR review (67.7% vs 37.7%; P < .001), compared with children discharged at baseline (Table 1).

Children discharged before return to respiratory baseline required significantly greater escalation in respiratory support during hospitalization, compared with children discharged at respiratory baseline, including higher rates of initiation of CPAP or BiPAP, increased pressure settings from baseline (for home CPAP, BiPAP, or ventilator users), and initiation of full mechanical ventilation (Table 1). Hospitalizations in which children were discharged before return to respiratory baseline were also more likely to include ICU care than were those for children discharged at baseline (52.1% vs 35.2%; P < .001; Table 1).

Clinical Outcomes and Utilization

Reutilization within 30 days occurred after 32.1% of hospitalizations, with 26.1% requiring hospital readmission and 6.0% requiring ED revisit (Table 2). There was no statistical association in either unadjusted (Table 2) or adjusted (Table 3) analysis between children discharged before return to respiratory baseline and 30-day all-cause hospital reutilizations, hospital readmissions, or ED revisits.

In analysis of secondary outcomes, 30-day reutilization because of ARI occurred after 21.5% of hospitalizations, with 19.0% requiring hospital readmission and 2.5% requiring ED revisit. Median hospital LOS for the cohort was 4 days (IQR 2-8; Table 2). Hospitalizations in which children were discharged before return to respiratory baseline were longer than in those discharged at baseline (median 6 days, IQR 3-11, vs 4 days, IQR 2-7; P < .001; Table 2).

For hospitalizations of children discharged at respiratory baseline, the median time to return to respiratory baseline was 3 days (IQR 1-5, complete range 0-80). In these encounters, discharge occurred soon after return to respiratory baseline (median 1 day, IQR 0-1.5, complete range 0-54).

In subgroup analysis excluding the 18 hospitalizations in which children were lost to follow-up (2.8% of the total cohort), discharge before return to respiratory baseline was not associated with 30-day all-cause hospital reutilization (Table 4).

In this retrospective cohort study, children with NI hospitalized with ARI were frequently discharged using increased respiratory support from baseline. However, those discharged before return to respiratory baseline, despite their greater clinical complexity and acute illness severity, did not have increased hospital reutilization, compared with children discharged at respiratory baseline. Our findings suggest that discharge before return to baseline respiratory support after ARI may be clinically appropriate in some children with NI.

With the growing emphasis on decreasing hospital costs, concern exists that patients are being discharged from hospitals “quicker and sicker,”^18,19 with shortening lengths of stay and higher patient instability at discharge. Clinical instability at discharge has been associated with adverse postdischarge outcomes in adults with pneumonia^20-23; however, studies evaluating discharge readiness have not examined the population of children with NI. Our findings of no difference in reutilization for children with NI discharged before return to respiratory baseline, which would be expected to approximate one or more clinical instabilities, contrast these concerns.

Clinicians caring for children with NI hospitalized with ARI may find it difficult to determine a child’s discharge readiness, in part because many children with NI have longer times to return to respiratory baseline and some never return to their pre-­illness baseline.²⁴ In otherwise healthy children hospitalized with respiratory infections such as pneumonia, discharge criteria typically include complete wean from respiratory support prior to discharge.^4,25 In our study’s more complex children, whose parents already manage respiratory support at home, we hypothesize that discharging providers may be comfortable with discharge when the child has certain types of increased respiratory support compatible with home equipment, a parent skilled with monitoring the child’s respiratory status, and the support of an experienced outpatient provider and home nursing providers. At our institution, outpatient respiratory support weans are primarily performed by pediatric pulmonologists and, for isolated weaning of supplemental oxygen or time using support, by parents and outpatient pediatricians.

Another important factor in determining a child’s discharge readiness is the perspective of the child’s parent. Berry et al found that children whose parents believe they are not healthy enough for discharge are more likely to experience unplanned hospital readmissions,²⁴ signaling the role of child- and family-­specific factors in safe discharge decisions. Therefore, parents of children with NI should be proactively involved throughout the multidisciplinary discharge process,^26,27 including the decision to discharge before return to respiratory baseline. Parents have identified ongoing provider support, opportunities to practice home care skills, and written instructions with contingency plans as important components of discharge readiness.²⁸ Further work to create partnerships with these highly skilled caregivers in discharge decision making and transition planning are needed to promote safe discharge practices in this complex population.

In our study, children discharged before return to respiratory baseline were more likely to be older and privately insured compared with children discharged at respiratory baseline. Prior studies have found that social factors including low socioeconomic status influence ED provider admissions decisions for children with pneumonia.^29,30 However, the role of socioeconomic factors in provider discharge decisions for children with NI has not been assessed. These traits may also be proxy markers of other sociodemographic factors, such as parent education level, financial hardship influencing ability to participate in a child’s care at the bedside, access to comprehensive outpatient primary care, and availability of private home nursing. We hypothesize that these related characteristics directly and indirectly influence provider discharge decisions.

Discharging providers are likely more comfortable with discharge prior to return to respiratory baseline when the family has private duty nursing in the home. Home nurses can assist families in providing increased respiratory support and recognizing respiratory problems that may arise following discharge. However, home nursing shortages are common nationwide.^31,32 Low-income children, children with respiratory technology use, and children without Medicaid have been found to have larger gaps in home nursing availability.^31,32 Further studies are needed to understand the role of home nursing availability in provider discharge decisions in this population.

This study has several limitations. The retrospective design of this study creates the potential for residual confounding; there may be other clinical or demographic factors influencing hospital discharge decisions that we are unable to capture using EMR review, including parental knowledge and comfort managing illness, quality of discharge instructions, frequency of follow-up visits, and presence of skilled home nursing services. Categorization of children based on respiratory support status at discharge lends potential for misclassification of exposure; however, our substantial interrater reliability suggests that misclassification bias is small. This study’s primary finding indicated no difference between exposure groups; although we may be unable to detect small differences, we had sufficient power with our sample size to detect meaningful differences in reutilization outcomes.

