I am a former military psychiatrist who has published extensively about posttraumatic stress disorder and other psychological effects of war. Thus, I got sent the news clips many times about a potential candidate for mayor of Kansas City leaving the race to care for himself, his depression, and posttraumatic stress disorder symptoms.

Like many of our readers who are physicians, I have a very mixed response to the former candidate’s news.

On the one hand, kudos to him that he has decided to 1) get the help he says he needs, and 2) go public. On the other hand, I really wish that he did not have to drop out of the race to do so.

There are some parallels with leaving for severe physical illness, such as getting chemotherapy for cancer. However, for example, when Gov. Larry Hogan of Maryland received treatment for his cancer, he stayed in office.

Why can you stay in a race or office with cancer or heart disease but not with the very common psychiatric and treatable condition of PTSD?

I certainly do not know all the reasons the candidate for Kansas City mayor made this decision. He said he is encouraging other veterans to follow his example and get treatment for PTSD. He also alluded to suicidal ideation.

This got me thinking about the concept of needing to leave work to take care of yourself – a decision that is often lauded as both noble and wise. I will not opine much on nobility, other than saying it is always noble to help fellow veterans. Maybe his decision to go public will help other veterans. Hard to say. But I can on opine on wisdom, based on many years of working with veterans with PTSD. I almost always advise them to keep their jobs, if at all possible.

Taking time off from a job you care for actually might increase suicidal thoughts. That is due to less structure in the day, less socialization, and fewer feelings of self-worth. A consequent lack of funds might not help. I have long called holding a good job one of the best mental health interventions, superior to medicine and therapy alone (OK – I am being doctrinaire; there are no placebo-controlled, double blind trials on the topic. But I am also serious.)

In general, when folks with mental illness leave the workforce, it can be very hard to get back in. Why do we need to choose one or the other? Why not both? Why is it work or saving oneself? In my opinion, work helps to save oneself. Helping others, for most veterans, is a lifeline.

I wonder why he should have to drop out of work to receive treatment. Perhaps he was placed in a residential Veterans Affairs program, which often are 30-60 days long. It is notoriously hard to maintain a job during such treatment.

I believe that we should structure our PTSD therapy so that one can both work and receive appropriate treatment. We need war veterans, with or without PTSD, to run for office. And win.

Dr. Ritchie is chief of psychiatry at MedStar Washington Hospital Center.

I am a former military psychiatrist who has published extensively about posttraumatic stress disorder and other psychological effects of war. Thus, I got sent the news clips many times about a potential candidate for mayor of Kansas City leaving the race to care for himself, his depression, and posttraumatic stress disorder symptoms.

Like many of our readers who are physicians, I have a very mixed response to the former candidate’s news.

On the one hand, kudos to him that he has decided to 1) get the help he says he needs, and 2) go public. On the other hand, I really wish that he did not have to drop out of the race to do so.

There are some parallels with leaving for severe physical illness, such as getting chemotherapy for cancer. However, for example, when Gov. Larry Hogan of Maryland received treatment for his cancer, he stayed in office.

Why can you stay in a race or office with cancer or heart disease but not with the very common psychiatric and treatable condition of PTSD?

I certainly do not know all the reasons the candidate for Kansas City mayor made this decision. He said he is encouraging other veterans to follow his example and get treatment for PTSD. He also alluded to suicidal ideation.

This got me thinking about the concept of needing to leave work to take care of yourself – a decision that is often lauded as both noble and wise. I will not opine much on nobility, other than saying it is always noble to help fellow veterans. Maybe his decision to go public will help other veterans. Hard to say. But I can on opine on wisdom, based on many years of working with veterans with PTSD. I almost always advise them to keep their jobs, if at all possible.

Taking time off from a job you care for actually might increase suicidal thoughts. That is due to less structure in the day, less socialization, and fewer feelings of self-worth. A consequent lack of funds might not help. I have long called holding a good job one of the best mental health interventions, superior to medicine and therapy alone (OK – I am being doctrinaire; there are no placebo-controlled, double blind trials on the topic. But I am also serious.)

In general, when folks with mental illness leave the workforce, it can be very hard to get back in. Why do we need to choose one or the other? Why not both? Why is it work or saving oneself? In my opinion, work helps to save oneself. Helping others, for most veterans, is a lifeline.

I wonder why he should have to drop out of work to receive treatment. Perhaps he was placed in a residential Veterans Affairs program, which often are 30-60 days long. It is notoriously hard to maintain a job during such treatment.

I believe that we should structure our PTSD therapy so that one can both work and receive appropriate treatment. We need war veterans, with or without PTSD, to run for office. And win.

Dr. Ritchie is chief of psychiatry at MedStar Washington Hospital Center.

I am a former military psychiatrist who has published extensively about posttraumatic stress disorder and other psychological effects of war. Thus, I got sent the news clips many times about a potential candidate for mayor of Kansas City leaving the race to care for himself, his depression, and posttraumatic stress disorder symptoms.

Like many of our readers who are physicians, I have a very mixed response to the former candidate’s news.

On the one hand, kudos to him that he has decided to 1) get the help he says he needs, and 2) go public. On the other hand, I really wish that he did not have to drop out of the race to do so.

There are some parallels with leaving for severe physical illness, such as getting chemotherapy for cancer. However, for example, when Gov. Larry Hogan of Maryland received treatment for his cancer, he stayed in office.

Why can you stay in a race or office with cancer or heart disease but not with the very common psychiatric and treatable condition of PTSD?

I certainly do not know all the reasons the candidate for Kansas City mayor made this decision. He said he is encouraging other veterans to follow his example and get treatment for PTSD. He also alluded to suicidal ideation.

This got me thinking about the concept of needing to leave work to take care of yourself – a decision that is often lauded as both noble and wise. I will not opine much on nobility, other than saying it is always noble to help fellow veterans. Maybe his decision to go public will help other veterans. Hard to say. But I can on opine on wisdom, based on many years of working with veterans with PTSD. I almost always advise them to keep their jobs, if at all possible.

Taking time off from a job you care for actually might increase suicidal thoughts. That is due to less structure in the day, less socialization, and fewer feelings of self-worth. A consequent lack of funds might not help. I have long called holding a good job one of the best mental health interventions, superior to medicine and therapy alone (OK – I am being doctrinaire; there are no placebo-controlled, double blind trials on the topic. But I am also serious.)

In general, when folks with mental illness leave the workforce, it can be very hard to get back in. Why do we need to choose one or the other? Why not both? Why is it work or saving oneself? In my opinion, work helps to save oneself. Helping others, for most veterans, is a lifeline.

I wonder why he should have to drop out of work to receive treatment. Perhaps he was placed in a residential Veterans Affairs program, which often are 30-60 days long. It is notoriously hard to maintain a job during such treatment.

I believe that we should structure our PTSD therapy so that one can both work and receive appropriate treatment. We need war veterans, with or without PTSD, to run for office. And win.

Dr. Ritchie is chief of psychiatry at MedStar Washington Hospital Center.

A proposal would eliminate incident to billing which is a payment policy under which an APRN or PA delivers the care, but the claim is filed under a physician’s NPI and is paid via Medicare physician fee schedule rate. Also today, stepping down to oral ciprofloxacin looks safe in gram-negative bloodstream infections, a nasal cannula device may be an option for severe COPD, and brexanolone injection quickly improves postpartum depression.

A proposal would eliminate incident to billing which is a payment policy under which an APRN or PA delivers the care, but the claim is filed under a physician’s NPI and is paid via Medicare physician fee schedule rate. Also today, stepping down to oral ciprofloxacin looks safe in gram-negative bloodstream infections, a nasal cannula device may be an option for severe COPD, and brexanolone injection quickly improves postpartum depression.

A proposal would eliminate incident to billing which is a payment policy under which an APRN or PA delivers the care, but the claim is filed under a physician’s NPI and is paid via Medicare physician fee schedule rate. Also today, stepping down to oral ciprofloxacin looks safe in gram-negative bloodstream infections, a nasal cannula device may be an option for severe COPD, and brexanolone injection quickly improves postpartum depression.

Chronic diseases affect a substantial proportion of the US population, with 25% of adults diagnosed with 2 or more chronic health conditions.¹ In 2010, 2 chronic diseases, heart disease and cancer, accounted for nearly 48% of deaths.² Due to the significant public heath burden, strategies to improve chronic disease management have attracted a great deal of focus.^3,4 Within increasingly complex health care delivery systems, policy makers are promoting care coordination (CC) as a tool to reduce fragmented care for patients with multiple comorbidities, improve patient experience and quality of care, and decrease costs and risks for error.^3-8

Background

The Agency for Healthcare Research and Quality (AHRQ) defines care coordination as “deliberately organizing patient care activities and sharing information among all of the participants concerned with a patient’s care to achieve safer and more effective care.”⁵ Nationally, large scale investments have expanded health care models that provide team-based CC, such as patient-centered medical homes, known as patient-aligned care teams (PACTs) within the Department of Veterans Affairs (VA), accountable care organizations, and other complex care management programs.^9-12 Additionally, incentives that reimburse for CC, such as Medicare’s chronic care management and transition care management billing codes, also are emerging.^13,14

While there is significant interest and investment in promoting CC, little data about the specific activities and time required to provide necessary CC exist, which limits the ability of health care teams to optimize CC delivery.⁶ Understanding the components of CC has implications for human resource allocation, labor mapping, reimbursement, staff training, and optimizing collaborative networks for health care systems, which may improve the quality of CC and health outcomes for patients. To date, few tools exist that can be used to identify and track the CC services delivered by interdisciplinary teams within and outside of the health care setting. 

This article describes the development and preliminary results of the implementation of a CC Template that was created in the VA Computerized Patient Record System (CPRS) to identify and track the components of CC services, delivered by a multidisciplinary team, as part of a quality improvement (QI) pilot project. Through use of the template, the team sought a formative understanding of the following questions: (1) Is it feasible to use the CC Template during routine workflow? (2) What specific types of CC services are provided by the team? (3) How much time does it take to perform these activities? (4) Who is the team collaborating with inside and outside of the health care setting and how are they communicating? (5) Given new reimbursement incentives, can the provision of CC be standardized and documented for broad applicability?

In complex systems, where coordination is needed among primary, specialty, hospital, emergency, and nonclinical care settings, a tool such as the CC Template offers a sustainable and replicable way to standardize documentation and knowledge about CC components. This foundational information can be used to optimize team structure, training, and resource allocation, to improve the quality of CC and to link elements of CC with clinical and operational outcomes.

Pact Intensive Management

Despite the implementation of PACT within VA, patients with complex medical conditions combined with socioeconomic stressors, mental health comorbidities, and low health literacy are at high risk for preventable hospitalizations and acute care utilization.^17,18 Due to unmet needs that are beyond what PACTs are able to deliver, these high-risk patients may benefit from additional services to coordinate care within and outside the VA health care system, as suggest by the Extended Chronic Care Model.^19-21

In 2014, the Office of Primary Care Services sponsored a QI initiative at 5 VA demonstration sites to develop PACT Intensive Management (PIM) interventions targeting patients at high risk for hospitalization and acute care utilization within VA. The PIM program design is based on work described previously, with patients identified for enrollment based on 90-day hospitalization risk ≥ 90th percentile, based on a VA risk modeling tool, and an acute care episode in the previous 6 months. ¹⁹ A common component of all PIM programs is the provision of intensive care management and CC by an interdisciplinary team working in conjunction with PACT. The CC Template was developed to assist in documenting and rigorously understanding the implementation of CC by the PIM team.

Local Setting

The Atlanta VA Medical Center (AVAMC) was chosen as one of the PIM demonstration sites. The Atlanta PIM team identified and enrolled a random sample of eligible, high-risk patients from 1 community-based outpatient clinic (CBOC) in an urban location with 7,524 unique patients. Between September 2014 and September 2016, 300 patients were identified, and 86 patients agreed to participate in the PIM program.

In the CC Template pilot, the Atlanta PIM team included 2 nurse practitioners (NP), 2 social workers (SW), and 1 telehealth registered nurse (RN). Upon enrollment, members of the PIM team conducted comprehensive home assessments and offered intensive care management for medical, social, and behavioral needs. The main pillars of care management offered to high-risk patients were based on previous work done both inside and outside VA and included home visits, telephone-based disease management, co-attending appointments with patients, transition care management, and interdisciplinary team meetings with a focus on care coordination between PACT and all services required by patients.^11,19

The Atlanta PIM team performed a variety of tasks to coordinate care for enrolled patients that included simple, 1-step tasks, such as chart reviews, and multistep, complex tasks that required the expertise of multiple team members (Figure 1). 

Additionally, inconsistency in delivery of CC between PIM team members was noted. For example, there was significant variability in CC services provided by different team members in the provision of transition care management (TCM) and coordinating care from hospitalization back to home. Some PIM staff coordinated care and communicated with the patient, hospital team, home-care service, and primary-care team, while other staff only reviewed the chart and placed orders in CPRS. Additionally, much of the CC work was documented in administrative notes that did not trigger workload credit. This made it difficult to show how to appropriately labor map PIM staff or how staff were spending their time caring for patients.

In order to standardize documentation of the interdisciplinary CC activities performed by the PIM team and account for staff time, the Atlanta PIM team decided to develop a CPRS CC Template. The objective of the CC Template was to facilitate documentation of CC activities in the EHR, describe the types of CC activities performed by PIM team members, and track the time to perform these activities for patients with various chronic diseases.

Template Design and Implementation

The original design of the template was informed by the Atlanta PIM team after several informal focus groups and process mapping of CC pathways in the fall of 2015. The participants were all members of the Atlanta PIM team, 2 primary care physicians working with PIM, an AVAMC documentation specialist and a clinical applications coordinator (CAC) assigned to work with PIM. The major themes that arose during the brainstorming discussion were that the template should: (1) be feasible to use during their daily clinic workflow; (2) improve documentation of CC; and (3) have value for spread to other VA sites. Discussion centered on creating a CC Template versatile enough to:

• Decrease the number of steps for documenting CC;
• Consist only of check boxes, with very little need for free text, with the option to enter narrative free text after template completion;
• Document time spent in aggregate for completing complex CC encounters;
• Document various types of CC work and modes of communication;
• Allow for use by all PIM staff;
• Identify all team members that participated in the CC encounter to reduce redundant documentation by multiple staff;
• Adapt to different clinic sites based on the varied disciplines participating in other locations;
• Use evidence-based checklists to help standardize delivery of CC for certain activities such as TCM; and
• Extract data without extensive chart reviews to inform current CC and future QI work.

Following the brainstorming sessions, the authors performed a literature review to identify and integrate CC best practices. The AHRQ Care Coordination Atlas served as the main resource in the design of the logic model that depicted the delivery and subsequent documentation of high-quality, evidence-based CC in the CC Template (Figure 2).⁶ 

After reaching consensus about the key components of the CC Template, the CAC created a pilot version (Figure 3). All of the elements within the CC Template allowed for data abstraction from the VA Corporate Data Warehouse (CDW) via discrete data elements known as health factors. 

Over the course of implementation, the team became more enthusiastic about using the CC template to document previously unrecognized CC workload. Because the CC Template only was used to document CC workload and excluded encounters for clinical evaluation and management, specific notes were created and linked with the CC Template for optimal capture of encounters.

