Studies of the transition of care between inpatient and outpatient settings have shown that there are significant patient safety and quality deficiencies in our current system. The transition from the hospital setting to the outpatient setting has been more extensively studied than the transition from the outpatient setting to the inpatient setting. One prospective cohort study of 400 patients found that 1 in 5 patients discharged from the hospital to home experienced an adverse event, which was defined as an injury resulting from medical management rather than the underlying disease, within 3 weeks of discharge.1 This study also concluded that 66% of these were drug‐related adverse events, many of which could have been avoided or mitigated. Another prospective cross‐sectional study of 2644 patient discharges found that approximately 40% of the patients had pending test results at the time of discharge and that 10% of these required some action, yet the outpatient physicians and patients were unaware of these results.2 Medication discrepancies have also been shown to be prevalent, with 1 prospective observational study of 375 patients showing that 14% of elderly patients had 1 or more medication discrepancies and 14% of those patients with medication discrepancies were rehospitalized within 30 days versus 6% of the patients who did not experience a medication discrepancy.3 A recent review of the literature cited improving transitional care as a key area of opportunity for improving postdischarge care4

Lack of communication has clearly been shown to adversely affect postdischarge care transitions.5 A recent summary of the literature by a Society of Hospital Medicine (SHM)/Society of General Internal Medicine (SGIM) task force found that direct communication between hospital physicians and primary care physicians occurs infrequently (in 3%‐20% of cases studied), and the availability of a discharge summary at the first postdischarge visit is low (12%‐34%) and does not improve greatly even after 4 weeks (51%‐77%); this affects the quality of care in approximately 25% of follow‐up visits.5 This systematic review of the literature also found that discharge summaries often lack important information such as diagnostic test results, the treatment or hospital course, discharge medications, test results pending at discharge, patient or family counseling, and follow‐up plans.

However, the lack of studies of the communication between ambulatory physicians and hospital physicians prior to admission or during emergency department (ED) visits does not imply that this communication is not equally important and essential to high‐quality care. According to the Centers for Disease Control, the greatest source of hospital admissions in many institutions is the ED. Over 115,000,000 visits were made to the nation's approximately 4828 EDs in 2005, and about 85.2% of ED visits end in discharge.6 The ED is also the point of re‐entry into the system for individuals who may have had an adverse outcome linked to a prior hospitalization.6 Communication between hospital physicians and primary care physicians must be established to create a loop of continuous care and diminish morbidity and mortality at this critical transition point.

While transitions can be a risky period for patient safety, observational studies suggest there are benefits to transitions. A new physician may notice something overlooked by the current caregivers.712 Another factor contributing to the challenges of care transitions is the lack of a single clinician or clinical entity taking responsibility for coordination across the continuum of the patient's overall healthcare, regardless of setting.13 Studies indicate that a relationship with a medical home is associated with better health on both the individual and population levels, with lower overall costs of care and with reductions in disparities in health between socially disadvantaged subpopulations and more socially advantaged populations.14 Several medical societies have addressed this issue, including the American College of Physicians (ACP), SGIM, American Academy of Family Physicians, and American Academy of Pediatrics, and they have proposed the concept of the medical home or patient‐centered medical home, which calls for clinicians to assume this responsibility for coordinating their patients' care across settings and for the healthcare system to value and reimburse clinicians for this patient‐centered and comprehensive method of practice.1517

Finally, patients and their families or caregivers have an important role to play in transitions of care. Several observational and cross‐sectional studies have shown that patients and their caregivers and families express significant feelings of anxiety during care transitions. This anxiety can be caused by a lack of understanding and preparation for their self‐care role in the next care setting, confusion due to conflicting advice from different practitioners, and a sense of abandonment attributable to the inability to contact an appropriate healthcare practitioner for guidance, and they report an overall disregard for their preferences and input into the design of the care plan.1820 Clearly, there is room for improvement in all these areas of the inpatient and outpatient care transition, and the Transitions of Care Consensus Conference (TOCCC) attempted to address these areas by developing standards for the transition of care that also harmonize with the work of the Stepping up to the Plate (SUTTP) Alliance of the American Board of Internal Medicine (ABIM) Foundation.21 In addition, other important stakeholders are addressing this topic and actively working to improve communication and continuity in care, including the Centers for Medicare and Medicaid Services (CMS) and the National Quality Forum (NQF). CMS recently developed the Continuity Assessment Record & Evaluation (CARE) tool, a data collection instrument designed to be a standardized, interoperable, common assessment tool to capture key patient characteristics that will provide information related to resource utilization, clinical outcomes, and postdischarge disposition. NQF held a national forum on care coordination in the spring of 2008.