This study was not designed to capture outpatient time to return to respiratory baseline; prospective studies are needed to identify rates of return to respiratory baseline following ARI in children with NI. We did not measure the level of respiratory support used by children at the time of discharge and, therefore, are unable to estimate the amount of respiratory support weaning needed following discharge or the compatibility of support with home equipment using our data. In addition, this study focused on respiratory support modalities and, thus, did not measure inpatient utilization of mucociliary clearance technologies that might be hypothesized to decrease the time to return to baseline respiratory support. Next steps in evaluating treatment of ARI include investigating the effect of mucociliary clearance on both exposure and outcome in this population.

There may be other clinically meaningful outcomes for this population apart from reutilization that we have not assessed in this study, including increased respiratory support required following discharge, primary care reutilization, healthcare costs, or parent satisfaction with timing of and outcomes after discharge. Finally, although our hospital has reutilization rates for children with NI that are similar to other institutions in the United States,³³ our results may not be generalizable to children with NI hospitalized at other institutions because local discharge processes and systems of care may be different. Prospective, multicenter investigation is needed to evaluate the clinical consequences of discharge before return to respiratory baseline more broadly.

At our institution, approximately one-quarter of children with NI hospitalized with ARI were discharged before return to respiratory baseline, but these children were not at increased risk of reutilization, compared with children discharged at respiratory baseline. Our findings suggest that return to baseline respiratory support might not be a necessary component of hospital discharge criteria. In otherwise clinically stable children with NI, discharge before return to respiratory baseline may be reasonable if their parents are comfortable managing respiratory support at home.

The authors thank Jonathan Rodean of the Children’s Hospital Association for his assistance with abstraction of PHIS data.

Children with neurologic impairment (NI; eg, hypoxic-­ischemic encephalopathy, muscular dystrophy) are characterized by functional and/or intellectual impairments resulting from a variety of neurologic diseases.¹ These children commonly have respiratory comorbidities, including central hypoventilation, impaired cough, and oromotor dysfunction, that may lead to chronic respiratory insufficiency and a need for chronic respiratory support at baseline.^2,3 Baseline respiratory support modalities can include supplemental oxygen, noninvasive positive pressure ventilation, or invasive mechanical ventilation.

Acute respiratory infections (ARI; eg, pneumonia, bronchiolitis) are the most common cause of hospitalization, intensive care unit (ICU) admission, and death for children with NI.^1,3 Discharge criteria for otherwise healthy children admitted to the hospital with ARI often include return to respiratory baseline.⁴ Children with complex chronic conditions have longer hospitalizations when hospitalized with respiratory infections,^5-7 because, in part, comorbidities and complications prolong the time to return to baseline. This prolonged return to respiratory baseline in combination with family knowledge, comfort, and skill in managing respiratory support and other complexities at home may alter discharge practices in the population of children with NI. In our clinical experience, discharge before return to baseline respiratory support occurs more frequently in children with NI than in otherwise healthy children when hospitalized with ARI. However, the consequences of discharging children with NI prior to return to respiratory baseline are unknown.

In this study, we sought to determine if discharge prior to return to baseline respiratory support is associated with reutilization among children with NI hospitalized with ARI. We hypothesized that patients discharged prior to return to respiratory baseline would have higher rates of 30-day hospital reutilization.

Study Design and Data Source

This single-center, retrospective cohort study of children hospitalized at Cincinnati Children’s Hospital Medical Center (CCHMC) used data from the Pediatric Health Information System (PHIS) and the electronic medical record (EMR). PHIS, an administrative database of 45 not-for-profit, tertiary care, US pediatric hospitals managed by Children’s Hospital Association (Lenexa, Kansas), was used to identify eligible children, examine demographic and clinical variables, and define outcomes. PHIS contains data regarding patient demographics, inpatient resource utilization, and diagnoses. Encrypted medical record numbers in PHIS allowed for local identification of patients’ medical records to complete EMR review to confirm eligibility and obtain detailed patient-level clinical information (eg, respiratory support needs) not available in PHIS.

Pilot medical record reviews allowed for standardized study definitions and procedures. All study staff underwent training with the primary investigator, including detailed review of 10 initial abstractions. Two investigators (K.M. and S.C.) performed repeat abstractions from 40 randomly selected records to enable assessment of interrater reliability. Average reliability, indicated by the κ statistic, indicated substantial to near-perfect reliability⁸ (κ = 0.97, 95% CI 0.90-1.00) for the primary exposure. EMR data were managed using Research Electronic Data Capture (REDCap, Nashville, Tennessee)⁹ and subsequently merged with PHIS data.

Study Population

Hospitalizations of children with NI aged 1 to 18 years at CCHMC between January 2010 and September 2015 were eligible for inclusion if they had a principal discharge diagnosis indicative of ARI and required increased respiratory support from baseline during hospitalization. NI was defined as a high-intensity, chronic neurological diagnosis with substantial functional impairments according to previously defined diagnosis codes.^1,10 ARI was identified using codes in the Clinical Classification Software (Agency for Healthcare Research and Quality, Rockville, MD) respiratory group indicative of ARI (eg, pneumonia, bronchiolitis, influenza; Appendix Table).

Children transferred to CCHMC were excluded because records from their initial illness presentation and management were not available. Because of expected differences in management and outcomes, children with a known diagnosis of tuberculosis or human immunodeficiency virus were excluded. Because exposure criteria were dependent on hospital discharge status, hospitalizations for children who died during admission (4 of 632 hospitalizations, 0.63%) were excluded from the final cohort (Appendix Figure).

Study Definitions

Baseline respiratory support (ie, “respiratory baseline”) was defined as the child’s highest level of respiratory support needed prior to admission when well (ie, no support, supplemental oxygen, continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP], or ventilator support), and further characterized by night or day/night requirement. Respiratory baseline was identified using EMR documentation of home respiratory support use at the time of index admission. Return to respiratory baseline was defined as the date on which the child achieved documented home respiratory support settings, regardless of clinical symptoms.