All components of the template were mandatory to eliminate the possibility of missing data. The Atlanta PIM site principal investigator developed a multicomponent training designed to increase support for the template by describing its value and to mitigate the potential for variability in how data are captured. Training included a face-to-face session with the team to review the template and work through sample CC cases. Additionally, a training manual with clear operational definitions and examples of how to complete each element of the CC Template was disseminated. The training was subsequently conducted with the San Francisco VA Medical Center PIM team, a spread site, via video conference. The spread site offered significant feedback on clarifying the training documents and adapting the CC template for their distinct care team structure. This feedback was incorporated into the final CC Template design to increase adaptability.

Implementation Evaluation

The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)framework served as the basis for evaluation of CC Template implementation. The RE-AIM framework is well established and able to evaluate the implementation and potential successful spread of new programs.^23,24 Using RE-AIM, the authors planned to analyze data to explore the reach effectiveness, adoption, implementation, and maintenance of the CC Template use while providing complex care management for high-risk patients.

All data for the evaluation was extracted from the CDW by a data analyst and stored on a secure server. A statistical process control (SPC) chart was used to analyze the implementation process to assess variation in template use.

Results

After implementation, 35 weeks of CC Template pilot data were analyzed from June 1, 2015 to January 5, 2016. The PIM team completed 393 CC Templates over this collection period. After week 23, the CC template was linked to specific CC notes automatically. From weeks 23 to 35 an average of 20.3 CC Templates were completed per week by the team. The RE-AIM was used to assess the implementation of the CC Template.

Reach was determined by the number of patients enrolled in PIM with CC Template documentation. Of patients enrolled in Atlanta PIM, 90.1% had ≥ 1 CC encounter documented by the CC Template; 74.4% of Atlanta PIM patients had ≥ 1 CC encounter documented; 15.5% of patients had > 10 CC encounters documented; and 1 patient had > 25 CC encounters documented by the CC template.

Effectiveness for describing CC activities was captured through data from CC Template. The CC Template documentation by the PIM team showed that 79.4% of CC encounters were < 20 minutes, and 9.9% of encounters were > 61 minutes. Telephone communication was involved in 50.4% of CC encounters, and 24% required multiple modes of communication such as face-to-face, instant messenger, chart-based communication. Care coordination during hospitalization and discharge accounted for 5.9% of template use. Of the CC encounters documenting hospital transitions, 94.4% documented communication with the inpatient team, 58.3% documented coordination with social support, and only 11.1% documented communication with primary care teams. Improving communication with PACT teams after hospital discharge was identified as a future QI project based on these data. The PIM team initiated 83.2% of CC encounters.

Adoption was determined by the use of the CC Template by the team. All 5 team members used the CC template to document at least 1 CC encounter.

Implementation allowed for improvement based on feedback from the PIM team. Mean completion of CC Templates rose from 10.9 per week to 20.3 per week after automatically linking the CC Template to specific CC notes. (Figure 4)

Maintenance was monitored over the course of the pilot. Consistent use of the CC Template over 35 full work weeks of data collection was seen, and mean utilization per week nearly doubled in the latter half of the pilot period.

Because several elements were added to the CC Template over the course of the pilot period, our ability to analyze the data for descriptive statistics about the types of CC services, related diagnoses, collaborators, and PIM staff involved in CC encounters was limited.

Discussion

Though all components of CC encounters could not be assessed during the pilot phase due to continuous improvement of the CC Template, the authors showed that it is feasible to use this tool to document and describe granular details about team-based CC. Pilot data from AVAMC show that the use of the CC Template standardized team CC documentation in a busy clinic setting provided data about the complexity of coordination activities and duration of CC activities. It also informed future CC QI projects, such as improving communication with primary care during the hospital discharge process.

Future evaluation of CC Template data can be used to (1) describe types of CC activities for high-risk PIM patients; (2) quantify the time required to complete CC activities to assist with staff labor mapping; (3) describe staff roles and referrals needed to complete specific CC activities inside and outside VA; (4) describe modes of communication between PIM and collaborators; (5) relate patient demographics and associated diagnoses with quantity of CC encounters; and (6) quantify frequency and time frame of CC after hospitalizations and ED care and subsequent impact on repeat hospitalizations and ED visits. Future research also can explore the link between CC activities and effort with clinical and patient-reported outcomes.

Social network analysis could be used with CC Template data to understand the network of referrals and collaborators involved in the care of a CC team’s patients. This type of analysis would assist teams to strengthen and formalize ties with collaborators as appropriate. For example, if data show that the team frequently collaborates with the cardiology clinic for a large subset of its patients, they may consider creating a CC agreement with formalized modes of communication that would streamline collaboration.

In order to improve the quality of the CC Template and to assess factors that may lead to sustainable use in clinical practice, qualitative assessment through survey, interview, or usability testing with staff would be beneficial to identify strategies to increase its adoption among clinical providers. This type of assessment will add knowledge about the CC Template implementation process, including contextual barriers or facilitators, feasibility of use during day-to-day operations, versatility of template use within construct of team-based care, and overall satisfaction with the template.

Limitations

Though the CC Template offers a large amount of data about the components of CC delivery, the information is based on self-report by staff. Training to ensure that all team members are documenting in the same manner is crucial to maintain the internal validity of the data. The template is limited to the fields currently developed, and future research could explore additional data elements that are critical to include based on feedback from VA staff.

Conclusion

To our knowledge, this VA medical center CC Template is the first tool described in the literature that standardizes and captures data about CC components in the EHR. This pilot data show that the template is feasible for use in a busy clinic setting and can streamline the process for capturing CC data that may otherwise not be documented.

During the pilot phase, the CC template allowed the PIM team to identify a small subset of patients within the PIM complex management who have a high level of CC needs. By identifying these patients, further work can be done to understand the specific needs of these higher utilizers and the types of CC activities required to assist them so that resources can be directed appropriately to that smaller subset. Telephone CC accounted for a large proportion of delivery, which has implications for ensuring that staff have access to mobile phones and EHR capability to document this additional workload. The PIM staff maintained use of the template throughout the pilot period and increased documentation when the CC Template was easily accessible and already linked to their CPRS notes, suggesting that in future implementation, ensuring that the template is linked to notes in use by the care team will be important for successful spread.

Additionally, CC Template data identified gaps in high-quality, evidence-based CC that can be addressed in real time, for example during the discharge process. Data from the CC Template showed that only 11.1% of CC encounters had documentation of communication between the PIM and primary care teams during transitions from hospital to home. Improving communication with PACT teams after hospital discharge was identified as a future PIM QI project based on these data. By improving documentation of CC in the EHR, the resulting information is foundational for future work that can improve the quality of team-based CC; plan staffing, team composition, and labor mapping; determine the cost of CC activities and improve reimbursement in certain settings; and assess outcomes of CC.

This tool has potential for application beyond the PIM team in the VA. The CC Template and training manual is scalable to any setting with team-based CC, including PACT, homeless programs, palliative care, Mental Health Intensive Case Management (MHICM) programs, nurse navigator programs, and other complex care delivery models involving care coordinators. Future study of its implementation and data may inform initiatives to develop ongoing team-based care coordination programs.

Acknowledgments
The authors thank the following colleagues for their input and support: Florence Longchamp, RN, Clinical Applications Coordinator at the Atlanta VA Medical Center without whom the CC Template would not have been created; the Atlanta and San Francisco VA PIM teams for their thoughtful comments and enthusiastic embrace of the CC Template; and the PIM National Evaluation Center for their support of this QI project. PACT Intensive Management demonstration sites are funded by the VA Office of Patient Care Services. During the implementation of the CC Template pilot and the preparation of this paper, the primary author was supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Academic Affiliations, Advanced Fellowships, VA Quality Scholars Program.

Chronic diseases affect a substantial proportion of the US population, with 25% of adults diagnosed with 2 or more chronic health conditions.¹ In 2010, 2 chronic diseases, heart disease and cancer, accounted for nearly 48% of deaths.² Due to the significant public heath burden, strategies to improve chronic disease management have attracted a great deal of focus.^3,4 Within increasingly complex health care delivery systems, policy makers are promoting care coordination (CC) as a tool to reduce fragmented care for patients with multiple comorbidities, improve patient experience and quality of care, and decrease costs and risks for error.^3-8

Background

The Agency for Healthcare Research and Quality (AHRQ) defines care coordination as “deliberately organizing patient care activities and sharing information among all of the participants concerned with a patient’s care to achieve safer and more effective care.”⁵ Nationally, large scale investments have expanded health care models that provide team-based CC, such as patient-centered medical homes, known as patient-aligned care teams (PACTs) within the Department of Veterans Affairs (VA), accountable care organizations, and other complex care management programs.^9-12 Additionally, incentives that reimburse for CC, such as Medicare’s chronic care management and transition care management billing codes, also are emerging.^13,14

While there is significant interest and investment in promoting CC, little data about the specific activities and time required to provide necessary CC exist, which limits the ability of health care teams to optimize CC delivery.⁶ Understanding the components of CC has implications for human resource allocation, labor mapping, reimbursement, staff training, and optimizing collaborative networks for health care systems, which may improve the quality of CC and health outcomes for patients. To date, few tools exist that can be used to identify and track the CC services delivered by interdisciplinary teams within and outside of the health care setting. 

This article describes the development and preliminary results of the implementation of a CC Template that was created in the VA Computerized Patient Record System (CPRS) to identify and track the components of CC services, delivered by a multidisciplinary team, as part of a quality improvement (QI) pilot project. Through use of the template, the team sought a formative understanding of the following questions: (1) Is it feasible to use the CC Template during routine workflow? (2) What specific types of CC services are provided by the team? (3) How much time does it take to perform these activities? (4) Who is the team collaborating with inside and outside of the health care setting and how are they communicating? (5) Given new reimbursement incentives, can the provision of CC be standardized and documented for broad applicability?

In complex systems, where coordination is needed among primary, specialty, hospital, emergency, and nonclinical care settings, a tool such as the CC Template offers a sustainable and replicable way to standardize documentation and knowledge about CC components. This foundational information can be used to optimize team structure, training, and resource allocation, to improve the quality of CC and to link elements of CC with clinical and operational outcomes.

Pact Intensive Management

Despite the implementation of PACT within VA, patients with complex medical conditions combined with socioeconomic stressors, mental health comorbidities, and low health literacy are at high risk for preventable hospitalizations and acute care utilization.^17,18 Due to unmet needs that are beyond what PACTs are able to deliver, these high-risk patients may benefit from additional services to coordinate care within and outside the VA health care system, as suggest by the Extended Chronic Care Model.^19-21

In 2014, the Office of Primary Care Services sponsored a QI initiative at 5 VA demonstration sites to develop PACT Intensive Management (PIM) interventions targeting patients at high risk for hospitalization and acute care utilization within VA. The PIM program design is based on work described previously, with patients identified for enrollment based on 90-day hospitalization risk ≥ 90th percentile, based on a VA risk modeling tool, and an acute care episode in the previous 6 months. ¹⁹ A common component of all PIM programs is the provision of intensive care management and CC by an interdisciplinary team working in conjunction with PACT. The CC Template was developed to assist in documenting and rigorously understanding the implementation of CC by the PIM team.

Local Setting

The Atlanta VA Medical Center (AVAMC) was chosen as one of the PIM demonstration sites. The Atlanta PIM team identified and enrolled a random sample of eligible, high-risk patients from 1 community-based outpatient clinic (CBOC) in an urban location with 7,524 unique patients. Between September 2014 and September 2016, 300 patients were identified, and 86 patients agreed to participate in the PIM program.

In the CC Template pilot, the Atlanta PIM team included 2 nurse practitioners (NP), 2 social workers (SW), and 1 telehealth registered nurse (RN). Upon enrollment, members of the PIM team conducted comprehensive home assessments and offered intensive care management for medical, social, and behavioral needs. The main pillars of care management offered to high-risk patients were based on previous work done both inside and outside VA and included home visits, telephone-based disease management, co-attending appointments with patients, transition care management, and interdisciplinary team meetings with a focus on care coordination between PACT and all services required by patients.^11,19

The Atlanta PIM team performed a variety of tasks to coordinate care for enrolled patients that included simple, 1-step tasks, such as chart reviews, and multistep, complex tasks that required the expertise of multiple team members (Figure 1). 

Additionally, inconsistency in delivery of CC between PIM team members was noted. For example, there was significant variability in CC services provided by different team members in the provision of transition care management (TCM) and coordinating care from hospitalization back to home. Some PIM staff coordinated care and communicated with the patient, hospital team, home-care service, and primary-care team, while other staff only reviewed the chart and placed orders in CPRS. Additionally, much of the CC work was documented in administrative notes that did not trigger workload credit. This made it difficult to show how to appropriately labor map PIM staff or how staff were spending their time caring for patients.

In order to standardize documentation of the interdisciplinary CC activities performed by the PIM team and account for staff time, the Atlanta PIM team decided to develop a CPRS CC Template. The objective of the CC Template was to facilitate documentation of CC activities in the EHR, describe the types of CC activities performed by PIM team members, and track the time to perform these activities for patients with various chronic diseases.

Template Design and Implementation

The original design of the template was informed by the Atlanta PIM team after several informal focus groups and process mapping of CC pathways in the fall of 2015. The participants were all members of the Atlanta PIM team, 2 primary care physicians working with PIM, an AVAMC documentation specialist and a clinical applications coordinator (CAC) assigned to work with PIM. The major themes that arose during the brainstorming discussion were that the template should: (1) be feasible to use during their daily clinic workflow; (2) improve documentation of CC; and (3) have value for spread to other VA sites. Discussion centered on creating a CC Template versatile enough to:

• Decrease the number of steps for documenting CC;
• Consist only of check boxes, with very little need for free text, with the option to enter narrative free text after template completion;
• Document time spent in aggregate for completing complex CC encounters;
• Document various types of CC work and modes of communication;
• Allow for use by all PIM staff;
• Identify all team members that participated in the CC encounter to reduce redundant documentation by multiple staff;
• Adapt to different clinic sites based on the varied disciplines participating in other locations;
• Use evidence-based checklists to help standardize delivery of CC for certain activities such as TCM; and
• Extract data without extensive chart reviews to inform current CC and future QI work.

Following the brainstorming sessions, the authors performed a literature review to identify and integrate CC best practices. The AHRQ Care Coordination Atlas served as the main resource in the design of the logic model that depicted the delivery and subsequent documentation of high-quality, evidence-based CC in the CC Template (Figure 2).⁶ 

After reaching consensus about the key components of the CC Template, the CAC created a pilot version (Figure 3). All of the elements within the CC Template allowed for data abstraction from the VA Corporate Data Warehouse (CDW) via discrete data elements known as health factors. 

Over the course of implementation, the team became more enthusiastic about using the CC template to document previously unrecognized CC workload. Because the CC Template only was used to document CC workload and excluded encounters for clinical evaluation and management, specific notes were created and linked with the CC Template for optimal capture of encounters.