In summary, it is clear that there are qualitative and quantitative deficiencies in transitions of care between the inpatient and outpatient setting that are affecting patient safety and experience with care. The transition from the inpatient setting to the outpatient setting has been more extensively studied, and this body of literature has underscored for the TOCCC several important areas in need of guidance and improvement. Because of this, the scope of application of this document should initially emphasize inpatient‐to‐outpatient transitions as a first step in learning how to improve these processes. However, the transition from the outpatient setting to the inpatient setting also is a clear priority. Because the needs for transfer of information, authority, and responsibility may be different in these situations, a second phase of additional work to develop principles to guide these transitions should be undertaken as quickly as possible. Experience gained in applying these principles to inpatient‐to‐outpatient transitions might usefully inform such work.

Communication among providers and with the patients and their families arose as a clear priority. Medication discrepancies, pending tests, and unknown diagnostic or treatment plans have an immediate impact on patients' health and outcomes. The TOCCC discussed what elements should be among the standard pieces of information exchanged among providers during these transition points. The dire need for coordination of care or a coordinating clinician/medical home became a clear theme in the deliberations of the TOCCC. Most importantly, the role of the patients and their families/caregivers in their continuing care is apparent, and the TOCCC felt this must be an integral part of any principles or standards for transitions of care.

Methods

In the fall/winter of 2006, the executive committees of ACP, SGIM, and SHM agreed to jointly develop a policy statement on transitions of care. Transitions of care specifically between the inpatient and outpatient settings were selected as an ideal topic for collaboration for the 3 societies as they represent the continuum of care for internal medicine within these settings. To accomplish this, the 3 organizations decided to convene a consensus conference to develop consensus guidelines and standards concerning transitions between inpatient and outpatient settings through a multi‐stakeholder process. A steering committee was convened with representatives from ACP, SGIM, SHM, the Agency for Healthcare Research and Quality (AHRQ), ABIM, and the American Geriatric Society (AGS). The steering committee developed the agenda and invitee list for the consensus conference. After the conference was held, the steering committee was expanded to include representation from the American College of Emergency Physicians (ACEP) and the Society for Academic Emergency Medicine (SAEM).

During the planning stages of the TOCCC, the steering committee became aware of the SUTTP Alliance of the ABIM Foundation. The SUTTP Alliance has representation from medical specialties such as internal medicine and its subspecialties, family medicine, and surgery. The alliance was formed in 2006 and has been working on care coordination across multiple settings and specialties. The SUTTP Alliance had developed a set of principles and standards for care transitions and agreed to provide the draft document to the TOCCC for review, input, and further development and refinement.

Recommendations on Principles and Standards for Managing Transitions in Care Between the Inpatient and Outpatient Settings from ACP, SGIM, SHM, AGS, ACEP, and SAEM

The SUTTP Alliance presented a draft document entitled Principles and Standards for Managing Transitions in Care. In this document, the SUTTP Alliance proposes 5 principles and 8 standards for effective care transitions. A key element of the conference was a presentation by NQF on how to move from principles to standards and eventually to measures. This presentation provided the TOCCC with the theoretical underpinnings for the discussion of these principles and standards and how the TOCCC would provide input on them. The presentation provided an outline for the flow from principles to measures. First, there needs to be a framework that provides guiding principles for what we would like to measure and eventually report. From those principles, a set of preferred practices or standards are developed; the standards are more granular and allow for more specificity in describing the desired practice or outcome and its elements. Standards then provide a roadmap for identification and development of performance measures. With this framework in mind, the TOCCC then discussed in detail the SUTTP principles and standards.