Children may have required increased respiratory support from baseline at any time during hospitalization. Maximum respiratory support required was categorized as one of the following: (1) initiation of supplemental oxygen or increase in oxygen flow or duration; (2) initiation of CPAP or BiPAP; (3) increase in pressure settings or duration of pressure support for those with baseline CPAP, BiPAP, or ventilator use; and (4) initiation of full mechanical ventilation. Respiratory support categories were mutually exclusive: children requiring multiple types of increased respiratory support were classified for analysis by the most invasive form of respiratory support used (eg, a child requiring increase in both oxygen flow and pressure settings was categorized as an increase in pressure settings). Children who received heated high-flow nasal cannula therapy as maximum support were categorized as initiation or increase in oxygen support.

Time to return to respiratory baseline was defined as the difference in days between date of return to respiratory baseline and date of admission. Time to return to respiratory baseline was determined only for children who were discharged at respiratory baseline.

Primary Exposure and Outcome Measures

The primary exposure was hospital discharge before return to respiratory baseline (ie, discharge on higher respiratory support than at baseline settings). At our institution, standardized discharge criteria for children with NI do not exist. The primary outcome was all-cause, 30-day hospital reutilization, including hospital readmissions and emergency department (ED) revisits. Secondary outcomes included 30-day reutilization for ARI and hospital length of stay (LOS) in days.

Patient Demographics and Clinical Characteristics

Demographic and patient characteristics that might influence hospital discharge before return to respiratory baseline or readmission were obtained from PHIS (eg, demographic information, age, insurance type, measures of clinical complexity, illness severity) and by EMR review (eg, baseline respiratory support needs, maximum respiratory support during hospitalization). Measures of clinical complexity included comorbid complex chronic conditions (CCCs)^11-14 and technology dependence^14-16 using previously defined diagnostic codes. Measures of illness severity included sepsis¹⁷ and ICU-level care. At our institution, children with baseline ventilator use do not require admission to the ICU unless they are clinically unstable.

Statistical Analysis

Continuous variables were described using medians and interquartile ranges (IQR). Categorical variables were described using counts and percentages. Patient characteristics and outcomes were stratified by primary exposure and compared using chi-square test or Fisher exact test for categorical variables and Wilcoxon rank sum test for continuous variables.

To examine the independent association between discharge before return to respiratory baseline and hospital reutilization, a generalized estimating equation was used that included potential confounders while accounting for within-patient clustering. Patient demographics included age, race, ethnicity, and insurance type; measures of clinical complexity included number of CCCs, technology dependence, and baseline respiratory support; and measures of acute illness severity included ARI diagnosis, degree of increase in respiratory support during hospitalization, and ICU-level care. LOS was also included in the model as a covariate because of its expected association with both exposure and outcome.

Secondary analyses were conducted using the outcome of 30-day reutilization for ARI. Subgroup analysis excluding hospitalizations of children lost to follow-up (ie, no encounters in the 6 months after hospital discharge) was also conducted. All analyses were performed with SAS v9.3 (SAS Institute, Cary, North Carolina). P values < .05 were considered statistically significant. This study was approved by the Institutional Review Board.

Study Cohort

A total of 632 hospitalizations experienced by 366 children with NI who were admitted with ARI were included (Appendix Figure). Most children (66.4%) in the cohort experienced only one hospitalization, 17.5% had two hospitalizations, 7.9% had three hospitalizations, and 8.2% had four or more hospitalizations. The median age at hospitalization was 5.0 years (IQR 2.8-10.5) and most hospitalizations were for children who were male (56.6%), white (78.3%), non-Hispanic (96.0%), and publicly insured (51.7%; Table 1). More than one-quarter (28.6%) of hospitalizations were for children with four or more CCCs, and in 73.4% of hospitalizations, children were technology dependent (Table 1). Baseline respiratory support was common (46.8%), including home mechanical ventilation in 11.1% of hospitalizations (Table 1). Bacterial pneumonia, including aspiration pneumonia, was the most common discharge diagnosis (50.5%, Table 1).

Demographic and Clinical Characteristics

Children were discharged before return to respiratory baseline in 30.4% of hospitalizations (Appendix Figure). Children discharged before return to respiratory baseline were older (median age 5.7 years, IQR 3.1-11.0, vs 4.9 years, IQR 2.6-9.7; P = .04) and more likely to be privately insured (54.2% vs 43.4%; P = .04), compared with children discharged at respiratory baseline (Table 1). Children discharged before return to respiratory baseline were also more likely to have a respiratory CCC (59.9% vs 30.9%; P < .001), have a respiratory technology dependence diagnosis code (44.8% vs 24.1%; P < .001), and have baseline respiratory support needs on EMR review (67.7% vs 37.7%; P < .001), compared with children discharged at baseline (Table 1).

Children discharged before return to respiratory baseline required significantly greater escalation in respiratory support during hospitalization, compared with children discharged at respiratory baseline, including higher rates of initiation of CPAP or BiPAP, increased pressure settings from baseline (for home CPAP, BiPAP, or ventilator users), and initiation of full mechanical ventilation (Table 1). Hospitalizations in which children were discharged before return to respiratory baseline were also more likely to include ICU care than were those for children discharged at baseline (52.1% vs 35.2%; P < .001; Table 1).

Clinical Outcomes and Utilization

Reutilization within 30 days occurred after 32.1% of hospitalizations, with 26.1% requiring hospital readmission and 6.0% requiring ED revisit (Table 2). There was no statistical association in either unadjusted (Table 2) or adjusted (Table 3) analysis between children discharged before return to respiratory baseline and 30-day all-cause hospital reutilizations, hospital readmissions, or ED revisits.

In analysis of secondary outcomes, 30-day reutilization because of ARI occurred after 21.5% of hospitalizations, with 19.0% requiring hospital readmission and 2.5% requiring ED revisit. Median hospital LOS for the cohort was 4 days (IQR 2-8; Table 2). Hospitalizations in which children were discharged before return to respiratory baseline were longer than in those discharged at baseline (median 6 days, IQR 3-11, vs 4 days, IQR 2-7; P < .001; Table 2).

For hospitalizations of children discharged at respiratory baseline, the median time to return to respiratory baseline was 3 days (IQR 1-5, complete range 0-80). In these encounters, discharge occurred soon after return to respiratory baseline (median 1 day, IQR 0-1.5, complete range 0-54).