All components of the template were mandatory to eliminate the possibility of missing data. The Atlanta PIM site principal investigator developed a multicomponent training designed to increase support for the template by describing its value and to mitigate the potential for variability in how data are captured. Training included a face-to-face session with the team to review the template and work through sample CC cases. Additionally, a training manual with clear operational definitions and examples of how to complete each element of the CC Template was disseminated. The training was subsequently conducted with the San Francisco VA Medical Center PIM team, a spread site, via video conference. The spread site offered significant feedback on clarifying the training documents and adapting the CC template for their distinct care team structure. This feedback was incorporated into the final CC Template design to increase adaptability.

Implementation Evaluation

The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)framework served as the basis for evaluation of CC Template implementation. The RE-AIM framework is well established and able to evaluate the implementation and potential successful spread of new programs.^23,24 Using RE-AIM, the authors planned to analyze data to explore the reach effectiveness, adoption, implementation, and maintenance of the CC Template use while providing complex care management for high-risk patients.

All data for the evaluation was extracted from the CDW by a data analyst and stored on a secure server. A statistical process control (SPC) chart was used to analyze the implementation process to assess variation in template use.

Results

After implementation, 35 weeks of CC Template pilot data were analyzed from June 1, 2015 to January 5, 2016. The PIM team completed 393 CC Templates over this collection period. After week 23, the CC template was linked to specific CC notes automatically. From weeks 23 to 35 an average of 20.3 CC Templates were completed per week by the team. The RE-AIM was used to assess the implementation of the CC Template.

Reach was determined by the number of patients enrolled in PIM with CC Template documentation. Of patients enrolled in Atlanta PIM, 90.1% had ≥ 1 CC encounter documented by the CC Template; 74.4% of Atlanta PIM patients had ≥ 1 CC encounter documented; 15.5% of patients had > 10 CC encounters documented; and 1 patient had > 25 CC encounters documented by the CC template.

Effectiveness for describing CC activities was captured through data from CC Template. The CC Template documentation by the PIM team showed that 79.4% of CC encounters were < 20 minutes, and 9.9% of encounters were > 61 minutes. Telephone communication was involved in 50.4% of CC encounters, and 24% required multiple modes of communication such as face-to-face, instant messenger, chart-based communication. Care coordination during hospitalization and discharge accounted for 5.9% of template use. Of the CC encounters documenting hospital transitions, 94.4% documented communication with the inpatient team, 58.3% documented coordination with social support, and only 11.1% documented communication with primary care teams. Improving communication with PACT teams after hospital discharge was identified as a future QI project based on these data. The PIM team initiated 83.2% of CC encounters.

Adoption was determined by the use of the CC Template by the team. All 5 team members used the CC template to document at least 1 CC encounter.

Implementation allowed for improvement based on feedback from the PIM team. Mean completion of CC Templates rose from 10.9 per week to 20.3 per week after automatically linking the CC Template to specific CC notes. (Figure 4)

Maintenance was monitored over the course of the pilot. Consistent use of the CC Template over 35 full work weeks of data collection was seen, and mean utilization per week nearly doubled in the latter half of the pilot period.

Because several elements were added to the CC Template over the course of the pilot period, our ability to analyze the data for descriptive statistics about the types of CC services, related diagnoses, collaborators, and PIM staff involved in CC encounters was limited.

Discussion

Though all components of CC encounters could not be assessed during the pilot phase due to continuous improvement of the CC Template, the authors showed that it is feasible to use this tool to document and describe granular details about team-based CC. Pilot data from AVAMC show that the use of the CC Template standardized team CC documentation in a busy clinic setting provided data about the complexity of coordination activities and duration of CC activities. It also informed future CC QI projects, such as improving communication with primary care during the hospital discharge process.

Future evaluation of CC Template data can be used to (1) describe types of CC activities for high-risk PIM patients; (2) quantify the time required to complete CC activities to assist with staff labor mapping; (3) describe staff roles and referrals needed to complete specific CC activities inside and outside VA; (4) describe modes of communication between PIM and collaborators; (5) relate patient demographics and associated diagnoses with quantity of CC encounters; and (6) quantify frequency and time frame of CC after hospitalizations and ED care and subsequent impact on repeat hospitalizations and ED visits. Future research also can explore the link between CC activities and effort with clinical and patient-reported outcomes.

Social network analysis could be used with CC Template data to understand the network of referrals and collaborators involved in the care of a CC team’s patients. This type of analysis would assist teams to strengthen and formalize ties with collaborators as appropriate. For example, if data show that the team frequently collaborates with the cardiology clinic for a large subset of its patients, they may consider creating a CC agreement with formalized modes of communication that would streamline collaboration.

In order to improve the quality of the CC Template and to assess factors that may lead to sustainable use in clinical practice, qualitative assessment through survey, interview, or usability testing with staff would be beneficial to identify strategies to increase its adoption among clinical providers. This type of assessment will add knowledge about the CC Template implementation process, including contextual barriers or facilitators, feasibility of use during day-to-day operations, versatility of template use within construct of team-based care, and overall satisfaction with the template.

Limitations

Though the CC Template offers a large amount of data about the components of CC delivery, the information is based on self-report by staff. Training to ensure that all team members are documenting in the same manner is crucial to maintain the internal validity of the data. The template is limited to the fields currently developed, and future research could explore additional data elements that are critical to include based on feedback from VA staff.

Conclusion

To our knowledge, this VA medical center CC Template is the first tool described in the literature that standardizes and captures data about CC components in the EHR. This pilot data show that the template is feasible for use in a busy clinic setting and can streamline the process for capturing CC data that may otherwise not be documented.

During the pilot phase, the CC template allowed the PIM team to identify a small subset of patients within the PIM complex management who have a high level of CC needs. By identifying these patients, further work can be done to understand the specific needs of these higher utilizers and the types of CC activities required to assist them so that resources can be directed appropriately to that smaller subset. Telephone CC accounted for a large proportion of delivery, which has implications for ensuring that staff have access to mobile phones and EHR capability to document this additional workload. The PIM staff maintained use of the template throughout the pilot period and increased documentation when the CC Template was easily accessible and already linked to their CPRS notes, suggesting that in future implementation, ensuring that the template is linked to notes in use by the care team will be important for successful spread.

Additionally, CC Template data identified gaps in high-quality, evidence-based CC that can be addressed in real time, for example during the discharge process. Data from the CC Template showed that only 11.1% of CC encounters had documentation of communication between the PIM and primary care teams during transitions from hospital to home. Improving communication with PACT teams after hospital discharge was identified as a future PIM QI project based on these data. By improving documentation of CC in the EHR, the resulting information is foundational for future work that can improve the quality of team-based CC; plan staffing, team composition, and labor mapping; determine the cost of CC activities and improve reimbursement in certain settings; and assess outcomes of CC.

This tool has potential for application beyond the PIM team in the VA. The CC Template and training manual is scalable to any setting with team-based CC, including PACT, homeless programs, palliative care, Mental Health Intensive Case Management (MHICM) programs, nurse navigator programs, and other complex care delivery models involving care coordinators. Future study of its implementation and data may inform initiatives to develop ongoing team-based care coordination programs.

Acknowledgments
The authors thank the following colleagues for their input and support: Florence Longchamp, RN, Clinical Applications Coordinator at the Atlanta VA Medical Center without whom the CC Template would not have been created; the Atlanta and San Francisco VA PIM teams for their thoughtful comments and enthusiastic embrace of the CC Template; and the PIM National Evaluation Center for their support of this QI project. PACT Intensive Management demonstration sites are funded by the VA Office of Patient Care Services. During the implementation of the CC Template pilot and the preparation of this paper, the primary author was supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Academic Affiliations, Advanced Fellowships, VA Quality Scholars Program.

Chronic diseases affect a substantial proportion of the US population, with 25% of adults diagnosed with 2 or more chronic health conditions.¹ In 2010, 2 chronic diseases, heart disease and cancer, accounted for nearly 48% of deaths.² Due to the significant public heath burden, strategies to improve chronic disease management have attracted a great deal of focus.^3,4 Within increasingly complex health care delivery systems, policy makers are promoting care coordination (CC) as a tool to reduce fragmented care for patients with multiple comorbidities, improve patient experience and quality of care, and decrease costs and risks for error.^3-8

Background

The Agency for Healthcare Research and Quality (AHRQ) defines care coordination as “deliberately organizing patient care activities and sharing information among all of the participants concerned with a patient’s care to achieve safer and more effective care.”⁵ Nationally, large scale investments have expanded health care models that provide team-based CC, such as patient-centered medical homes, known as patient-aligned care teams (PACTs) within the Department of Veterans Affairs (VA), accountable care organizations, and other complex care management programs.^9-12 Additionally, incentives that reimburse for CC, such as Medicare’s chronic care management and transition care management billing codes, also are emerging.^13,14

While there is significant interest and investment in promoting CC, little data about the specific activities and time required to provide necessary CC exist, which limits the ability of health care teams to optimize CC delivery.⁶ Understanding the components of CC has implications for human resource allocation, labor mapping, reimbursement, staff training, and optimizing collaborative networks for health care systems, which may improve the quality of CC and health outcomes for patients. To date, few tools exist that can be used to identify and track the CC services delivered by interdisciplinary teams within and outside of the health care setting. 

This article describes the development and preliminary results of the implementation of a CC Template that was created in the VA Computerized Patient Record System (CPRS) to identify and track the components of CC services, delivered by a multidisciplinary team, as part of a quality improvement (QI) pilot project. Through use of the template, the team sought a formative understanding of the following questions: (1) Is it feasible to use the CC Template during routine workflow? (2) What specific types of CC services are provided by the team? (3) How much time does it take to perform these activities? (4) Who is the team collaborating with inside and outside of the health care setting and how are they communicating? (5) Given new reimbursement incentives, can the provision of CC be standardized and documented for broad applicability?

In complex systems, where coordination is needed among primary, specialty, hospital, emergency, and nonclinical care settings, a tool such as the CC Template offers a sustainable and replicable way to standardize documentation and knowledge about CC components. This foundational information can be used to optimize team structure, training, and resource allocation, to improve the quality of CC and to link elements of CC with clinical and operational outcomes.

Pact Intensive Management

Despite the implementation of PACT within VA, patients with complex medical conditions combined with socioeconomic stressors, mental health comorbidities, and low health literacy are at high risk for preventable hospitalizations and acute care utilization.^17,18 Due to unmet needs that are beyond what PACTs are able to deliver, these high-risk patients may benefit from additional services to coordinate care within and outside the VA health care system, as suggest by the Extended Chronic Care Model.^19-21

In 2014, the Office of Primary Care Services sponsored a QI initiative at 5 VA demonstration sites to develop PACT Intensive Management (PIM) interventions targeting patients at high risk for hospitalization and acute care utilization within VA. The PIM program design is based on work described previously, with patients identified for enrollment based on 90-day hospitalization risk ≥ 90th percentile, based on a VA risk modeling tool, and an acute care episode in the previous 6 months. ¹⁹ A common component of all PIM programs is the provision of intensive care management and CC by an interdisciplinary team working in conjunction with PACT. The CC Template was developed to assist in documenting and rigorously understanding the implementation of CC by the PIM team.

Local Setting

The Atlanta VA Medical Center (AVAMC) was chosen as one of the PIM demonstration sites. The Atlanta PIM team identified and enrolled a random sample of eligible, high-risk patients from 1 community-based outpatient clinic (CBOC) in an urban location with 7,524 unique patients. Between September 2014 and September 2016, 300 patients were identified, and 86 patients agreed to participate in the PIM program.

In the CC Template pilot, the Atlanta PIM team included 2 nurse practitioners (NP), 2 social workers (SW), and 1 telehealth registered nurse (RN). Upon enrollment, members of the PIM team conducted comprehensive home assessments and offered intensive care management for medical, social, and behavioral needs. The main pillars of care management offered to high-risk patients were based on previous work done both inside and outside VA and included home visits, telephone-based disease management, co-attending appointments with patients, transition care management, and interdisciplinary team meetings with a focus on care coordination between PACT and all services required by patients.^11,19

The Atlanta PIM team performed a variety of tasks to coordinate care for enrolled patients that included simple, 1-step tasks, such as chart reviews, and multistep, complex tasks that required the expertise of multiple team members (Figure 1). 

Additionally, inconsistency in delivery of CC between PIM team members was noted. For example, there was significant variability in CC services provided by different team members in the provision of transition care management (TCM) and coordinating care from hospitalization back to home. Some PIM staff coordinated care and communicated with the patient, hospital team, home-care service, and primary-care team, while other staff only reviewed the chart and placed orders in CPRS. Additionally, much of the CC work was documented in administrative notes that did not trigger workload credit. This made it difficult to show how to appropriately labor map PIM staff or how staff were spending their time caring for patients.

In order to standardize documentation of the interdisciplinary CC activities performed by the PIM team and account for staff time, the Atlanta PIM team decided to develop a CPRS CC Template. The objective of the CC Template was to facilitate documentation of CC activities in the EHR, describe the types of CC activities performed by PIM team members, and track the time to perform these activities for patients with various chronic diseases.

Template Design and Implementation

The original design of the template was informed by the Atlanta PIM team after several informal focus groups and process mapping of CC pathways in the fall of 2015. The participants were all members of the Atlanta PIM team, 2 primary care physicians working with PIM, an AVAMC documentation specialist and a clinical applications coordinator (CAC) assigned to work with PIM. The major themes that arose during the brainstorming discussion were that the template should: (1) be feasible to use during their daily clinic workflow; (2) improve documentation of CC; and (3) have value for spread to other VA sites. Discussion centered on creating a CC Template versatile enough to:

• Decrease the number of steps for documenting CC;
• Consist only of check boxes, with very little need for free text, with the option to enter narrative free text after template completion;
• Document time spent in aggregate for completing complex CC encounters;
• Document various types of CC work and modes of communication;
• Allow for use by all PIM staff;
• Identify all team members that participated in the CC encounter to reduce redundant documentation by multiple staff;
• Adapt to different clinic sites based on the varied disciplines participating in other locations;
• Use evidence-based checklists to help standardize delivery of CC for certain activities such as TCM; and
• Extract data without extensive chart reviews to inform current CC and future QI work.

Following the brainstorming sessions, the authors performed a literature review to identify and integrate CC best practices. The AHRQ Care Coordination Atlas served as the main resource in the design of the logic model that depicted the delivery and subsequent documentation of high-quality, evidence-based CC in the CC Template (Figure 2).⁶ 

After reaching consensus about the key components of the CC Template, the CAC created a pilot version (Figure 3). All of the elements within the CC Template allowed for data abstraction from the VA Corporate Data Warehouse (CDW) via discrete data elements known as health factors. 

Over the course of implementation, the team became more enthusiastic about using the CC template to document previously unrecognized CC workload. Because the CC Template only was used to document CC workload and excluded encounters for clinical evaluation and management, specific notes were created and linked with the CC Template for optimal capture of encounters.

All components of the template were mandatory to eliminate the possibility of missing data. The Atlanta PIM site principal investigator developed a multicomponent training designed to increase support for the template by describing its value and to mitigate the potential for variability in how data are captured. Training included a face-to-face session with the team to review the template and work through sample CC cases. Additionally, a training manual with clear operational definitions and examples of how to complete each element of the CC Template was disseminated. The training was subsequently conducted with the San Francisco VA Medical Center PIM team, a spread site, via video conference. The spread site offered significant feedback on clarifying the training documents and adapting the CC template for their distinct care team structure. This feedback was incorporated into the final CC Template design to increase adaptability.