The 5 principles for effective care transitions developed by the SUTTP Alliance are as follows:

• Accountability.

• Communication: clear and direct communication of treatment plans and follow‐up expectations.

• Timely feedback and feed‐forward of information.

• Involvement of the patient and family member, unless inappropriate, in all steps.

• Respect of the hub of coordination of care.

The TOCCC re‐affirmed these principles and added 4 additional principles to this list. Three of the new principles were statements within the 8 standards developed by the SUTTP, but when taking into consideration the framework for the development of principles into standards, the TOCCC felt that the statements were better represented as principles. They are as follows:

• All patients and their families/caregivers should have and should be able to identify their medical home or coordinating clinician (ie, practice or practitioner). (This was originally part of the coordinating clinicians standard, and the TOCCC voted to elevate this to a principle).

• At every point along the transition, the patients and/or their families/caregivers need to know who is responsible for care at that point and who to contact and how.

• National standards should be established for transitions in care and should be adopted and implemented at the national and community level through public health institutions, national accreditation bodies, medical societies, medical institutions, and so forth in order to improve patient outcomes and patient safety. (This was originally part of the SUTTP community standards standard, and the TOCCC moved to elevate this to a principle).

• For monitoring and improving transitions, standardized metrics related to these standards should be used in order to lead to continuous quality improvement and accountability. (This was originally part of the measurement standard, and the TOCCC voted to elevate this to a principle).

The SUTTP Alliance proposed the following 8 standards for care transitions:

• Coordinating clinicians.

• Care plans.

• Communication infrastructure.

• Standard communication formats.

• Transition responsibility.

• Timeliness.

• Community standards.

• Measurement.

The TOCCC affirmed these standards and through a consensus process added more specificity to most of them and elevated components of some of them to principles, as discussed previously. The TOCCC proposes that the following be merged with the SUTTP standards:

• Coordinating clinicians. Communication and information exchange between the medical home and the receiving provider should occur in an amount of time that will allow the receiving provider to effectively treat the patient. This communication and information exchange should ideally occur whenever patients are at a transition of care (eg, at discharge from the inpatient setting). The timeliness of this communication should be consistent with the patient's clinical presentation and, in the case of a patient being discharged, the urgency of the follow‐up required. Guidelines will need to be developed that address both the timeliness and means of communication between the discharging physician and the medical home. Communication and information exchange between the medical home and other physicians may be in the form of a call, voice mail, fax, or other secure, private, and accessible means including mutual access to an electronic health record.

  The ED represents a unique subset of transitions of care. The potential transition can generally be described as outpatient to outpatient or outpatient to inpatient, depending on whether or not the patient is admitted to the hospital. The outpatient‐to‐outpatient transition can also encompass a number of potential variations. Patients with a medical home may be referred to the ED by the medical home, or they may self‐refer. A significant number of patients do not have a physician and self‐refer to the ED. The disposition from the ED, either outpatient to outpatient or outpatient to inpatient, is similarly represented by a number of variables. Discharged patients may or may not have a medical home, may or may not need a specialist, and may or may not require urgent (<24 hours) follow‐up. Admitted patients may or may not have a medical home and may or may not require specialty care. This variety of variables precludes a single approach to ED transition of care coordination. The determination of which scenarios will be appropriate for the development of standards (coordinating clinicians and transition responsibility) will require further contributions from ACEP and SAEM and review by the steering committee.

• Care plans/transition record. The TOCCC also agreed that there is a minimal set of data elements that should always be part of the transition record. The TOCCC suggested that this minimal data set be part of an initial implementation of this standard. That list includes the following:

  The TOCCC discussed what components should be included in an ideal transition record and agreed on the following elements:

  The TOCCC also added a new standard under this heading: Patients and/or their families/caregivers must receive, understand, and be encouraged to participate in the development of the transition record, which should take into consideration patients' health literacy and insurance status and be culturally sensitive.

• Principle diagnosis and problem list.

• Medication list (reconciliation) including over‐the‐counter medications/herbals, allergies, and drug interactions.