In subgroup analysis excluding the 18 hospitalizations in which children were lost to follow-up (2.8% of the total cohort), discharge before return to respiratory baseline was not associated with 30-day all-cause hospital reutilization (Table 4).

In this retrospective cohort study, children with NI hospitalized with ARI were frequently discharged using increased respiratory support from baseline. However, those discharged before return to respiratory baseline, despite their greater clinical complexity and acute illness severity, did not have increased hospital reutilization, compared with children discharged at respiratory baseline. Our findings suggest that discharge before return to baseline respiratory support after ARI may be clinically appropriate in some children with NI.

With the growing emphasis on decreasing hospital costs, concern exists that patients are being discharged from hospitals “quicker and sicker,”^18,19 with shortening lengths of stay and higher patient instability at discharge. Clinical instability at discharge has been associated with adverse postdischarge outcomes in adults with pneumonia^20-23; however, studies evaluating discharge readiness have not examined the population of children with NI. Our findings of no difference in reutilization for children with NI discharged before return to respiratory baseline, which would be expected to approximate one or more clinical instabilities, contrast these concerns.

Clinicians caring for children with NI hospitalized with ARI may find it difficult to determine a child’s discharge readiness, in part because many children with NI have longer times to return to respiratory baseline and some never return to their pre-­illness baseline.²⁴ In otherwise healthy children hospitalized with respiratory infections such as pneumonia, discharge criteria typically include complete wean from respiratory support prior to discharge.^4,25 In our study’s more complex children, whose parents already manage respiratory support at home, we hypothesize that discharging providers may be comfortable with discharge when the child has certain types of increased respiratory support compatible with home equipment, a parent skilled with monitoring the child’s respiratory status, and the support of an experienced outpatient provider and home nursing providers. At our institution, outpatient respiratory support weans are primarily performed by pediatric pulmonologists and, for isolated weaning of supplemental oxygen or time using support, by parents and outpatient pediatricians.

Another important factor in determining a child’s discharge readiness is the perspective of the child’s parent. Berry et al found that children whose parents believe they are not healthy enough for discharge are more likely to experience unplanned hospital readmissions,²⁴ signaling the role of child- and family-­specific factors in safe discharge decisions. Therefore, parents of children with NI should be proactively involved throughout the multidisciplinary discharge process,^26,27 including the decision to discharge before return to respiratory baseline. Parents have identified ongoing provider support, opportunities to practice home care skills, and written instructions with contingency plans as important components of discharge readiness.²⁸ Further work to create partnerships with these highly skilled caregivers in discharge decision making and transition planning are needed to promote safe discharge practices in this complex population.

In our study, children discharged before return to respiratory baseline were more likely to be older and privately insured compared with children discharged at respiratory baseline. Prior studies have found that social factors including low socioeconomic status influence ED provider admissions decisions for children with pneumonia.^29,30 However, the role of socioeconomic factors in provider discharge decisions for children with NI has not been assessed. These traits may also be proxy markers of other sociodemographic factors, such as parent education level, financial hardship influencing ability to participate in a child’s care at the bedside, access to comprehensive outpatient primary care, and availability of private home nursing. We hypothesize that these related characteristics directly and indirectly influence provider discharge decisions.

Discharging providers are likely more comfortable with discharge prior to return to respiratory baseline when the family has private duty nursing in the home. Home nurses can assist families in providing increased respiratory support and recognizing respiratory problems that may arise following discharge. However, home nursing shortages are common nationwide.^31,32 Low-income children, children with respiratory technology use, and children without Medicaid have been found to have larger gaps in home nursing availability.^31,32 Further studies are needed to understand the role of home nursing availability in provider discharge decisions in this population.

This study has several limitations. The retrospective design of this study creates the potential for residual confounding; there may be other clinical or demographic factors influencing hospital discharge decisions that we are unable to capture using EMR review, including parental knowledge and comfort managing illness, quality of discharge instructions, frequency of follow-up visits, and presence of skilled home nursing services. Categorization of children based on respiratory support status at discharge lends potential for misclassification of exposure; however, our substantial interrater reliability suggests that misclassification bias is small. This study’s primary finding indicated no difference between exposure groups; although we may be unable to detect small differences, we had sufficient power with our sample size to detect meaningful differences in reutilization outcomes.

This study was not designed to capture outpatient time to return to respiratory baseline; prospective studies are needed to identify rates of return to respiratory baseline following ARI in children with NI. We did not measure the level of respiratory support used by children at the time of discharge and, therefore, are unable to estimate the amount of respiratory support weaning needed following discharge or the compatibility of support with home equipment using our data. In addition, this study focused on respiratory support modalities and, thus, did not measure inpatient utilization of mucociliary clearance technologies that might be hypothesized to decrease the time to return to baseline respiratory support. Next steps in evaluating treatment of ARI include investigating the effect of mucociliary clearance on both exposure and outcome in this population.

There may be other clinically meaningful outcomes for this population apart from reutilization that we have not assessed in this study, including increased respiratory support required following discharge, primary care reutilization, healthcare costs, or parent satisfaction with timing of and outcomes after discharge. Finally, although our hospital has reutilization rates for children with NI that are similar to other institutions in the United States,³³ our results may not be generalizable to children with NI hospitalized at other institutions because local discharge processes and systems of care may be different. Prospective, multicenter investigation is needed to evaluate the clinical consequences of discharge before return to respiratory baseline more broadly.

At our institution, approximately one-quarter of children with NI hospitalized with ARI were discharged before return to respiratory baseline, but these children were not at increased risk of reutilization, compared with children discharged at respiratory baseline. Our findings suggest that return to baseline respiratory support might not be a necessary component of hospital discharge criteria. In otherwise clinically stable children with NI, discharge before return to respiratory baseline may be reasonable if their parents are comfortable managing respiratory support at home.

The authors thank Jonathan Rodean of the Children’s Hospital Association for his assistance with abstraction of PHIS data.