Implementation Evaluation

The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)framework served as the basis for evaluation of CC Template implementation. The RE-AIM framework is well established and able to evaluate the implementation and potential successful spread of new programs.^23,24 Using RE-AIM, the authors planned to analyze data to explore the reach effectiveness, adoption, implementation, and maintenance of the CC Template use while providing complex care management for high-risk patients.

All data for the evaluation was extracted from the CDW by a data analyst and stored on a secure server. A statistical process control (SPC) chart was used to analyze the implementation process to assess variation in template use.

Results

After implementation, 35 weeks of CC Template pilot data were analyzed from June 1, 2015 to January 5, 2016. The PIM team completed 393 CC Templates over this collection period. After week 23, the CC template was linked to specific CC notes automatically. From weeks 23 to 35 an average of 20.3 CC Templates were completed per week by the team. The RE-AIM was used to assess the implementation of the CC Template.

Reach was determined by the number of patients enrolled in PIM with CC Template documentation. Of patients enrolled in Atlanta PIM, 90.1% had ≥ 1 CC encounter documented by the CC Template; 74.4% of Atlanta PIM patients had ≥ 1 CC encounter documented; 15.5% of patients had > 10 CC encounters documented; and 1 patient had > 25 CC encounters documented by the CC template.

Effectiveness for describing CC activities was captured through data from CC Template. The CC Template documentation by the PIM team showed that 79.4% of CC encounters were < 20 minutes, and 9.9% of encounters were > 61 minutes. Telephone communication was involved in 50.4% of CC encounters, and 24% required multiple modes of communication such as face-to-face, instant messenger, chart-based communication. Care coordination during hospitalization and discharge accounted for 5.9% of template use. Of the CC encounters documenting hospital transitions, 94.4% documented communication with the inpatient team, 58.3% documented coordination with social support, and only 11.1% documented communication with primary care teams. Improving communication with PACT teams after hospital discharge was identified as a future QI project based on these data. The PIM team initiated 83.2% of CC encounters.

Adoption was determined by the use of the CC Template by the team. All 5 team members used the CC template to document at least 1 CC encounter.

Implementation allowed for improvement based on feedback from the PIM team. Mean completion of CC Templates rose from 10.9 per week to 20.3 per week after automatically linking the CC Template to specific CC notes. (Figure 4)

Maintenance was monitored over the course of the pilot. Consistent use of the CC Template over 35 full work weeks of data collection was seen, and mean utilization per week nearly doubled in the latter half of the pilot period.

Because several elements were added to the CC Template over the course of the pilot period, our ability to analyze the data for descriptive statistics about the types of CC services, related diagnoses, collaborators, and PIM staff involved in CC encounters was limited.

Discussion

Though all components of CC encounters could not be assessed during the pilot phase due to continuous improvement of the CC Template, the authors showed that it is feasible to use this tool to document and describe granular details about team-based CC. Pilot data from AVAMC show that the use of the CC Template standardized team CC documentation in a busy clinic setting provided data about the complexity of coordination activities and duration of CC activities. It also informed future CC QI projects, such as improving communication with primary care during the hospital discharge process.

Future evaluation of CC Template data can be used to (1) describe types of CC activities for high-risk PIM patients; (2) quantify the time required to complete CC activities to assist with staff labor mapping; (3) describe staff roles and referrals needed to complete specific CC activities inside and outside VA; (4) describe modes of communication between PIM and collaborators; (5) relate patient demographics and associated diagnoses with quantity of CC encounters; and (6) quantify frequency and time frame of CC after hospitalizations and ED care and subsequent impact on repeat hospitalizations and ED visits. Future research also can explore the link between CC activities and effort with clinical and patient-reported outcomes.

Social network analysis could be used with CC Template data to understand the network of referrals and collaborators involved in the care of a CC team’s patients. This type of analysis would assist teams to strengthen and formalize ties with collaborators as appropriate. For example, if data show that the team frequently collaborates with the cardiology clinic for a large subset of its patients, they may consider creating a CC agreement with formalized modes of communication that would streamline collaboration.

In order to improve the quality of the CC Template and to assess factors that may lead to sustainable use in clinical practice, qualitative assessment through survey, interview, or usability testing with staff would be beneficial to identify strategies to increase its adoption among clinical providers. This type of assessment will add knowledge about the CC Template implementation process, including contextual barriers or facilitators, feasibility of use during day-to-day operations, versatility of template use within construct of team-based care, and overall satisfaction with the template.

Limitations

Though the CC Template offers a large amount of data about the components of CC delivery, the information is based on self-report by staff. Training to ensure that all team members are documenting in the same manner is crucial to maintain the internal validity of the data. The template is limited to the fields currently developed, and future research could explore additional data elements that are critical to include based on feedback from VA staff.

Conclusion

To our knowledge, this VA medical center CC Template is the first tool described in the literature that standardizes and captures data about CC components in the EHR. This pilot data show that the template is feasible for use in a busy clinic setting and can streamline the process for capturing CC data that may otherwise not be documented.

During the pilot phase, the CC template allowed the PIM team to identify a small subset of patients within the PIM complex management who have a high level of CC needs. By identifying these patients, further work can be done to understand the specific needs of these higher utilizers and the types of CC activities required to assist them so that resources can be directed appropriately to that smaller subset. Telephone CC accounted for a large proportion of delivery, which has implications for ensuring that staff have access to mobile phones and EHR capability to document this additional workload. The PIM staff maintained use of the template throughout the pilot period and increased documentation when the CC Template was easily accessible and already linked to their CPRS notes, suggesting that in future implementation, ensuring that the template is linked to notes in use by the care team will be important for successful spread.

Additionally, CC Template data identified gaps in high-quality, evidence-based CC that can be addressed in real time, for example during the discharge process. Data from the CC Template showed that only 11.1% of CC encounters had documentation of communication between the PIM and primary care teams during transitions from hospital to home. Improving communication with PACT teams after hospital discharge was identified as a future PIM QI project based on these data. By improving documentation of CC in the EHR, the resulting information is foundational for future work that can improve the quality of team-based CC; plan staffing, team composition, and labor mapping; determine the cost of CC activities and improve reimbursement in certain settings; and assess outcomes of CC.

This tool has potential for application beyond the PIM team in the VA. The CC Template and training manual is scalable to any setting with team-based CC, including PACT, homeless programs, palliative care, Mental Health Intensive Case Management (MHICM) programs, nurse navigator programs, and other complex care delivery models involving care coordinators. Future study of its implementation and data may inform initiatives to develop ongoing team-based care coordination programs.

Acknowledgments
The authors thank the following colleagues for their input and support: Florence Longchamp, RN, Clinical Applications Coordinator at the Atlanta VA Medical Center without whom the CC Template would not have been created; the Atlanta and San Francisco VA PIM teams for their thoughtful comments and enthusiastic embrace of the CC Template; and the PIM National Evaluation Center for their support of this QI project. PACT Intensive Management demonstration sites are funded by the VA Office of Patient Care Services. During the implementation of the CC Template pilot and the preparation of this paper, the primary author was supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Academic Affiliations, Advanced Fellowships, VA Quality Scholars Program.

Photo by Neil Osterweil

BOSTON—If donors can’t get to the apheresis center, bring the apheresis center to the donors.

Researchers have found that apheresis platelet collection in the field is practical with proper planning and support.

A team at the University of California at Los Angeles (UCLA) Blood and Platelet Center explored adding mobile apheresis units to their existing community blood drives.

They found that, with careful planning and coordination, they could augment their supply of blood products and introduce potential new donors to the idea of apheresis donations at the hospital.

The researchers reported these findings in a poster presentation at AABB 2018 (poster BBC 135).

It all started with a needs drive for an oncology patient at UCLA, explained David Anthony, manager of the UCLA Blood and Platelet Center.

“She wanted to bring in donors and had her whole community behind her,” Anthony said. “And we thought, well, she’s an oncology patient, and she uses platelets, and we had talked about doing platelets out in the field rather than just at fixed sites, and we thought that this would be a good chance to try it.”

Until the mobile unit was established, apheresis platelet collections for the hospital-based donor center were limited to two fixed collection sites, with mobile units used only for collection of whole blood.

To see whether concurrent whole blood and platelet community drives were practical, the center’s blood donor field recruiter requested to schedule a community drive in a region of the county where potential donors had expressed a high level of interest in apheresis platelet donations.

Operations staff visited the site to assess its suitability, including appropriate space for donor registration and history taking, separate areas for whole blood and apheresis donations, and a donor recovery area. The assessment included ensuring there were suitable electrical outlets, space, and support for apheresis machines.

“Over about 2 weeks, we discussed with our medical directors, [infusion technicians], and our mobile people what we would need to do it,” Anthony said. “The recruiter out in the field was able to go to a high school drive out in that area, recruit donors, and get [platelet] precounts from them so that we could find out who was a good candidate.”

Once they had platelet counts from potential apheresis donors, 10 donors were prescreened based on their eligibility to donate multiple products, history of donations and red blood cell loss, and, for women who had previously had more than one pregnancy, favorable human leukocyte antigen test results.

Four of the prescreened donors were scheduled to donate platelets, and the time slot also included two backup donors, one of whom ultimately donated platelets.

The first drive resulted in the collection of seven platelet products, including three double products and one single product.

The donated products resulted in about a $3,000 cost savings by obviating the need for purchasing products from an outside supplier and bolstered the blood bank’s inventory on a normally low collection day, the researchers reported.

“We’ve had two more apheresis drives since then, and we’ll have another one in 3 weeks,” Anthony said.

He acknowledged that it is more challenging to recruit, educate, and retain donors in the field than in the brick-and-mortar hospital setting.

“We have to make sure that they’re going to show up if we’re going to make the effort to take a machine out there, whereas, at our centers, we have regular donors who come in every 2 weeks,” Anthony said. “It’s easy for them to make an appointment, and they know where we are.”

The center plans to continue concurrent monthly whole blood and platelet collection drives, he added.

This pilot program was internally funded. The researchers reported having no relevant conflicts of interest.

Photo by Neil Osterweil

BOSTON—If donors can’t get to the apheresis center, bring the apheresis center to the donors.

Researchers have found that apheresis platelet collection in the field is practical with proper planning and support.

A team at the University of California at Los Angeles (UCLA) Blood and Platelet Center explored adding mobile apheresis units to their existing community blood drives.

They found that, with careful planning and coordination, they could augment their supply of blood products and introduce potential new donors to the idea of apheresis donations at the hospital.

The researchers reported these findings in a poster presentation at AABB 2018 (poster BBC 135).

It all started with a needs drive for an oncology patient at UCLA, explained David Anthony, manager of the UCLA Blood and Platelet Center.

“She wanted to bring in donors and had her whole community behind her,” Anthony said. “And we thought, well, she’s an oncology patient, and she uses platelets, and we had talked about doing platelets out in the field rather than just at fixed sites, and we thought that this would be a good chance to try it.”

Until the mobile unit was established, apheresis platelet collections for the hospital-based donor center were limited to two fixed collection sites, with mobile units used only for collection of whole blood.

To see whether concurrent whole blood and platelet community drives were practical, the center’s blood donor field recruiter requested to schedule a community drive in a region of the county where potential donors had expressed a high level of interest in apheresis platelet donations.

Operations staff visited the site to assess its suitability, including appropriate space for donor registration and history taking, separate areas for whole blood and apheresis donations, and a donor recovery area. The assessment included ensuring there were suitable electrical outlets, space, and support for apheresis machines.

“Over about 2 weeks, we discussed with our medical directors, [infusion technicians], and our mobile people what we would need to do it,” Anthony said. “The recruiter out in the field was able to go to a high school drive out in that area, recruit donors, and get [platelet] precounts from them so that we could find out who was a good candidate.”

Once they had platelet counts from potential apheresis donors, 10 donors were prescreened based on their eligibility to donate multiple products, history of donations and red blood cell loss, and, for women who had previously had more than one pregnancy, favorable human leukocyte antigen test results.

Four of the prescreened donors were scheduled to donate platelets, and the time slot also included two backup donors, one of whom ultimately donated platelets.

The first drive resulted in the collection of seven platelet products, including three double products and one single product.

The donated products resulted in about a $3,000 cost savings by obviating the need for purchasing products from an outside supplier and bolstered the blood bank’s inventory on a normally low collection day, the researchers reported.

“We’ve had two more apheresis drives since then, and we’ll have another one in 3 weeks,” Anthony said.

He acknowledged that it is more challenging to recruit, educate, and retain donors in the field than in the brick-and-mortar hospital setting.

“We have to make sure that they’re going to show up if we’re going to make the effort to take a machine out there, whereas, at our centers, we have regular donors who come in every 2 weeks,” Anthony said. “It’s easy for them to make an appointment, and they know where we are.”

The center plans to continue concurrent monthly whole blood and platelet collection drives, he added.

This pilot program was internally funded. The researchers reported having no relevant conflicts of interest.

Photo by Neil Osterweil

BOSTON—If donors can’t get to the apheresis center, bring the apheresis center to the donors.

Researchers have found that apheresis platelet collection in the field is practical with proper planning and support.

A team at the University of California at Los Angeles (UCLA) Blood and Platelet Center explored adding mobile apheresis units to their existing community blood drives.

They found that, with careful planning and coordination, they could augment their supply of blood products and introduce potential new donors to the idea of apheresis donations at the hospital.

The researchers reported these findings in a poster presentation at AABB 2018 (poster BBC 135).

It all started with a needs drive for an oncology patient at UCLA, explained David Anthony, manager of the UCLA Blood and Platelet Center.

“She wanted to bring in donors and had her whole community behind her,” Anthony said. “And we thought, well, she’s an oncology patient, and she uses platelets, and we had talked about doing platelets out in the field rather than just at fixed sites, and we thought that this would be a good chance to try it.”

Until the mobile unit was established, apheresis platelet collections for the hospital-based donor center were limited to two fixed collection sites, with mobile units used only for collection of whole blood.

To see whether concurrent whole blood and platelet community drives were practical, the center’s blood donor field recruiter requested to schedule a community drive in a region of the county where potential donors had expressed a high level of interest in apheresis platelet donations.

Operations staff visited the site to assess its suitability, including appropriate space for donor registration and history taking, separate areas for whole blood and apheresis donations, and a donor recovery area. The assessment included ensuring there were suitable electrical outlets, space, and support for apheresis machines.

“Over about 2 weeks, we discussed with our medical directors, [infusion technicians], and our mobile people what we would need to do it,” Anthony said. “The recruiter out in the field was able to go to a high school drive out in that area, recruit donors, and get [platelet] precounts from them so that we could find out who was a good candidate.”

Once they had platelet counts from potential apheresis donors, 10 donors were prescreened based on their eligibility to donate multiple products, history of donations and red blood cell loss, and, for women who had previously had more than one pregnancy, favorable human leukocyte antigen test results.

Four of the prescreened donors were scheduled to donate platelets, and the time slot also included two backup donors, one of whom ultimately donated platelets.