• Clear identification of the medical home/transferring coordinating physician/emnstitution and the contact information.

• Patient's cognitive status.

• Test results/pending results.

• Principle diagnosis and problem list.

• Medication list (reconciliation) including over‐the‐counter medications/herbals, allergies, and drug interactions.

• Emergency plan and contact number and person.

• Treatment and diagnostic plan.

• Prognosis and goals of care.

• Test results/pending results.

• Clear identification of the medical home and/or transferring coordinating physician/emnstitution.

• Patient's cognitive status.

• Advance directives, power of attorney, and consent.

• Planned interventions, durable medical equipment, wound care, and so forth.

• Assessment of caregiver status.

• Communication infrastructure. All communications between providers and between providers and patients and families/caregivers need to be secure, private, Health Insurance Portability and Accountability Actcompliant, and accessible to patients and those practitioners who care for them. Communication needs to be 2‐way with an opportunity for clarification and feedback. Each sending provider needs to provide a contact name and the number of an individual who can respond to questions or concerns. The content of transferred information needs to include a core standardized data set. This information needs to be transferred as a living database; that is, it is created only once, and then each subsequent provider only needs to update, validate, or modify the information. Patient information should be available to the provider prior to the patient's arrival. Information transfer needs to adhere to national data standards. Patients should be provided with a medication list that is accessible (paper or electronic), clear, and dated.

• Standard communication formats. Communities need to develop standard data transfer forms (templates and transmission protocols). Access to a patient's medical history needs to be on a current and ongoing basis with the ability to modify information as a patient's condition changes. Patients, families, and caregivers should have access to their information (nothing about me without me). A section on the transfer record should be devoted to communicating a patient's preferences, priorities, goals, and values (eg, the patient does not want intubation).

• Transition responsibility. The sending provider/emnstitution/team at the clinical organization maintains responsibility for the care of the patient until the receiving clinician/location confirms that the transfer and assumption of responsibility is complete (within a reasonable timeframe for the receiving clinician to receive the information; ie, transfers that occur in the middle of the night can be communicated during standard working hours). The sending provider should be available for clarification with issues of care within a reasonable timeframe after the transfer has been completed, and this timeframe should be based on the conditions of the transfer settings. The patient should be able to identify the responsible provider. In the case of patients who do not have an ongoing ambulatory care provider or whose ambulatory care provider has not assumed responsibility, the hospital‐based clinicians will not be required to assume responsibility for the care of these patients once they are discharged.

• Timeliness. Timeliness of feedback and feed‐forward of information from a sending provider to a receiving provider should be contingent on 4 factors:

  This information should be available at the time of the patient encounter.

• Transition settings.

• Patient circumstances.

• Level of acuity.

• Clear transition responsibility.

• Community standards. Medical communities/emnstitutions must demonstrate accountability for transitions of care by adopting national standards, and processes should be established to promote effective transitions of care.

• Measurement. For monitoring and improving transitions, standardized metrics related to these standards should be used. These metrics/measures should be evidence‐based, address documented gaps, and have a demonstrated impact on improving care (complying with performance measure standards) whenever feasible. Results from measurements using standardized metrics must lead to continuous improvement of the transition process. The validity, reliability, cost, and impact, including unintended consequences, of these measures should be assessed and re‐evaluated.

All these standards should be applied with special attention to the various transition settings and should be appropriate to each transition setting. Measure developers will need to take this into account when developing measures based on these proposed standards.

The TOCCC also went through a consensus prioritization exercise to rank‐order the consensus standards. All meeting participants were asked to rank their top 3 priorities of the 7 standards, giving a numeric score of 1 for their highest priority, a score of 2 for their second highest priority, and a score of 3 for their third highest priority. Summary scores were calculated, and the standards were rank‐ordered from the lowest summary score to the highest. The TOCCC recognizes that full implementation of all of these standards may not be feasible and that these standards may be implemented on a stepped or incremental basis. This prioritization can assist in deciding which of these to implement. The results of the prioritization exercise are as follows:

• 1

  All transitions must include a transition record

• 2

  Transition responsibility

• 3

  Coordinating clinicians

• 4

  Patient and family involvement and ownership of the transition record

• 5

  Communication infrastructure

• 6

  Timeliness

• 7

  Community standards

Future Challenges

In addition to the work on the principles and standards, the TOCCC uncovered six further challenges which are described below.