Increasing numbers of children and adolescents are presenting to children’s hospitals with acute mental health crises requiring emergent or inpatient treatment.^1-5 As a result, children’s hospitals are experiencing additional financial challenges because specialty mental health services are often reimbursed at lower rates than other medical services.^6-9 Poor reimbursement has also been cited as a deterrent to the provision of mental health specialty care, including emergency mental health crisis services.¹⁰ The cumulative financial impact of recent trends in the provision of mental health crisis services at children’s hospitals, however, is unknown. We conducted this study to assess children’s hospitals’ costs, reimbursement, and net profits or losses when delivering inpatient mental health care.

We conducted a retrospective cohort study of the Children’s Hospital Association’s Pediatric Health Information System (PHIS) and Revenue Management Program (RMP) databases. PHIS is an administrative and billing database that collects International Classification of Disease, 10th Revision (ICD-10) diagnoses, procedure codes, and hospital charges from encounters at 52 US children’s hospitals. Costs are estimated from charges using hospital-, year-, and department-specific cost-to-charge ratios. The RMP database is an add-on module to the PHIS database that captures reimbursement data submitted quarterly from 17 participating hospitals based on actual reimbursement amounts collected for each encounter.

Among the 17 participating hospitals, we included all medical (ie, not surgical or intensive care) encounters during calendar year 2017 for children older than 6 years. We stratified encounters into three diagnosis types: primary mental health diagnosis,⁵ suicide attempt,¹¹ or other medical hospitalizations. We separated suicide attempts since these encounters often require care for both mental health concerns and medical complications. Eating disorders were excluded because these programs at children’s hospitals primarily focus on medical complications, require complex multispecialty support, have significantly longer hospitalizations and made up a small volume of overall mental health hospitalizations.

We stratified all analyses by inpatient or observation encounter and determined the proportion of encounters and hospital days attributed to primary mental health, suicide attempt, and other medical conditions at each hospital. One of the 17 children’s hospitals does not use observation status billing, so the observation encounters dataset includes 16 hospitals.

We summarized patients’ demographic and clinical characteristics using frequencies and percentages, comparing across diagnosis groups using chi-square tests. We calculated mean cost per day as (total cost) ÷ (total length of stay [LOS]), reimbursement per day as (total reimbursement) ÷ (total LOS) for each hospital and patient group, and margin per day as (reimbursement per day) – (cost per day). We then determined the total margin difference of caring for mental health vs caring for other medical encounters as ([margin per day for mental health] – [margin per day other medical]) × (number of mental health days). Similarly, we calculated the total margin loss for suicide attempts vs other medical encounters. After calculating profits and losses at individual hospitals, we summed total annual profits and losses to calculate cumulative annual differences. We summarized these profits and losses across all hospitals with medians and interquartile ranges (IQR).

This study of deidentified administrative data was approved by the Internal Review Board at Vanderbilt University as non-human subjects research. All statistical analyses were performed using SAS v.9.4 (SAS Institute, Cary, North Carolina), and P values < .05 were considered statistically significant.

Study Population

Across the 17 included children’s hospitals, there were 8,521 (7.6%) mental health encounters, 3,247 (2.9%) suicide attempt encounters, and 99,937 (89.5%) other medical encounters. LOS was significantly longer for mental health hospitalizations than for suicide attempts and for other medical hospitalizations.

Hospital Characteristics

All 17 free-standing children’s hospitals in the study had an inpatient behavioral health/psychiatric consultation service, and 7 of the 17 had an inpatient behavioral health/psychiatric unit. The total number of discharges for mental health, suicide attempt, and other medical conditions per year varied (range, 2,868-13,214) across the hospitals.

Hospital Daily Profits and Losses for Mental Health, Suicide Attempt, and Other Medical Admissions

For inpatient status mental health hospitalizations, the median margin was $376/day (IQR, $23-$618). For inpatient status suicide attempt hospitalizations, the median margin was $685/day (IQR, $3-$1,117), and for other medical hospitalizations the median margin was $603/day (IQR, $240-$991). With regard to observation status admissions, mental health hospitalizations had a median margin of –$453/day (IQR, –$806 to $362), suicide attempts of –$103/day (IQR, –$639 to $264), and other medical conditions of $353/day (IQR, –$616 to $658; Figure).

Hospital Annual Profits and Losses for Mental Health and Suicide Attempt Admissions, Compared With Other Medical Admissions

The Table shows daily and annual profits and losses for inpatient and observation status. The total annual loss across all hospitals for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, including both inpatient and observation status, was –$26,658,255 when taking both profits and losses into account. For the seven hospitals with net profits for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, the median net profit for combined inpatient and observation status encounters was $119,361 (IQR, $82,818-$195,543), and the total net profit was $5,872,665. For the 10 hospitals with net losses for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, the median net loss for combined inpatient and observation status was –$2,169,357 (IQR, –$4,034,085 to –$511,755), and the total net loss was –$27,419,379.

Hospitalizations for mental health disorders and suicide attempts accounted for 10.5% of hospitalizations at 17 US children’s hospitals in 2017. Overall, mental health and suicide attempt hospitalizations had lower financial margins than did other medical hospitalizations, and they accounted for a total margin loss of more than $26 million across 17 hospitals. Seven hospitals generated a profit for mental health and suicide attempt admissions; 10 hospitals reported losses. Only three hospitals generated a higher net profit for mental health admissions than for other medical admissions. More hospitals had net profits for inpatient status mental health and suicide attempt admissions than for observation status mental health and suicide attempt admissions.

For a minority of children’s hospitals, mental health hospitalizations had higher profit margins than for other medical hospitalizations. This raises questions about patient outcomes and the type of care models employed. One potential explanation is that these hospitals have negotiated favorable agreements with payers. Another possibility could be variations in case-mix and payer mix. Certain mental health services, such as crisis response teams, social workers, and child life specialists, may also be funded from nonpayer sources, so estimates may not fully reflect the cost of providing mental health services. A worst-case view is that hospitals with higher profit margins are providing less or poorer care because of lower reimbursement.

Mental health and suicide attempt hospitalizations were associated with smaller margins but counterintuitively generally wider IQRs for cost. This might be related to variation in care models, but our study was not positioned to examine reasons for this variation. The relationship between reimbursement or margins and patient outcomes, as well as specific mechanisms which may drive costs and outcomes, are areas for future research.