The first drive resulted in the collection of seven platelet products, including three double products and one single product.

The donated products resulted in about a $3,000 cost savings by obviating the need for purchasing products from an outside supplier and bolstered the blood bank’s inventory on a normally low collection day, the researchers reported.

“We’ve had two more apheresis drives since then, and we’ll have another one in 3 weeks,” Anthony said.

He acknowledged that it is more challenging to recruit, educate, and retain donors in the field than in the brick-and-mortar hospital setting.

“We have to make sure that they’re going to show up if we’re going to make the effort to take a machine out there, whereas, at our centers, we have regular donors who come in every 2 weeks,” Anthony said. “It’s easy for them to make an appointment, and they know where we are.”

The center plans to continue concurrent monthly whole blood and platelet collection drives, he added.

This pilot program was internally funded. The researchers reported having no relevant conflicts of interest.

Photo by Darren Baker

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on the use of minimal residual disease (MRD) assessment in trials of patients with hematologic malignancies.

The FDA said it developed this guidance to assist sponsors who are planning to use MRD as a biomarker in clinical trials conducted under an investigational new drug application or to support FDA approval of products intended to treat hematologic malignancies.

“As a result of important workshops where we’ve heard from stakeholders and an analysis of marketing applications showing inconsistent quality of MRD data, the FDA identified a need to provide sponsors with guidance on the use of MRD as a biomarker in regulatory submissions,” said FDA Commissioner Scott Gottlieb, MD.

The guidance explains how MRD might be used in clinical trials, highlights considerations for MRD assessment that are specific to certain hematologic malignancies, and lists requirements for regulatory submissions that utilize MRD.

The full document, “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment,” is available for download from the FDA website.

How MRD can be used

The guidance notes that MRD could potentially be used as a biomarker in clinical trials, specifically, as a diagnostic, prognostic, predictive, efficacy-response, or monitoring biomarker.

MRD could also be used as a surrogate endpoint, and there are two mechanisms for obtaining FDA feedback on the use of a novel surrogate endpoint to support approval of a product:

1. The drug development tool qualification process
2. Discussions with the specific Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research review division.

Furthermore, a sponsor can use MRD “to select patients at high risk or to enrich the trial population,” according to the guidance.

Disease specifics

The guidance also details specific considerations for MRD assessment in individual hematologic malignancies. For example:

• In acute lymphoblastic leukemia, a patient with an MRD level of 0.1% or more in first or second complete remission has a high risk of relapse.
• In trials of acute myeloid leukemia, the sponsor should provide data showing that the marker selected to assess MRD “reflects the leukemia and not underlying clonal hematopoiesis.”
• Patients with low-risk acute promyelocytic leukemia who achieve MRD negativity after arsenic/tretinoin-based therapy are generally considered cured.
• In chronic lymphocytic leukemia, MRD can be assessed in the peripheral blood or bone marrow, but the sample source should remain the same throughout a trial.
• In chronic myeloid leukemia, MRD can be used to select and monitor patients who are eligible to discontinue treatment with tyrosine kinase inhibitors.
• In multiple myeloma, imaging techniques may be combined with MRD assessment of the bone marrow to assess patient response to treatment.

Types of technology

The guidance lists the four general technologies used for MRD assessment in hematologic malignancies:

• Multiparametric flow cytometry
• Next-generation sequencing
• Quantitative reverse transcription polymerase chain reaction of specific gene fusions
• Allele-specific oligonucleotide polymerase chain reaction.

The FDA said it does not have a preference as to which technology is used in a trial. However, the sponsor must pre-specify the technology used and should utilize the same technology throughout a trial.

The FDA also said it “does not foresee the need for co-development of an MRD assay with a drug product.” However, the assay must be analytically valid for results important to the trial, and MRD assessment must be a clinically valid biomarker in the context in which it’s used.

If the MRD assay used is not FDA-cleared or -approved, additional information about the assay must be provided to the FDA.

Photo by Darren Baker

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on the use of minimal residual disease (MRD) assessment in trials of patients with hematologic malignancies.

The FDA said it developed this guidance to assist sponsors who are planning to use MRD as a biomarker in clinical trials conducted under an investigational new drug application or to support FDA approval of products intended to treat hematologic malignancies.

“As a result of important workshops where we’ve heard from stakeholders and an analysis of marketing applications showing inconsistent quality of MRD data, the FDA identified a need to provide sponsors with guidance on the use of MRD as a biomarker in regulatory submissions,” said FDA Commissioner Scott Gottlieb, MD.

The guidance explains how MRD might be used in clinical trials, highlights considerations for MRD assessment that are specific to certain hematologic malignancies, and lists requirements for regulatory submissions that utilize MRD.

The full document, “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment,” is available for download from the FDA website.

How MRD can be used

The guidance notes that MRD could potentially be used as a biomarker in clinical trials, specifically, as a diagnostic, prognostic, predictive, efficacy-response, or monitoring biomarker.

MRD could also be used as a surrogate endpoint, and there are two mechanisms for obtaining FDA feedback on the use of a novel surrogate endpoint to support approval of a product:

1. The drug development tool qualification process
2. Discussions with the specific Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research review division.

Furthermore, a sponsor can use MRD “to select patients at high risk or to enrich the trial population,” according to the guidance.

Disease specifics

The guidance also details specific considerations for MRD assessment in individual hematologic malignancies. For example:

• In acute lymphoblastic leukemia, a patient with an MRD level of 0.1% or more in first or second complete remission has a high risk of relapse.
• In trials of acute myeloid leukemia, the sponsor should provide data showing that the marker selected to assess MRD “reflects the leukemia and not underlying clonal hematopoiesis.”
• Patients with low-risk acute promyelocytic leukemia who achieve MRD negativity after arsenic/tretinoin-based therapy are generally considered cured.
• In chronic lymphocytic leukemia, MRD can be assessed in the peripheral blood or bone marrow, but the sample source should remain the same throughout a trial.
• In chronic myeloid leukemia, MRD can be used to select and monitor patients who are eligible to discontinue treatment with tyrosine kinase inhibitors.
• In multiple myeloma, imaging techniques may be combined with MRD assessment of the bone marrow to assess patient response to treatment.

Types of technology

The guidance lists the four general technologies used for MRD assessment in hematologic malignancies:

• Multiparametric flow cytometry
• Next-generation sequencing
• Quantitative reverse transcription polymerase chain reaction of specific gene fusions
• Allele-specific oligonucleotide polymerase chain reaction.

The FDA said it does not have a preference as to which technology is used in a trial. However, the sponsor must pre-specify the technology used and should utilize the same technology throughout a trial.

The FDA also said it “does not foresee the need for co-development of an MRD assay with a drug product.” However, the assay must be analytically valid for results important to the trial, and MRD assessment must be a clinically valid biomarker in the context in which it’s used.

If the MRD assay used is not FDA-cleared or -approved, additional information about the assay must be provided to the FDA.

Photo by Darren Baker

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on the use of minimal residual disease (MRD) assessment in trials of patients with hematologic malignancies.

The FDA said it developed this guidance to assist sponsors who are planning to use MRD as a biomarker in clinical trials conducted under an investigational new drug application or to support FDA approval of products intended to treat hematologic malignancies.

“As a result of important workshops where we’ve heard from stakeholders and an analysis of marketing applications showing inconsistent quality of MRD data, the FDA identified a need to provide sponsors with guidance on the use of MRD as a biomarker in regulatory submissions,” said FDA Commissioner Scott Gottlieb, MD.

The guidance explains how MRD might be used in clinical trials, highlights considerations for MRD assessment that are specific to certain hematologic malignancies, and lists requirements for regulatory submissions that utilize MRD.

The full document, “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment,” is available for download from the FDA website.

How MRD can be used

The guidance notes that MRD could potentially be used as a biomarker in clinical trials, specifically, as a diagnostic, prognostic, predictive, efficacy-response, or monitoring biomarker.

MRD could also be used as a surrogate endpoint, and there are two mechanisms for obtaining FDA feedback on the use of a novel surrogate endpoint to support approval of a product:

1. The drug development tool qualification process
2. Discussions with the specific Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research review division.

Furthermore, a sponsor can use MRD “to select patients at high risk or to enrich the trial population,” according to the guidance.

Disease specifics

The guidance also details specific considerations for MRD assessment in individual hematologic malignancies. For example:

• In acute lymphoblastic leukemia, a patient with an MRD level of 0.1% or more in first or second complete remission has a high risk of relapse.
• In trials of acute myeloid leukemia, the sponsor should provide data showing that the marker selected to assess MRD “reflects the leukemia and not underlying clonal hematopoiesis.”
• Patients with low-risk acute promyelocytic leukemia who achieve MRD negativity after arsenic/tretinoin-based therapy are generally considered cured.
• In chronic lymphocytic leukemia, MRD can be assessed in the peripheral blood or bone marrow, but the sample source should remain the same throughout a trial.
• In chronic myeloid leukemia, MRD can be used to select and monitor patients who are eligible to discontinue treatment with tyrosine kinase inhibitors.
• In multiple myeloma, imaging techniques may be combined with MRD assessment of the bone marrow to assess patient response to treatment.

Types of technology

The guidance lists the four general technologies used for MRD assessment in hematologic malignancies:

• Multiparametric flow cytometry
• Next-generation sequencing
• Quantitative reverse transcription polymerase chain reaction of specific gene fusions
• Allele-specific oligonucleotide polymerase chain reaction.

The FDA said it does not have a preference as to which technology is used in a trial. However, the sponsor must pre-specify the technology used and should utilize the same technology throughout a trial.

The FDA also said it “does not foresee the need for co-development of an MRD assay with a drug product.” However, the assay must be analytically valid for results important to the trial, and MRD assessment must be a clinically valid biomarker in the context in which it’s used.

If the MRD assay used is not FDA-cleared or -approved, additional information about the assay must be provided to the FDA.

Toni Valković, MD, PhD

DUBROVNIK, CROATIA—Clinical trials are needed to answer the many questions related to minimal residual disease (MRD) assessment in multiple myeloma (MM), according to a speaker at Leukemia and Lymphoma: Europe and the USA, Linking Knowledge and Practice.

MM patients are increasingly assessed for MRD, which is a strong prognostic factor and surrogate for overall survival, according to Toni Valković, MD, PhD, of University Hospital Center Rijeka in Croatia.

However, Dr. Valković said MRD assessment has not become a part of routine clinical practice, perhaps because we haven’t determined the best way to utilize MRD assessment in MM patients.

The optimal sensitivity threshold, technique, and timing of MRD assessment are not known, and it isn’t clear how MRD should be used to guide treatment.

What we know

Dr. Valković cited studies showing that MRD negativity is associated with superior survival in MM¹, and, when MRD negativity is achieved, high-risk cytogenetics, age, and previous treatment regimens appear to have no further impact on prognosis.²

Dr. Valković went on to explain the benefits and detriments of multiparametric flow cytometry (MFC) and next-generation sequencing (NGS) for MRD assessment.³

NGS requires a baseline patient sample, but MFC does not. More cells are required with MFC than with NGS (>5 million vs. <1 million).

With MFC, samples must be processed within 24 to 48 hours, whereas, with NGS, fresh or stored samples can be used. MFC can be done in a few hours, while NGS can take several days.

Despite these differences, both methods provide similar levels of sensitivity for detecting MRD (≥1 in 10⁵).

Dr. Valković also noted that MRD should be evaluated outside the bone marrow as well, which can be done with positron emission tomography-computed tomography (PET-CT).

Research has shown that patients who are MRD-negative according to both MFC and PET-CT have better outcomes than patients who are MRD-positive by MFC, PET-CT, or both.⁴

What we don’t know

Though he compared MFC and NGS, Dr. Valković said we don’t know the optimal technique for assessing MRD in the bone marrow.

Another uncertainty is the optimal sensitivity threshold. In the POLLUX study⁵, researchers found that a threshold of 10^-4 resulted in lots of patients with MRD negativity, but some of these were false-negatives.

So although 10^-4 proved inaccurate, it isn’t clear if the optimal threshold is 10^-5 or 10^-6, Dr. Valković said.

Likewise, it isn’t clear if PET-CT is the optimal method for evaluating MRD outside the bone marrow.

In a study published in 2017, PET produced false-negatives in MM patients.⁶ In 11% of patients (26/227), there was evidence of disease with diffusion-weighted magnetic resonance imaging with background signal suppression, but there was no apparent disease with PET. The researchers said low expression of hexokinase-2 was associated with a false-negative PET result.

Finally, Dr. Valković said we don’t know how best to use MRD to tailor therapy in MM patients. He posed the following questions:

• If patients don’t achieve MRD negativity, should they continue on the therapy?
• If MRD-negative patients become MRD-positive, should they begin therapy immediately, or should treatment be put off until a biochemical or clinical relapse?
• Should MRD status be used to determine the number of treatment cycles a patient receives, the timing of transplant, or when to begin and end maintenance therapy?

“There are a lot of issues and unanswered questions related to the optimal techniques for the evaluation of MRD and their sensitivity, the timing for MRD assessment during and after therapy, and its role in the treatment decisions, which should be answered in future clinical studies,” Dr. Valković concluded.

He did not declare any conflicts of interest.

1. Munshi NC et al. JAMA Oncol. 2017;3(1):28-35. doi:10.1001/jamaoncol.2016.3160

2. Paiva B et al. Blood. 2016 Jun 23;127(25):3165-74. doi: 10.1182/blood-2016-03-705319

3. Kumar S et al. Lancet Oncol. 2016; 17 (8):e328-46 doi: https://doi.org/10.1016/S1470-2045(16)30206-6

4. Fernandez RA et al. Blood. 2017; 130:3098

5. Dimopoulos MA et al. Haematologica. 2018 Sep 20. pii: haematol.2018.194282. doi: 10.3324/haematol.2018.194282

6. Rasche L et al. Blood. 2017 Jul 6;130(1):30-34. doi: 10.1182/blood-2017-03-774422

Toni Valković, MD, PhD

DUBROVNIK, CROATIA—Clinical trials are needed to answer the many questions related to minimal residual disease (MRD) assessment in multiple myeloma (MM), according to a speaker at Leukemia and Lymphoma: Europe and the USA, Linking Knowledge and Practice.

MM patients are increasingly assessed for MRD, which is a strong prognostic factor and surrogate for overall survival, according to Toni Valković, MD, PhD, of University Hospital Center Rijeka in Croatia.

However, Dr. Valković said MRD assessment has not become a part of routine clinical practice, perhaps because we haven’t determined the best way to utilize MRD assessment in MM patients.

The optimal sensitivity threshold, technique, and timing of MRD assessment are not known, and it isn’t clear how MRD should be used to guide treatment.

What we know

Dr. Valković cited studies showing that MRD negativity is associated with superior survival in MM¹, and, when MRD negativity is achieved, high-risk cytogenetics, age, and previous treatment regimens appear to have no further impact on prognosis.²

Dr. Valković went on to explain the benefits and detriments of multiparametric flow cytometry (MFC) and next-generation sequencing (NGS) for MRD assessment.³

NGS requires a baseline patient sample, but MFC does not. More cells are required with MFC than with NGS (>5 million vs. <1 million).