Next Steps for the TOCCC

The TOCCC focuses only on the transitions between the inpatient and outpatient settings and does not address the equally important transitions between many other different care settings, such as the transition from a hospital to a nursing home or rehabilitation facility. The intent of the TOCCC is to provide this document to national measure developers such as the Physician Consortium for Performance Improvement and others in order to guide measure development and ultimately lead to improvements in quality and safety in care transitions.

Studies of the transition of care between inpatient and outpatient settings have shown that there are significant patient safety and quality deficiencies in our current system. The transition from the hospital setting to the outpatient setting has been more extensively studied than the transition from the outpatient setting to the inpatient setting. One prospective cohort study of 400 patients found that 1 in 5 patients discharged from the hospital to home experienced an adverse event, which was defined as an injury resulting from medical management rather than the underlying disease, within 3 weeks of discharge.1 This study also concluded that 66% of these were drug‐related adverse events, many of which could have been avoided or mitigated. Another prospective cross‐sectional study of 2644 patient discharges found that approximately 40% of the patients had pending test results at the time of discharge and that 10% of these required some action, yet the outpatient physicians and patients were unaware of these results.2 Medication discrepancies have also been shown to be prevalent, with 1 prospective observational study of 375 patients showing that 14% of elderly patients had 1 or more medication discrepancies and 14% of those patients with medication discrepancies were rehospitalized within 30 days versus 6% of the patients who did not experience a medication discrepancy.3 A recent review of the literature cited improving transitional care as a key area of opportunity for improving postdischarge care4

Lack of communication has clearly been shown to adversely affect postdischarge care transitions.5 A recent summary of the literature by a Society of Hospital Medicine (SHM)/Society of General Internal Medicine (SGIM) task force found that direct communication between hospital physicians and primary care physicians occurs infrequently (in 3%‐20% of cases studied), and the availability of a discharge summary at the first postdischarge visit is low (12%‐34%) and does not improve greatly even after 4 weeks (51%‐77%); this affects the quality of care in approximately 25% of follow‐up visits.5 This systematic review of the literature also found that discharge summaries often lack important information such as diagnostic test results, the treatment or hospital course, discharge medications, test results pending at discharge, patient or family counseling, and follow‐up plans.

However, the lack of studies of the communication between ambulatory physicians and hospital physicians prior to admission or during emergency department (ED) visits does not imply that this communication is not equally important and essential to high‐quality care. According to the Centers for Disease Control, the greatest source of hospital admissions in many institutions is the ED. Over 115,000,000 visits were made to the nation's approximately 4828 EDs in 2005, and about 85.2% of ED visits end in discharge.6 The ED is also the point of re‐entry into the system for individuals who may have had an adverse outcome linked to a prior hospitalization.6 Communication between hospital physicians and primary care physicians must be established to create a loop of continuous care and diminish morbidity and mortality at this critical transition point.

While transitions can be a risky period for patient safety, observational studies suggest there are benefits to transitions. A new physician may notice something overlooked by the current caregivers.712 Another factor contributing to the challenges of care transitions is the lack of a single clinician or clinical entity taking responsibility for coordination across the continuum of the patient's overall healthcare, regardless of setting.13 Studies indicate that a relationship with a medical home is associated with better health on both the individual and population levels, with lower overall costs of care and with reductions in disparities in health between socially disadvantaged subpopulations and more socially advantaged populations.14 Several medical societies have addressed this issue, including the American College of Physicians (ACP), SGIM, American Academy of Family Physicians, and American Academy of Pediatrics, and they have proposed the concept of the medical home or patient‐centered medical home, which calls for clinicians to assume this responsibility for coordinating their patients' care across settings and for the healthcare system to value and reimburse clinicians for this patient‐centered and comprehensive method of practice.1517