Health insurance plays a crucial role in mental health care. In our study, hospitals were more likely to report positive margins from inpatient status mental health hospitalizations rather than from observation status ones. This is unsurprising because payments for observation status are generally lower than for inpatient status.¹² Less is known about what influences billing and payment for inpatient versus observation at individual hospitals, particularly for mental health hospitalizations. In many cases, billing status is not strictly under the hospital’s control and may be determined by payers during or after the hospitalization. Significant variability in the percentage of patients billed as observation status and the impact of lower, often negative, margins for observation mental health encounters, will have a disproportionate effect on some hospitals. Future work could investigate how these differences may influence overall costs and delivery of care.

This study has several limitations that deserve attention. Costs reported are based on cost to charge ratios, which may generate imperfect estimates. Data was limited to 17 freestanding children’s hospitals, and our findings may not generalize to other hospitals. We also compared mental health and suicide attempt hospitalizations with “other medical” hospitalizations. This broad group contains certain medical conditions that may have higher or lower profit margins than average, and estimates of the margins could be over- or underestimated. We assumed that mental health and suicide attempt admissions were displacing admissions with non–mental health medical conditions (ie, not an empty bed). If those beds would otherwise be unoccupied, raw margins are better estimates of the financial impact than margin differences between mental health/suicide attempt and other medical hospitalizations.

Children’s hospitals are more likely to have significantly lower financial margins for mental health and suicide attempt hospitalizations than for other medical hospitalizations. Future work to investigate how quality of care is associated with reimbursement can help ensure that funding for children’s acute mental health care services is commensurate with resources required to provide high quality services.

The authors had no financial relationships relevant to this article to disclose.

Research reported in this publication was supported by the National Institute of Mental Health of the National Institutes of Health under Award Number K23MH115162 (Doupnik).

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Increasing numbers of children and adolescents are presenting to children’s hospitals with acute mental health crises requiring emergent or inpatient treatment.^1-5 As a result, children’s hospitals are experiencing additional financial challenges because specialty mental health services are often reimbursed at lower rates than other medical services.^6-9 Poor reimbursement has also been cited as a deterrent to the provision of mental health specialty care, including emergency mental health crisis services.¹⁰ The cumulative financial impact of recent trends in the provision of mental health crisis services at children’s hospitals, however, is unknown. We conducted this study to assess children’s hospitals’ costs, reimbursement, and net profits or losses when delivering inpatient mental health care.

We conducted a retrospective cohort study of the Children’s Hospital Association’s Pediatric Health Information System (PHIS) and Revenue Management Program (RMP) databases. PHIS is an administrative and billing database that collects International Classification of Disease, 10th Revision (ICD-10) diagnoses, procedure codes, and hospital charges from encounters at 52 US children’s hospitals. Costs are estimated from charges using hospital-, year-, and department-specific cost-to-charge ratios. The RMP database is an add-on module to the PHIS database that captures reimbursement data submitted quarterly from 17 participating hospitals based on actual reimbursement amounts collected for each encounter.

Among the 17 participating hospitals, we included all medical (ie, not surgical or intensive care) encounters during calendar year 2017 for children older than 6 years. We stratified encounters into three diagnosis types: primary mental health diagnosis,⁵ suicide attempt,¹¹ or other medical hospitalizations. We separated suicide attempts since these encounters often require care for both mental health concerns and medical complications. Eating disorders were excluded because these programs at children’s hospitals primarily focus on medical complications, require complex multispecialty support, have significantly longer hospitalizations and made up a small volume of overall mental health hospitalizations.

We stratified all analyses by inpatient or observation encounter and determined the proportion of encounters and hospital days attributed to primary mental health, suicide attempt, and other medical conditions at each hospital. One of the 17 children’s hospitals does not use observation status billing, so the observation encounters dataset includes 16 hospitals.

We summarized patients’ demographic and clinical characteristics using frequencies and percentages, comparing across diagnosis groups using chi-square tests. We calculated mean cost per day as (total cost) ÷ (total length of stay [LOS]), reimbursement per day as (total reimbursement) ÷ (total LOS) for each hospital and patient group, and margin per day as (reimbursement per day) – (cost per day). We then determined the total margin difference of caring for mental health vs caring for other medical encounters as ([margin per day for mental health] – [margin per day other medical]) × (number of mental health days). Similarly, we calculated the total margin loss for suicide attempts vs other medical encounters. After calculating profits and losses at individual hospitals, we summed total annual profits and losses to calculate cumulative annual differences. We summarized these profits and losses across all hospitals with medians and interquartile ranges (IQR).

This study of deidentified administrative data was approved by the Internal Review Board at Vanderbilt University as non-human subjects research. All statistical analyses were performed using SAS v.9.4 (SAS Institute, Cary, North Carolina), and P values < .05 were considered statistically significant.

Study Population

Across the 17 included children’s hospitals, there were 8,521 (7.6%) mental health encounters, 3,247 (2.9%) suicide attempt encounters, and 99,937 (89.5%) other medical encounters. LOS was significantly longer for mental health hospitalizations than for suicide attempts and for other medical hospitalizations.

Hospital Characteristics

All 17 free-standing children’s hospitals in the study had an inpatient behavioral health/psychiatric consultation service, and 7 of the 17 had an inpatient behavioral health/psychiatric unit. The total number of discharges for mental health, suicide attempt, and other medical conditions per year varied (range, 2,868-13,214) across the hospitals.

Hospital Daily Profits and Losses for Mental Health, Suicide Attempt, and Other Medical Admissions

For inpatient status mental health hospitalizations, the median margin was $376/day (IQR, $23-$618). For inpatient status suicide attempt hospitalizations, the median margin was $685/day (IQR, $3-$1,117), and for other medical hospitalizations the median margin was $603/day (IQR, $240-$991). With regard to observation status admissions, mental health hospitalizations had a median margin of –$453/day (IQR, –$806 to $362), suicide attempts of –$103/day (IQR, –$639 to $264), and other medical conditions of $353/day (IQR, –$616 to $658; Figure).