With MFC, samples must be processed within 24 to 48 hours, whereas, with NGS, fresh or stored samples can be used. MFC can be done in a few hours, while NGS can take several days.

Despite these differences, both methods provide similar levels of sensitivity for detecting MRD (≥1 in 10⁵).

Dr. Valković also noted that MRD should be evaluated outside the bone marrow as well, which can be done with positron emission tomography-computed tomography (PET-CT).

Research has shown that patients who are MRD-negative according to both MFC and PET-CT have better outcomes than patients who are MRD-positive by MFC, PET-CT, or both.⁴

What we don’t know

Though he compared MFC and NGS, Dr. Valković said we don’t know the optimal technique for assessing MRD in the bone marrow.

Another uncertainty is the optimal sensitivity threshold. In the POLLUX study⁵, researchers found that a threshold of 10^-4 resulted in lots of patients with MRD negativity, but some of these were false-negatives.

So although 10^-4 proved inaccurate, it isn’t clear if the optimal threshold is 10^-5 or 10^-6, Dr. Valković said.

Likewise, it isn’t clear if PET-CT is the optimal method for evaluating MRD outside the bone marrow.

In a study published in 2017, PET produced false-negatives in MM patients.⁶ In 11% of patients (26/227), there was evidence of disease with diffusion-weighted magnetic resonance imaging with background signal suppression, but there was no apparent disease with PET. The researchers said low expression of hexokinase-2 was associated with a false-negative PET result.

Finally, Dr. Valković said we don’t know how best to use MRD to tailor therapy in MM patients. He posed the following questions:

• If patients don’t achieve MRD negativity, should they continue on the therapy?
• If MRD-negative patients become MRD-positive, should they begin therapy immediately, or should treatment be put off until a biochemical or clinical relapse?
• Should MRD status be used to determine the number of treatment cycles a patient receives, the timing of transplant, or when to begin and end maintenance therapy?

“There are a lot of issues and unanswered questions related to the optimal techniques for the evaluation of MRD and their sensitivity, the timing for MRD assessment during and after therapy, and its role in the treatment decisions, which should be answered in future clinical studies,” Dr. Valković concluded.

He did not declare any conflicts of interest.

1. Munshi NC et al. JAMA Oncol. 2017;3(1):28-35. doi:10.1001/jamaoncol.2016.3160

2. Paiva B et al. Blood. 2016 Jun 23;127(25):3165-74. doi: 10.1182/blood-2016-03-705319

3. Kumar S et al. Lancet Oncol. 2016; 17 (8):e328-46 doi: https://doi.org/10.1016/S1470-2045(16)30206-6

4. Fernandez RA et al. Blood. 2017; 130:3098

5. Dimopoulos MA et al. Haematologica. 2018 Sep 20. pii: haematol.2018.194282. doi: 10.3324/haematol.2018.194282

6. Rasche L et al. Blood. 2017 Jul 6;130(1):30-34. doi: 10.1182/blood-2017-03-774422

Toni Valković, MD, PhD

DUBROVNIK, CROATIA—Clinical trials are needed to answer the many questions related to minimal residual disease (MRD) assessment in multiple myeloma (MM), according to a speaker at Leukemia and Lymphoma: Europe and the USA, Linking Knowledge and Practice.

MM patients are increasingly assessed for MRD, which is a strong prognostic factor and surrogate for overall survival, according to Toni Valković, MD, PhD, of University Hospital Center Rijeka in Croatia.

However, Dr. Valković said MRD assessment has not become a part of routine clinical practice, perhaps because we haven’t determined the best way to utilize MRD assessment in MM patients.

The optimal sensitivity threshold, technique, and timing of MRD assessment are not known, and it isn’t clear how MRD should be used to guide treatment.

What we know

Dr. Valković cited studies showing that MRD negativity is associated with superior survival in MM¹, and, when MRD negativity is achieved, high-risk cytogenetics, age, and previous treatment regimens appear to have no further impact on prognosis.²

Dr. Valković went on to explain the benefits and detriments of multiparametric flow cytometry (MFC) and next-generation sequencing (NGS) for MRD assessment.³

NGS requires a baseline patient sample, but MFC does not. More cells are required with MFC than with NGS (>5 million vs. <1 million).

With MFC, samples must be processed within 24 to 48 hours, whereas, with NGS, fresh or stored samples can be used. MFC can be done in a few hours, while NGS can take several days.

Despite these differences, both methods provide similar levels of sensitivity for detecting MRD (≥1 in 10⁵).

Dr. Valković also noted that MRD should be evaluated outside the bone marrow as well, which can be done with positron emission tomography-computed tomography (PET-CT).

Research has shown that patients who are MRD-negative according to both MFC and PET-CT have better outcomes than patients who are MRD-positive by MFC, PET-CT, or both.⁴

What we don’t know

Though he compared MFC and NGS, Dr. Valković said we don’t know the optimal technique for assessing MRD in the bone marrow.

Another uncertainty is the optimal sensitivity threshold. In the POLLUX study⁵, researchers found that a threshold of 10^-4 resulted in lots of patients with MRD negativity, but some of these were false-negatives.

So although 10^-4 proved inaccurate, it isn’t clear if the optimal threshold is 10^-5 or 10^-6, Dr. Valković said.

Likewise, it isn’t clear if PET-CT is the optimal method for evaluating MRD outside the bone marrow.

In a study published in 2017, PET produced false-negatives in MM patients.⁶ In 11% of patients (26/227), there was evidence of disease with diffusion-weighted magnetic resonance imaging with background signal suppression, but there was no apparent disease with PET. The researchers said low expression of hexokinase-2 was associated with a false-negative PET result.

Finally, Dr. Valković said we don’t know how best to use MRD to tailor therapy in MM patients. He posed the following questions:

• If patients don’t achieve MRD negativity, should they continue on the therapy?
• If MRD-negative patients become MRD-positive, should they begin therapy immediately, or should treatment be put off until a biochemical or clinical relapse?
• Should MRD status be used to determine the number of treatment cycles a patient receives, the timing of transplant, or when to begin and end maintenance therapy?

“There are a lot of issues and unanswered questions related to the optimal techniques for the evaluation of MRD and their sensitivity, the timing for MRD assessment during and after therapy, and its role in the treatment decisions, which should be answered in future clinical studies,” Dr. Valković concluded.

He did not declare any conflicts of interest.

1. Munshi NC et al. JAMA Oncol. 2017;3(1):28-35. doi:10.1001/jamaoncol.2016.3160

2. Paiva B et al. Blood. 2016 Jun 23;127(25):3165-74. doi: 10.1182/blood-2016-03-705319

3. Kumar S et al. Lancet Oncol. 2016; 17 (8):e328-46 doi: https://doi.org/10.1016/S1470-2045(16)30206-6

4. Fernandez RA et al. Blood. 2017; 130:3098

5. Dimopoulos MA et al. Haematologica. 2018 Sep 20. pii: haematol.2018.194282. doi: 10.3324/haematol.2018.194282

6. Rasche L et al. Blood. 2017 Jul 6;130(1):30-34. doi: 10.1182/blood-2017-03-774422

College of Georgia

SAN ANTONIO—The recommended approach to evaluating suspected pulmonary embolism (PE) is “greatly underutilized” in the Veterans Health Administration system, according to a speaker at CHEST 2018.

A survey showed that, contrary to guideline recommendations, most Veterans Affairs sites did not require incorporation of a clinical decision rule (CDR) and D-dimer prior to the ordering of computed tomographic pulmonary angiography (CTPA) for suspected PE.

Therefore, CTPA was overused.

Nancy Hsu, MD, a pulmonologist in Los Angeles, California, discussed this finding at the meeting.

She noted that CTPA has become the imaging modality of choice for evaluating suspected PE, but it is overused and potentially avoidable in one-third of cases.

“In the 10 years following the advent of CTPA use, there was a 14-fold increase in usage, but there was no change in mortality,” Dr. Hsu said. “This is consistent with overdiagnosis.”

Indiscriminate use of CTPA results in unnecessary and avoidable radiation exposure, contrast-related reactions, and treatment-related bleeding, Dr. Hsu noted.

She and a colleague discovered CTPA overuse in the Veterans Health Administration system by conducting a survey of stakeholders at 18 Veterans Integrated Service Networks and 143 medical centers.

A total of 120 fully completed questionnaires were analyzed. Most respondents (63%) were chief physicians, and 80% had 11 or more years of experience.

Most respondents (85%) said CDR with or without D-dimer was not required before ordering CTPA. Less than 7% of respondents said they required both CDR and D-dimer before CTPA.

The biggest barrier to optimal practice may be the fear of having a patient who “falls through the cracks” based on false-negative CDR and D-dimer data, according to Dr. Hsu.

On the other hand, judicious use of CTPA likely avoids negative sequelae related to radiation, contrast exposure, and treatment-related bleeding, she said.

Dr. Hsu and her colleague, Guy Soo Hoo, MD, said they had no relationships relevant to this research.

College of Georgia

SAN ANTONIO—The recommended approach to evaluating suspected pulmonary embolism (PE) is “greatly underutilized” in the Veterans Health Administration system, according to a speaker at CHEST 2018.

A survey showed that, contrary to guideline recommendations, most Veterans Affairs sites did not require incorporation of a clinical decision rule (CDR) and D-dimer prior to the ordering of computed tomographic pulmonary angiography (CTPA) for suspected PE.

Therefore, CTPA was overused.

Nancy Hsu, MD, a pulmonologist in Los Angeles, California, discussed this finding at the meeting.

She noted that CTPA has become the imaging modality of choice for evaluating suspected PE, but it is overused and potentially avoidable in one-third of cases.

“In the 10 years following the advent of CTPA use, there was a 14-fold increase in usage, but there was no change in mortality,” Dr. Hsu said. “This is consistent with overdiagnosis.”

Indiscriminate use of CTPA results in unnecessary and avoidable radiation exposure, contrast-related reactions, and treatment-related bleeding, Dr. Hsu noted.

She and a colleague discovered CTPA overuse in the Veterans Health Administration system by conducting a survey of stakeholders at 18 Veterans Integrated Service Networks and 143 medical centers.

A total of 120 fully completed questionnaires were analyzed. Most respondents (63%) were chief physicians, and 80% had 11 or more years of experience.

Most respondents (85%) said CDR with or without D-dimer was not required before ordering CTPA. Less than 7% of respondents said they required both CDR and D-dimer before CTPA.

The biggest barrier to optimal practice may be the fear of having a patient who “falls through the cracks” based on false-negative CDR and D-dimer data, according to Dr. Hsu.

On the other hand, judicious use of CTPA likely avoids negative sequelae related to radiation, contrast exposure, and treatment-related bleeding, she said.

Dr. Hsu and her colleague, Guy Soo Hoo, MD, said they had no relationships relevant to this research.

College of Georgia

SAN ANTONIO—The recommended approach to evaluating suspected pulmonary embolism (PE) is “greatly underutilized” in the Veterans Health Administration system, according to a speaker at CHEST 2018.

A survey showed that, contrary to guideline recommendations, most Veterans Affairs sites did not require incorporation of a clinical decision rule (CDR) and D-dimer prior to the ordering of computed tomographic pulmonary angiography (CTPA) for suspected PE.

Therefore, CTPA was overused.

Nancy Hsu, MD, a pulmonologist in Los Angeles, California, discussed this finding at the meeting.

She noted that CTPA has become the imaging modality of choice for evaluating suspected PE, but it is overused and potentially avoidable in one-third of cases.

“In the 10 years following the advent of CTPA use, there was a 14-fold increase in usage, but there was no change in mortality,” Dr. Hsu said. “This is consistent with overdiagnosis.”

Indiscriminate use of CTPA results in unnecessary and avoidable radiation exposure, contrast-related reactions, and treatment-related bleeding, Dr. Hsu noted.

She and a colleague discovered CTPA overuse in the Veterans Health Administration system by conducting a survey of stakeholders at 18 Veterans Integrated Service Networks and 143 medical centers.

A total of 120 fully completed questionnaires were analyzed. Most respondents (63%) were chief physicians, and 80% had 11 or more years of experience.

Most respondents (85%) said CDR with or without D-dimer was not required before ordering CTPA. Less than 7% of respondents said they required both CDR and D-dimer before CTPA.

The biggest barrier to optimal practice may be the fear of having a patient who “falls through the cracks” based on false-negative CDR and D-dimer data, according to Dr. Hsu.

On the other hand, judicious use of CTPA likely avoids negative sequelae related to radiation, contrast exposure, and treatment-related bleeding, she said.

Dr. Hsu and her colleague, Guy Soo Hoo, MD, said they had no relationships relevant to this research.

IN THIS ARTICLE

• Prostate cancer screening tools
• Ethic disparities
• Screening guidance

Prostate cancer, the second most common cancer to affect American men, is a slow-growing cancer that is curable when detected early. While the overall incidence has declined in the past 20 years (see Figure 1), prostate cancer remains a major concern among black men due to disproportionate incidence and mortality rates.^1-3 A general understanding of the prostate and of prostate cancer lays the groundwork to acknowledge and address this divide.

ANATOMY OF THE PROSTATE

Although most men know where the prostate gland is located, many do not understand how it functions.⁴ The largest accessory gland of the male reproductive system, the prostate is located below the bladder and in front of the rectum (see Figure 2).⁵ The urethra passes through this gland; therefore, enlargement of the prostate can cause constriction of the urethra, which can affect the ability to eliminate urine from the body.⁵

The prostate is broken down into four distinct regions (see Figure 3). Certain types of inflammation may occur more often in some regions of the prostate than others; as such, 75% of prostate cancer occurs in the peripheral zone (the region located closest to the rectal wall).^5,6

DIAGNOSING PROSTATE CANCER

Signs and symptoms

According to the CDC, the signs and symptoms of prostate cancer include

• Difficulty starting urination
• Weak or interrupted flow of urine
• Frequent urination (especially at night)
• Difficulty emptying the bladder
• Pain or burning during urination
• Blood in the urine or semen
• Pain in the back, hips, or pelvis
• Painful ejaculation.

However, none of these signs and symptoms are unique to prostate cancer.⁷ For instance, difficulty starting urination, weak or interrupted flow of urine, and frequent urination can also be attributed to benign prostatic hyperplasia. Further, in its early stages, prostate cancer may not exhibit any signs or symptoms, making accurate screening essential for detection and treatment.⁷

Screening tools

There are two primary tools for detection of prostate cancer: the prostate-specific antigen (PSA) test and the digital rectal exam (DRE).⁸ The blood test for PSA is routinely used as a screening tool and is therefore considered a standard test for prostate cancer.⁹ A PSA level above 4.0 ng/mL is considered abnormal.¹⁰ Although measuring the PSA level can improve the odds of early prostate cancer detection, there is considerable debate over its dependability in this regard, as PSA can be elevated for benign reasons.

Sociocultural and genetic risk factors

While both black and white men are at an increased risk for prostate cancer if a first-degree relative (ie, father, brother, son) had the disease, one in five black men will develop prostate cancer in their lifetimes, compared with one in seven white men.³ And despite a five-year survival rate of nearly 100% for regional prostate cancer, black men are more than two times as likely as white men to die of the disease (1 in 23 and 1 in 38, respectively).^8,11 From 2011 to 2015, the age-adjusted mortality rate of prostate cancer among black men was 40.8, versus 18.2 for non-Hispanic white men (per 100,000 population).¹²

Continue to: The disparity in prostate cancer mortality...