Hospital Annual Profits and Losses for Mental Health and Suicide Attempt Admissions, Compared With Other Medical Admissions

The Table shows daily and annual profits and losses for inpatient and observation status. The total annual loss across all hospitals for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, including both inpatient and observation status, was –$26,658,255 when taking both profits and losses into account. For the seven hospitals with net profits for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, the median net profit for combined inpatient and observation status encounters was $119,361 (IQR, $82,818-$195,543), and the total net profit was $5,872,665. For the 10 hospitals with net losses for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, the median net loss for combined inpatient and observation status was –$2,169,357 (IQR, –$4,034,085 to –$511,755), and the total net loss was –$27,419,379.

Hospitalizations for mental health disorders and suicide attempts accounted for 10.5% of hospitalizations at 17 US children’s hospitals in 2017. Overall, mental health and suicide attempt hospitalizations had lower financial margins than did other medical hospitalizations, and they accounted for a total margin loss of more than $26 million across 17 hospitals. Seven hospitals generated a profit for mental health and suicide attempt admissions; 10 hospitals reported losses. Only three hospitals generated a higher net profit for mental health admissions than for other medical admissions. More hospitals had net profits for inpatient status mental health and suicide attempt admissions than for observation status mental health and suicide attempt admissions.

For a minority of children’s hospitals, mental health hospitalizations had higher profit margins than for other medical hospitalizations. This raises questions about patient outcomes and the type of care models employed. One potential explanation is that these hospitals have negotiated favorable agreements with payers. Another possibility could be variations in case-mix and payer mix. Certain mental health services, such as crisis response teams, social workers, and child life specialists, may also be funded from nonpayer sources, so estimates may not fully reflect the cost of providing mental health services. A worst-case view is that hospitals with higher profit margins are providing less or poorer care because of lower reimbursement.

Mental health and suicide attempt hospitalizations were associated with smaller margins but counterintuitively generally wider IQRs for cost. This might be related to variation in care models, but our study was not positioned to examine reasons for this variation. The relationship between reimbursement or margins and patient outcomes, as well as specific mechanisms which may drive costs and outcomes, are areas for future research.

Health insurance plays a crucial role in mental health care. In our study, hospitals were more likely to report positive margins from inpatient status mental health hospitalizations rather than from observation status ones. This is unsurprising because payments for observation status are generally lower than for inpatient status.¹² Less is known about what influences billing and payment for inpatient versus observation at individual hospitals, particularly for mental health hospitalizations. In many cases, billing status is not strictly under the hospital’s control and may be determined by payers during or after the hospitalization. Significant variability in the percentage of patients billed as observation status and the impact of lower, often negative, margins for observation mental health encounters, will have a disproportionate effect on some hospitals. Future work could investigate how these differences may influence overall costs and delivery of care.

This study has several limitations that deserve attention. Costs reported are based on cost to charge ratios, which may generate imperfect estimates. Data was limited to 17 freestanding children’s hospitals, and our findings may not generalize to other hospitals. We also compared mental health and suicide attempt hospitalizations with “other medical” hospitalizations. This broad group contains certain medical conditions that may have higher or lower profit margins than average, and estimates of the margins could be over- or underestimated. We assumed that mental health and suicide attempt admissions were displacing admissions with non–mental health medical conditions (ie, not an empty bed). If those beds would otherwise be unoccupied, raw margins are better estimates of the financial impact than margin differences between mental health/suicide attempt and other medical hospitalizations.

Children’s hospitals are more likely to have significantly lower financial margins for mental health and suicide attempt hospitalizations than for other medical hospitalizations. Future work to investigate how quality of care is associated with reimbursement can help ensure that funding for children’s acute mental health care services is commensurate with resources required to provide high quality services.

The authors had no financial relationships relevant to this article to disclose.

Research reported in this publication was supported by the National Institute of Mental Health of the National Institutes of Health under Award Number K23MH115162 (Doupnik).

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Increasing numbers of children and adolescents are presenting to children’s hospitals with acute mental health crises requiring emergent or inpatient treatment.^1-5 As a result, children’s hospitals are experiencing additional financial challenges because specialty mental health services are often reimbursed at lower rates than other medical services.^6-9 Poor reimbursement has also been cited as a deterrent to the provision of mental health specialty care, including emergency mental health crisis services.¹⁰ The cumulative financial impact of recent trends in the provision of mental health crisis services at children’s hospitals, however, is unknown. We conducted this study to assess children’s hospitals’ costs, reimbursement, and net profits or losses when delivering inpatient mental health care.

We conducted a retrospective cohort study of the Children’s Hospital Association’s Pediatric Health Information System (PHIS) and Revenue Management Program (RMP) databases. PHIS is an administrative and billing database that collects International Classification of Disease, 10th Revision (ICD-10) diagnoses, procedure codes, and hospital charges from encounters at 52 US children’s hospitals. Costs are estimated from charges using hospital-, year-, and department-specific cost-to-charge ratios. The RMP database is an add-on module to the PHIS database that captures reimbursement data submitted quarterly from 17 participating hospitals based on actual reimbursement amounts collected for each encounter.

Among the 17 participating hospitals, we included all medical (ie, not surgical or intensive care) encounters during calendar year 2017 for children older than 6 years. We stratified encounters into three diagnosis types: primary mental health diagnosis,⁵ suicide attempt,¹¹ or other medical hospitalizations. We separated suicide attempts since these encounters often require care for both mental health concerns and medical complications. Eating disorders were excluded because these programs at children’s hospitals primarily focus on medical complications, require complex multispecialty support, have significantly longer hospitalizations and made up a small volume of overall mental health hospitalizations.

We stratified all analyses by inpatient or observation encounter and determined the proportion of encounters and hospital days attributed to primary mental health, suicide attempt, and other medical conditions at each hospital. One of the 17 children’s hospitals does not use observation status billing, so the observation encounters dataset includes 16 hospitals.

We summarized patients’ demographic and clinical characteristics using frequencies and percentages, comparing across diagnosis groups using chi-square tests. We calculated mean cost per day as (total cost) ÷ (total length of stay [LOS]), reimbursement per day as (total reimbursement) ÷ (total LOS) for each hospital and patient group, and margin per day as (reimbursement per day) – (cost per day). We then determined the total margin difference of caring for mental health vs caring for other medical encounters as ([margin per day for mental health] – [margin per day other medical]) × (number of mental health days). Similarly, we calculated the total margin loss for suicide attempts vs other medical encounters. After calculating profits and losses at individual hospitals, we summed total annual profits and losses to calculate cumulative annual differences. We summarized these profits and losses across all hospitals with medians and interquartile ranges (IQR).

This study of deidentified administrative data was approved by the Internal Review Board at Vanderbilt University as non-human subjects research. All statistical analyses were performed using SAS v.9.4 (SAS Institute, Cary, North Carolina), and P values < .05 were considered statistically significant.

Study Population

Across the 17 included children’s hospitals, there were 8,521 (7.6%) mental health encounters, 3,247 (2.9%) suicide attempt encounters, and 99,937 (89.5%) other medical encounters. LOS was significantly longer for mental health hospitalizations than for suicide attempts and for other medical hospitalizations.

Hospital Characteristics

All 17 free-standing children’s hospitals in the study had an inpatient behavioral health/psychiatric consultation service, and 7 of the 17 had an inpatient behavioral health/psychiatric unit. The total number of discharges for mental health, suicide attempt, and other medical conditions per year varied (range, 2,868-13,214) across the hospitals.

Hospital Daily Profits and Losses for Mental Health, Suicide Attempt, and Other Medical Admissions

For inpatient status mental health hospitalizations, the median margin was $376/day (IQR, $23-$618). For inpatient status suicide attempt hospitalizations, the median margin was $685/day (IQR, $3-$1,117), and for other medical hospitalizations the median margin was $603/day (IQR, $240-$991). With regard to observation status admissions, mental health hospitalizations had a median margin of –$453/day (IQR, –$806 to $362), suicide attempts of –$103/day (IQR, –$639 to $264), and other medical conditions of $353/day (IQR, –$616 to $658; Figure).

Hospital Annual Profits and Losses for Mental Health and Suicide Attempt Admissions, Compared With Other Medical Admissions

The Table shows daily and annual profits and losses for inpatient and observation status. The total annual loss across all hospitals for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, including both inpatient and observation status, was –$26,658,255 when taking both profits and losses into account. For the seven hospitals with net profits for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, the median net profit for combined inpatient and observation status encounters was $119,361 (IQR, $82,818-$195,543), and the total net profit was $5,872,665. For the 10 hospitals with net losses for mental health and suicide attempt hospitalizations, compared with other medical hospitalizations, the median net loss for combined inpatient and observation status was –$2,169,357 (IQR, –$4,034,085 to –$511,755), and the total net loss was –$27,419,379.

Hospitalizations for mental health disorders and suicide attempts accounted for 10.5% of hospitalizations at 17 US children’s hospitals in 2017. Overall, mental health and suicide attempt hospitalizations had lower financial margins than did other medical hospitalizations, and they accounted for a total margin loss of more than $26 million across 17 hospitals. Seven hospitals generated a profit for mental health and suicide attempt admissions; 10 hospitals reported losses. Only three hospitals generated a higher net profit for mental health admissions than for other medical admissions. More hospitals had net profits for inpatient status mental health and suicide attempt admissions than for observation status mental health and suicide attempt admissions.

For a minority of children’s hospitals, mental health hospitalizations had higher profit margins than for other medical hospitalizations. This raises questions about patient outcomes and the type of care models employed. One potential explanation is that these hospitals have negotiated favorable agreements with payers. Another possibility could be variations in case-mix and payer mix. Certain mental health services, such as crisis response teams, social workers, and child life specialists, may also be funded from nonpayer sources, so estimates may not fully reflect the cost of providing mental health services. A worst-case view is that hospitals with higher profit margins are providing less or poorer care because of lower reimbursement.

Mental health and suicide attempt hospitalizations were associated with smaller margins but counterintuitively generally wider IQRs for cost. This might be related to variation in care models, but our study was not positioned to examine reasons for this variation. The relationship between reimbursement or margins and patient outcomes, as well as specific mechanisms which may drive costs and outcomes, are areas for future research.

Health insurance plays a crucial role in mental health care. In our study, hospitals were more likely to report positive margins from inpatient status mental health hospitalizations rather than from observation status ones. This is unsurprising because payments for observation status are generally lower than for inpatient status.¹² Less is known about what influences billing and payment for inpatient versus observation at individual hospitals, particularly for mental health hospitalizations. In many cases, billing status is not strictly under the hospital’s control and may be determined by payers during or after the hospitalization. Significant variability in the percentage of patients billed as observation status and the impact of lower, often negative, margins for observation mental health encounters, will have a disproportionate effect on some hospitals. Future work could investigate how these differences may influence overall costs and delivery of care.

This study has several limitations that deserve attention. Costs reported are based on cost to charge ratios, which may generate imperfect estimates. Data was limited to 17 freestanding children’s hospitals, and our findings may not generalize to other hospitals. We also compared mental health and suicide attempt hospitalizations with “other medical” hospitalizations. This broad group contains certain medical conditions that may have higher or lower profit margins than average, and estimates of the margins could be over- or underestimated. We assumed that mental health and suicide attempt admissions were displacing admissions with non–mental health medical conditions (ie, not an empty bed). If those beds would otherwise be unoccupied, raw margins are better estimates of the financial impact than margin differences between mental health/suicide attempt and other medical hospitalizations.

Children’s hospitals are more likely to have significantly lower financial margins for mental health and suicide attempt hospitalizations than for other medical hospitalizations. Future work to investigate how quality of care is associated with reimbursement can help ensure that funding for children’s acute mental health care services is commensurate with resources required to provide high quality services.

The authors had no financial relationships relevant to this article to disclose.

Research reported in this publication was supported by the National Institute of Mental Health of the National Institutes of Health under Award Number K23MH115162 (Doupnik).

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.