The disparity in prostate cancer mortality among black men has been attributed to multiple variables. Cultural differences can play a role in whether patients choose to undergo prostate cancer screening. Black men are, for example, less likely than other men to participate in preventive health care practices.¹³ Although an in-depth discussion is outside the scope of this article, researchers have identified some plausible factors for this, including economic limitations, lack of access to health care, distrust of the health care system, and an indifference to pain or discomfort.^13,14 Decisions surrounding prostate screening can also be affected by a patient’s perceived risk for prostate cancer, the impact of a cancer diagnosis, and the availability of treatment.

Other factors that contribute to the higher incidence and mortality rate among black men include genetic predisposition, health beliefs, and knowledge about the prostate and cancer screenings.¹⁵ While most researchers have focused on men ages 40 and older, Ogunsanya et al suggested that educating black men about screening for prostate cancer at an earlier age may help them to make informed decisions later in life.¹⁵

PRACTICE POINTS

• Prostate cancer remains a major concern among black men due to disproportionate incidence and mortality.
• Developing prostate cancer screening recommendations for black men would help reduce mortality and morbidity in this population.
• Educating black men about screening for prostate cancer at an earlier age may help them to make informed decisions later in life.

IMPLICATIONS FOR PRACTICE

The age at which men should begin screening for prostate cancer has been a source of controversy due to the lack of consensus between the American Cancer Society, the American Urological Association, and the United States Preventive Services Task Force (USPSTF) guidelines (see Table).^16-18 The current USPSTF recommendations for prostate cancer screening do not take into account ethnic differences, despite the identified racial disparity.¹⁹ Ambiguity in public health policy creates a quandary in the decision-making process regarding testing and treatment.^9,19,20

Early screening and intervention is necessary to help mitigate prostate cancer morbidity and mortality.²¹The authors support the use of the American Cancer Society guidelines, which are comprehensive and clearly define who is considered to be at risk. The guidelines suggest screening black men and men with known family histories (considered to be at high risk) at age 45, and screening men with a strong family history (multiple first-degree relatives who developed prostate cancer at a young age) beginning at age 40.

In addition, these guidelines recommend the use of both the DRE and PSA screening tests. Screening should be performed every two years for men who have a PSA level < 2.5 ng/mL, and every year for men who have a level > 2.5 ng/mL.

Continue to: TREATMENT

Fortunately, there are several treatment options for men who are diagnosed with prostate cancer.²² These include watchful waiting, surgery, radiation, cryotherapy, hormone therapy, and chemotherapy. The type of treatment chosen depends on many factors, such as the tumor grade or cancer stage, the implications for quality of life, and the shared provider/patient decision-making process. Indeed, choosing the right treatment is a specialized approach that varies according to case and circumstance.²²

CONCLUSION

There has been an increase in prostate cancer screening in recent years. However, black men still lag behind when it comes to having DRE and PSA tests. Many factors, including cultural perceptions of medical care among black men, often cause delays in seeking evaluation and treatment. Developing consistent and uniform prostate cancer screening recommendations for black men would be an important step in reducing mortality and morbidity in this population.

IN THIS ARTICLE

• Prostate cancer screening tools
• Ethic disparities
• Screening guidance

Prostate cancer, the second most common cancer to affect American men, is a slow-growing cancer that is curable when detected early. While the overall incidence has declined in the past 20 years (see Figure 1), prostate cancer remains a major concern among black men due to disproportionate incidence and mortality rates.^1-3 A general understanding of the prostate and of prostate cancer lays the groundwork to acknowledge and address this divide.

ANATOMY OF THE PROSTATE

Although most men know where the prostate gland is located, many do not understand how it functions.⁴ The largest accessory gland of the male reproductive system, the prostate is located below the bladder and in front of the rectum (see Figure 2).⁵ The urethra passes through this gland; therefore, enlargement of the prostate can cause constriction of the urethra, which can affect the ability to eliminate urine from the body.⁵

The prostate is broken down into four distinct regions (see Figure 3). Certain types of inflammation may occur more often in some regions of the prostate than others; as such, 75% of prostate cancer occurs in the peripheral zone (the region located closest to the rectal wall).^5,6

DIAGNOSING PROSTATE CANCER

Signs and symptoms

According to the CDC, the signs and symptoms of prostate cancer include

• Difficulty starting urination
• Weak or interrupted flow of urine
• Frequent urination (especially at night)
• Difficulty emptying the bladder
• Pain or burning during urination
• Blood in the urine or semen
• Pain in the back, hips, or pelvis
• Painful ejaculation.

However, none of these signs and symptoms are unique to prostate cancer.⁷ For instance, difficulty starting urination, weak or interrupted flow of urine, and frequent urination can also be attributed to benign prostatic hyperplasia. Further, in its early stages, prostate cancer may not exhibit any signs or symptoms, making accurate screening essential for detection and treatment.⁷

Screening tools

There are two primary tools for detection of prostate cancer: the prostate-specific antigen (PSA) test and the digital rectal exam (DRE).⁸ The blood test for PSA is routinely used as a screening tool and is therefore considered a standard test for prostate cancer.⁹ A PSA level above 4.0 ng/mL is considered abnormal.¹⁰ Although measuring the PSA level can improve the odds of early prostate cancer detection, there is considerable debate over its dependability in this regard, as PSA can be elevated for benign reasons.

Sociocultural and genetic risk factors

While both black and white men are at an increased risk for prostate cancer if a first-degree relative (ie, father, brother, son) had the disease, one in five black men will develop prostate cancer in their lifetimes, compared with one in seven white men.³ And despite a five-year survival rate of nearly 100% for regional prostate cancer, black men are more than two times as likely as white men to die of the disease (1 in 23 and 1 in 38, respectively).^8,11 From 2011 to 2015, the age-adjusted mortality rate of prostate cancer among black men was 40.8, versus 18.2 for non-Hispanic white men (per 100,000 population).¹²

Continue to: The disparity in prostate cancer mortality...

The disparity in prostate cancer mortality among black men has been attributed to multiple variables. Cultural differences can play a role in whether patients choose to undergo prostate cancer screening. Black men are, for example, less likely than other men to participate in preventive health care practices.¹³ Although an in-depth discussion is outside the scope of this article, researchers have identified some plausible factors for this, including economic limitations, lack of access to health care, distrust of the health care system, and an indifference to pain or discomfort.^13,14 Decisions surrounding prostate screening can also be affected by a patient’s perceived risk for prostate cancer, the impact of a cancer diagnosis, and the availability of treatment.

Other factors that contribute to the higher incidence and mortality rate among black men include genetic predisposition, health beliefs, and knowledge about the prostate and cancer screenings.¹⁵ While most researchers have focused on men ages 40 and older, Ogunsanya et al suggested that educating black men about screening for prostate cancer at an earlier age may help them to make informed decisions later in life.¹⁵

PRACTICE POINTS

• Prostate cancer remains a major concern among black men due to disproportionate incidence and mortality.
• Developing prostate cancer screening recommendations for black men would help reduce mortality and morbidity in this population.
• Educating black men about screening for prostate cancer at an earlier age may help them to make informed decisions later in life.

IMPLICATIONS FOR PRACTICE

The age at which men should begin screening for prostate cancer has been a source of controversy due to the lack of consensus between the American Cancer Society, the American Urological Association, and the United States Preventive Services Task Force (USPSTF) guidelines (see Table).^16-18 The current USPSTF recommendations for prostate cancer screening do not take into account ethnic differences, despite the identified racial disparity.¹⁹ Ambiguity in public health policy creates a quandary in the decision-making process regarding testing and treatment.^9,19,20

Early screening and intervention is necessary to help mitigate prostate cancer morbidity and mortality.²¹The authors support the use of the American Cancer Society guidelines, which are comprehensive and clearly define who is considered to be at risk. The guidelines suggest screening black men and men with known family histories (considered to be at high risk) at age 45, and screening men with a strong family history (multiple first-degree relatives who developed prostate cancer at a young age) beginning at age 40.

In addition, these guidelines recommend the use of both the DRE and PSA screening tests. Screening should be performed every two years for men who have a PSA level < 2.5 ng/mL, and every year for men who have a level > 2.5 ng/mL.

Continue to: TREATMENT

Fortunately, there are several treatment options for men who are diagnosed with prostate cancer.²² These include watchful waiting, surgery, radiation, cryotherapy, hormone therapy, and chemotherapy. The type of treatment chosen depends on many factors, such as the tumor grade or cancer stage, the implications for quality of life, and the shared provider/patient decision-making process. Indeed, choosing the right treatment is a specialized approach that varies according to case and circumstance.²²

CONCLUSION

There has been an increase in prostate cancer screening in recent years. However, black men still lag behind when it comes to having DRE and PSA tests. Many factors, including cultural perceptions of medical care among black men, often cause delays in seeking evaluation and treatment. Developing consistent and uniform prostate cancer screening recommendations for black men would be an important step in reducing mortality and morbidity in this population.

IN THIS ARTICLE

• Prostate cancer screening tools
• Ethic disparities
• Screening guidance

Prostate cancer, the second most common cancer to affect American men, is a slow-growing cancer that is curable when detected early. While the overall incidence has declined in the past 20 years (see Figure 1), prostate cancer remains a major concern among black men due to disproportionate incidence and mortality rates.^1-3 A general understanding of the prostate and of prostate cancer lays the groundwork to acknowledge and address this divide.

ANATOMY OF THE PROSTATE

Although most men know where the prostate gland is located, many do not understand how it functions.⁴ The largest accessory gland of the male reproductive system, the prostate is located below the bladder and in front of the rectum (see Figure 2).⁵ The urethra passes through this gland; therefore, enlargement of the prostate can cause constriction of the urethra, which can affect the ability to eliminate urine from the body.⁵

The prostate is broken down into four distinct regions (see Figure 3). Certain types of inflammation may occur more often in some regions of the prostate than others; as such, 75% of prostate cancer occurs in the peripheral zone (the region located closest to the rectal wall).^5,6

DIAGNOSING PROSTATE CANCER

Signs and symptoms

According to the CDC, the signs and symptoms of prostate cancer include

• Difficulty starting urination
• Weak or interrupted flow of urine
• Frequent urination (especially at night)
• Difficulty emptying the bladder
• Pain or burning during urination
• Blood in the urine or semen
• Pain in the back, hips, or pelvis
• Painful ejaculation.

However, none of these signs and symptoms are unique to prostate cancer.⁷ For instance, difficulty starting urination, weak or interrupted flow of urine, and frequent urination can also be attributed to benign prostatic hyperplasia. Further, in its early stages, prostate cancer may not exhibit any signs or symptoms, making accurate screening essential for detection and treatment.⁷

Screening tools

There are two primary tools for detection of prostate cancer: the prostate-specific antigen (PSA) test and the digital rectal exam (DRE).⁸ The blood test for PSA is routinely used as a screening tool and is therefore considered a standard test for prostate cancer.⁹ A PSA level above 4.0 ng/mL is considered abnormal.¹⁰ Although measuring the PSA level can improve the odds of early prostate cancer detection, there is considerable debate over its dependability in this regard, as PSA can be elevated for benign reasons.

Sociocultural and genetic risk factors

While both black and white men are at an increased risk for prostate cancer if a first-degree relative (ie, father, brother, son) had the disease, one in five black men will develop prostate cancer in their lifetimes, compared with one in seven white men.³ And despite a five-year survival rate of nearly 100% for regional prostate cancer, black men are more than two times as likely as white men to die of the disease (1 in 23 and 1 in 38, respectively).^8,11 From 2011 to 2015, the age-adjusted mortality rate of prostate cancer among black men was 40.8, versus 18.2 for non-Hispanic white men (per 100,000 population).¹²

Continue to: The disparity in prostate cancer mortality...

The disparity in prostate cancer mortality among black men has been attributed to multiple variables. Cultural differences can play a role in whether patients choose to undergo prostate cancer screening. Black men are, for example, less likely than other men to participate in preventive health care practices.¹³ Although an in-depth discussion is outside the scope of this article, researchers have identified some plausible factors for this, including economic limitations, lack of access to health care, distrust of the health care system, and an indifference to pain or discomfort.^13,14 Decisions surrounding prostate screening can also be affected by a patient’s perceived risk for prostate cancer, the impact of a cancer diagnosis, and the availability of treatment.

Other factors that contribute to the higher incidence and mortality rate among black men include genetic predisposition, health beliefs, and knowledge about the prostate and cancer screenings.¹⁵ While most researchers have focused on men ages 40 and older, Ogunsanya et al suggested that educating black men about screening for prostate cancer at an earlier age may help them to make informed decisions later in life.¹⁵

PRACTICE POINTS

• Prostate cancer remains a major concern among black men due to disproportionate incidence and mortality.
• Developing prostate cancer screening recommendations for black men would help reduce mortality and morbidity in this population.
• Educating black men about screening for prostate cancer at an earlier age may help them to make informed decisions later in life.

IMPLICATIONS FOR PRACTICE

The age at which men should begin screening for prostate cancer has been a source of controversy due to the lack of consensus between the American Cancer Society, the American Urological Association, and the United States Preventive Services Task Force (USPSTF) guidelines (see Table).^16-18 The current USPSTF recommendations for prostate cancer screening do not take into account ethnic differences, despite the identified racial disparity.¹⁹ Ambiguity in public health policy creates a quandary in the decision-making process regarding testing and treatment.^9,19,20

Early screening and intervention is necessary to help mitigate prostate cancer morbidity and mortality.²¹The authors support the use of the American Cancer Society guidelines, which are comprehensive and clearly define who is considered to be at risk. The guidelines suggest screening black men and men with known family histories (considered to be at high risk) at age 45, and screening men with a strong family history (multiple first-degree relatives who developed prostate cancer at a young age) beginning at age 40.

In addition, these guidelines recommend the use of both the DRE and PSA screening tests. Screening should be performed every two years for men who have a PSA level < 2.5 ng/mL, and every year for men who have a level > 2.5 ng/mL.

Continue to: TREATMENT

Fortunately, there are several treatment options for men who are diagnosed with prostate cancer.²² These include watchful waiting, surgery, radiation, cryotherapy, hormone therapy, and chemotherapy. The type of treatment chosen depends on many factors, such as the tumor grade or cancer stage, the implications for quality of life, and the shared provider/patient decision-making process. Indeed, choosing the right treatment is a specialized approach that varies according to case and circumstance.²²

CONCLUSION

There has been an increase in prostate cancer screening in recent years. However, black men still lag behind when it comes to having DRE and PSA tests. Many factors, including cultural perceptions of medical care among black men, often cause delays in seeking evaluation and treatment. Developing consistent and uniform prostate cancer screening recommendations for black men would be an important step in reducing mortality and morbidity in this population.

Nationwide bans on corporal punishment of children in the home and school seem to have had a positive impact on fighting among adolescents, with males in those countries about 30% less likely to engage in fighting and females almost 60% less likely to do so, according to a study of school-based health surveys completed by 403,604 adolescents in 88 different countries published in BMJ Open.

“These findings add to a growing body of evidence on links between corporal punishment and adolescent health and safety. A growing number of countries have banned corporal punishment as an acceptable means of child discipline, and this is an important step that should be encouraged,” said Frank J. Elgar, PhD, of McGill University in Montreal and his colleagues. “Health providers are well positioned to offer practical and effective tools that support such approaches to child discipline. Cultural shifts from punitive to positive discipline happen slowly.”

The researchers placed countries into three categories: those that have banned corporate punishment in the home and at school; those that have banned it in school only (which include the United States, Canada, and the United Kingdom); and those that have not banned corporal punishment in either setting.

Frequent fighting rates varied widely, Dr. Elgar and his colleagues noted, ranging from a low of less than 1% among females in Costa Rica, which bans all forms of corporal punishment, to a high of 35% among males in Samoa, which allows corporal punishment in both settings.

The 30 countries with full bans had rates of fighting 31% lower in males and 58% lower in females than the 20 countries with no ban. Thirty-eight countries with bans in schools but not in the home reported less fighting in females only – 44% lower than countries without bans.

The reasons for the gender difference in fighting rates among countries with partial bans is unclear, the authors said. “It could be that males, compared with females, experience more physical violence outside school settings or are affected differently by corporal punishment by teachers,” Dr. Elgar and his coauthors said. “Further investigation is needed.”

The study analyzed findings of two well-established surveys used internationally to measure fighting among adolescents: the World Health Organization Health Behavior in School-aged Children (HBSC) study and the Global School-based Health Survey (GSHS). The former is conducted among children ages 11, 13, and 15 in Canada, the United States, and most European countries every 4 years. The GSHS measures fighting among children aged 13-17 years in 55 low- and middle-income countries.

Among the limitations the study authors acknowledged was the inability to account for when the surveys were completed and when the bans were implemented, enforced, or modified, but they also pointed out the large and diverse sample of countries as a strength of the study.

Dr. Elgar and coauthors reported having no financial relationships. The work was supported by grants from the Canadian Institutes for Health Research, the Social Sciences and Humanities Research Council, and the Canada Research Chairs programme.

SOURCE: Elgar FJ et al. BMJ Open. 2018;8:e021616.

Nationwide bans on corporal punishment of children in the home and school seem to have had a positive impact on fighting among adolescents, with males in those countries about 30% less likely to engage in fighting and females almost 60% less likely to do so, according to a study of school-based health surveys completed by 403,604 adolescents in 88 different countries published in BMJ Open.

“These findings add to a growing body of evidence on links between corporal punishment and adolescent health and safety. A growing number of countries have banned corporal punishment as an acceptable means of child discipline, and this is an important step that should be encouraged,” said Frank J. Elgar, PhD, of McGill University in Montreal and his colleagues. “Health providers are well positioned to offer practical and effective tools that support such approaches to child discipline. Cultural shifts from punitive to positive discipline happen slowly.”

The researchers placed countries into three categories: those that have banned corporate punishment in the home and at school; those that have banned it in school only (which include the United States, Canada, and the United Kingdom); and those that have not banned corporal punishment in either setting.

Frequent fighting rates varied widely, Dr. Elgar and his colleagues noted, ranging from a low of less than 1% among females in Costa Rica, which bans all forms of corporal punishment, to a high of 35% among males in Samoa, which allows corporal punishment in both settings.

The 30 countries with full bans had rates of fighting 31% lower in males and 58% lower in females than the 20 countries with no ban. Thirty-eight countries with bans in schools but not in the home reported less fighting in females only – 44% lower than countries without bans.

The reasons for the gender difference in fighting rates among countries with partial bans is unclear, the authors said. “It could be that males, compared with females, experience more physical violence outside school settings or are affected differently by corporal punishment by teachers,” Dr. Elgar and his coauthors said. “Further investigation is needed.”

The study analyzed findings of two well-established surveys used internationally to measure fighting among adolescents: the World Health Organization Health Behavior in School-aged Children (HBSC) study and the Global School-based Health Survey (GSHS). The former is conducted among children ages 11, 13, and 15 in Canada, the United States, and most European countries every 4 years. The GSHS measures fighting among children aged 13-17 years in 55 low- and middle-income countries.

Among the limitations the study authors acknowledged was the inability to account for when the surveys were completed and when the bans were implemented, enforced, or modified, but they also pointed out the large and diverse sample of countries as a strength of the study.

Dr. Elgar and coauthors reported having no financial relationships. The work was supported by grants from the Canadian Institutes for Health Research, the Social Sciences and Humanities Research Council, and the Canada Research Chairs programme.

SOURCE: Elgar FJ et al. BMJ Open. 2018;8:e021616.

Nationwide bans on corporal punishment of children in the home and school seem to have had a positive impact on fighting among adolescents, with males in those countries about 30% less likely to engage in fighting and females almost 60% less likely to do so, according to a study of school-based health surveys completed by 403,604 adolescents in 88 different countries published in BMJ Open.

“These findings add to a growing body of evidence on links between corporal punishment and adolescent health and safety. A growing number of countries have banned corporal punishment as an acceptable means of child discipline, and this is an important step that should be encouraged,” said Frank J. Elgar, PhD, of McGill University in Montreal and his colleagues. “Health providers are well positioned to offer practical and effective tools that support such approaches to child discipline. Cultural shifts from punitive to positive discipline happen slowly.”

The researchers placed countries into three categories: those that have banned corporate punishment in the home and at school; those that have banned it in school only (which include the United States, Canada, and the United Kingdom); and those that have not banned corporal punishment in either setting.

Frequent fighting rates varied widely, Dr. Elgar and his colleagues noted, ranging from a low of less than 1% among females in Costa Rica, which bans all forms of corporal punishment, to a high of 35% among males in Samoa, which allows corporal punishment in both settings.

The 30 countries with full bans had rates of fighting 31% lower in males and 58% lower in females than the 20 countries with no ban. Thirty-eight countries with bans in schools but not in the home reported less fighting in females only – 44% lower than countries without bans.

The reasons for the gender difference in fighting rates among countries with partial bans is unclear, the authors said. “It could be that males, compared with females, experience more physical violence outside school settings or are affected differently by corporal punishment by teachers,” Dr. Elgar and his coauthors said. “Further investigation is needed.”

The study analyzed findings of two well-established surveys used internationally to measure fighting among adolescents: the World Health Organization Health Behavior in School-aged Children (HBSC) study and the Global School-based Health Survey (GSHS). The former is conducted among children ages 11, 13, and 15 in Canada, the United States, and most European countries every 4 years. The GSHS measures fighting among children aged 13-17 years in 55 low- and middle-income countries.

Among the limitations the study authors acknowledged was the inability to account for when the surveys were completed and when the bans were implemented, enforced, or modified, but they also pointed out the large and diverse sample of countries as a strength of the study.

Dr. Elgar and coauthors reported having no financial relationships. The work was supported by grants from the Canadian Institutes for Health Research, the Social Sciences and Humanities Research Council, and the Canada Research Chairs programme.

SOURCE: Elgar FJ et al. BMJ Open. 2018;8:e021616.

Adults aged 65 years and older with a self-harm history are more likely to die from unnatural causes – specifically suicide – than are those who do not self-harm, according to what researchers called the first study of self-harm that exclusively focused on older adults from the perspective of primary care.

giocalde/Thinkstock

“This work should alert policy makers and primary health care professionals to progress towards implementing preventive measures among older adults who consult with a GP,” lead author Catharine Morgan, PhD, and her coauthors, wrote in the Lancet Psychiatry.

The study, which reviewed the primary care records of 4,124 older adults in the United Kingdom with incidents of self-harm, found that older adults were infrequently referred to mental health specialists while being prescribed potentially toxic tricyclic antidepressants at a high proportion, said Dr. Morgan, of the National Institute for Health Research (NIHR) Greater Manchester (England) Patient Safety Translational Research Centre at the University of Manchester, and her coauthors. They also noted that, “compared with their peers who had not harmed themselves, adults in the self-harm cohort were an estimated 20 times more likely to die unnaturally during the first year after a self-harm episode and three or four times more likely to die unnaturally in subsequent years.”

The coauthors also found that, compared with a comparison cohort, the prevalence of a previous mental illness was twice as high among older adults who had engaged in self-harm (hazard ratio, 2.10; 95% confidence interval, 2.03-2.17). Older adults with a self-harm history also had a 20% higher prevalence of a physical illness (HR, 1.20; 95% CI, 1.17-1.23), compared with those without such a history.

Dr. Morgan and her coauthors also uncovered differing likelihoods of referral to specialists, depending on socioeconomic status of the surrounding area. Older patients in “more socially deprived localities” were less likely to be referred to mental health services. Women also were more likely than men were to be referred, highlighting “an important target for improvement across the health care system.” They also recommended avoiding tricyclics for older patients and encouraged maintaining “frequent medication reviews after self-harm.”

The coauthors noted potential limitations in their study, including reliance on clinicians who entered the primary care records and reluctance of coroners to report suicide as the cause of death in certain scenarios. However, they strongly encouraged general practitioners to intervene early and consider alternative medications when treating older patients who exhibit risk factors.

“Health care professionals should take the opportunity to consider the risk of self-harm when an older person consults with other health problems, especially when major physical illnesses and psychopathology are both present, to reduce the risk of an escalation in self-harming behaviour and associated mortality,” they wrote.

The NIHR Greater Manchester Patient Safety Translational Research Centre funded the study. Dr. Morgan and three of her coauthors declared no conflicts of interest. Two authors reported grants from the NIHR, and one author reported grants from the Department of Health and Social Care and the Healthcare Quality Improvement Partnership.

SOURCE: Morgan C et al. Lancet Psychiatry. 2018 Oct 15. doi: 10.1016/S2215-0366(18)30348-1.

Adults aged 65 years and older with a self-harm history are more likely to die from unnatural causes – specifically suicide – than are those who do not self-harm, according to what researchers called the first study of self-harm that exclusively focused on older adults from the perspective of primary care.

giocalde/Thinkstock

“This work should alert policy makers and primary health care professionals to progress towards implementing preventive measures among older adults who consult with a GP,” lead author Catharine Morgan, PhD, and her coauthors, wrote in the Lancet Psychiatry.

The study, which reviewed the primary care records of 4,124 older adults in the United Kingdom with incidents of self-harm, found that older adults were infrequently referred to mental health specialists while being prescribed potentially toxic tricyclic antidepressants at a high proportion, said Dr. Morgan, of the National Institute for Health Research (NIHR) Greater Manchester (England) Patient Safety Translational Research Centre at the University of Manchester, and her coauthors. They also noted that, “compared with their peers who had not harmed themselves, adults in the self-harm cohort were an estimated 20 times more likely to die unnaturally during the first year after a self-harm episode and three or four times more likely to die unnaturally in subsequent years.”

The coauthors also found that, compared with a comparison cohort, the prevalence of a previous mental illness was twice as high among older adults who had engaged in self-harm (hazard ratio, 2.10; 95% confidence interval, 2.03-2.17). Older adults with a self-harm history also had a 20% higher prevalence of a physical illness (HR, 1.20; 95% CI, 1.17-1.23), compared with those without such a history.

Dr. Morgan and her coauthors also uncovered differing likelihoods of referral to specialists, depending on socioeconomic status of the surrounding area. Older patients in “more socially deprived localities” were less likely to be referred to mental health services. Women also were more likely than men were to be referred, highlighting “an important target for improvement across the health care system.” They also recommended avoiding tricyclics for older patients and encouraged maintaining “frequent medication reviews after self-harm.”

The coauthors noted potential limitations in their study, including reliance on clinicians who entered the primary care records and reluctance of coroners to report suicide as the cause of death in certain scenarios. However, they strongly encouraged general practitioners to intervene early and consider alternative medications when treating older patients who exhibit risk factors.

“Health care professionals should take the opportunity to consider the risk of self-harm when an older person consults with other health problems, especially when major physical illnesses and psychopathology are both present, to reduce the risk of an escalation in self-harming behaviour and associated mortality,” they wrote.

The NIHR Greater Manchester Patient Safety Translational Research Centre funded the study. Dr. Morgan and three of her coauthors declared no conflicts of interest. Two authors reported grants from the NIHR, and one author reported grants from the Department of Health and Social Care and the Healthcare Quality Improvement Partnership.

SOURCE: Morgan C et al. Lancet Psychiatry. 2018 Oct 15. doi: 10.1016/S2215-0366(18)30348-1.

Adults aged 65 years and older with a self-harm history are more likely to die from unnatural causes – specifically suicide – than are those who do not self-harm, according to what researchers called the first study of self-harm that exclusively focused on older adults from the perspective of primary care.

giocalde/Thinkstock

“This work should alert policy makers and primary health care professionals to progress towards implementing preventive measures among older adults who consult with a GP,” lead author Catharine Morgan, PhD, and her coauthors, wrote in the Lancet Psychiatry.

The study, which reviewed the primary care records of 4,124 older adults in the United Kingdom with incidents of self-harm, found that older adults were infrequently referred to mental health specialists while being prescribed potentially toxic tricyclic antidepressants at a high proportion, said Dr. Morgan, of the National Institute for Health Research (NIHR) Greater Manchester (England) Patient Safety Translational Research Centre at the University of Manchester, and her coauthors. They also noted that, “compared with their peers who had not harmed themselves, adults in the self-harm cohort were an estimated 20 times more likely to die unnaturally during the first year after a self-harm episode and three or four times more likely to die unnaturally in subsequent years.”

The coauthors also found that, compared with a comparison cohort, the prevalence of a previous mental illness was twice as high among older adults who had engaged in self-harm (hazard ratio, 2.10; 95% confidence interval, 2.03-2.17). Older adults with a self-harm history also had a 20% higher prevalence of a physical illness (HR, 1.20; 95% CI, 1.17-1.23), compared with those without such a history.

Dr. Morgan and her coauthors also uncovered differing likelihoods of referral to specialists, depending on socioeconomic status of the surrounding area. Older patients in “more socially deprived localities” were less likely to be referred to mental health services. Women also were more likely than men were to be referred, highlighting “an important target for improvement across the health care system.” They also recommended avoiding tricyclics for older patients and encouraged maintaining “frequent medication reviews after self-harm.”

The coauthors noted potential limitations in their study, including reliance on clinicians who entered the primary care records and reluctance of coroners to report suicide as the cause of death in certain scenarios. However, they strongly encouraged general practitioners to intervene early and consider alternative medications when treating older patients who exhibit risk factors.

“Health care professionals should take the opportunity to consider the risk of self-harm when an older person consults with other health problems, especially when major physical illnesses and psychopathology are both present, to reduce the risk of an escalation in self-harming behaviour and associated mortality,” they wrote.

The NIHR Greater Manchester Patient Safety Translational Research Centre funded the study. Dr. Morgan and three of her coauthors declared no conflicts of interest. Two authors reported grants from the NIHR, and one author reported grants from the Department of Health and Social Care and the Healthcare Quality Improvement Partnership.

SOURCE: Morgan C et al. Lancet Psychiatry. 2018 Oct 15. doi: 10.1016/S2215-0366(18)30348-1.