Finally, patients and their families or caregivers have an important role to play in transitions of care. Several observational and cross‐sectional studies have shown that patients and their caregivers and families express significant feelings of anxiety during care transitions. This anxiety can be caused by a lack of understanding and preparation for their self‐care role in the next care setting, confusion due to conflicting advice from different practitioners, and a sense of abandonment attributable to the inability to contact an appropriate healthcare practitioner for guidance, and they report an overall disregard for their preferences and input into the design of the care plan.1820 Clearly, there is room for improvement in all these areas of the inpatient and outpatient care transition, and the Transitions of Care Consensus Conference (TOCCC) attempted to address these areas by developing standards for the transition of care that also harmonize with the work of the Stepping up to the Plate (SUTTP) Alliance of the American Board of Internal Medicine (ABIM) Foundation.21 In addition, other important stakeholders are addressing this topic and actively working to improve communication and continuity in care, including the Centers for Medicare and Medicaid Services (CMS) and the National Quality Forum (NQF). CMS recently developed the Continuity Assessment Record & Evaluation (CARE) tool, a data collection instrument designed to be a standardized, interoperable, common assessment tool to capture key patient characteristics that will provide information related to resource utilization, clinical outcomes, and postdischarge disposition. NQF held a national forum on care coordination in the spring of 2008.

In summary, it is clear that there are qualitative and quantitative deficiencies in transitions of care between the inpatient and outpatient setting that are affecting patient safety and experience with care. The transition from the inpatient setting to the outpatient setting has been more extensively studied, and this body of literature has underscored for the TOCCC several important areas in need of guidance and improvement. Because of this, the scope of application of this document should initially emphasize inpatient‐to‐outpatient transitions as a first step in learning how to improve these processes. However, the transition from the outpatient setting to the inpatient setting also is a clear priority. Because the needs for transfer of information, authority, and responsibility may be different in these situations, a second phase of additional work to develop principles to guide these transitions should be undertaken as quickly as possible. Experience gained in applying these principles to inpatient‐to‐outpatient transitions might usefully inform such work.

Communication among providers and with the patients and their families arose as a clear priority. Medication discrepancies, pending tests, and unknown diagnostic or treatment plans have an immediate impact on patients' health and outcomes. The TOCCC discussed what elements should be among the standard pieces of information exchanged among providers during these transition points. The dire need for coordination of care or a coordinating clinician/medical home became a clear theme in the deliberations of the TOCCC. Most importantly, the role of the patients and their families/caregivers in their continuing care is apparent, and the TOCCC felt this must be an integral part of any principles or standards for transitions of care.

Methods

In the fall/winter of 2006, the executive committees of ACP, SGIM, and SHM agreed to jointly develop a policy statement on transitions of care. Transitions of care specifically between the inpatient and outpatient settings were selected as an ideal topic for collaboration for the 3 societies as they represent the continuum of care for internal medicine within these settings. To accomplish this, the 3 organizations decided to convene a consensus conference to develop consensus guidelines and standards concerning transitions between inpatient and outpatient settings through a multi‐stakeholder process. A steering committee was convened with representatives from ACP, SGIM, SHM, the Agency for Healthcare Research and Quality (AHRQ), ABIM, and the American Geriatric Society (AGS). The steering committee developed the agenda and invitee list for the consensus conference. After the conference was held, the steering committee was expanded to include representation from the American College of Emergency Physicians (ACEP) and the Society for Academic Emergency Medicine (SAEM).

During the planning stages of the TOCCC, the steering committee became aware of the SUTTP Alliance of the ABIM Foundation. The SUTTP Alliance has representation from medical specialties such as internal medicine and its subspecialties, family medicine, and surgery. The alliance was formed in 2006 and has been working on care coordination across multiple settings and specialties. The SUTTP Alliance had developed a set of principles and standards for care transitions and agreed to provide the draft document to the TOCCC for review, input, and further development and refinement.

Recommendations on Principles and Standards for Managing Transitions in Care Between the Inpatient and Outpatient Settings from ACP, SGIM, SHM, AGS, ACEP, and SAEM

The SUTTP Alliance presented a draft document entitled Principles and Standards for Managing Transitions in Care. In this document, the SUTTP Alliance proposes 5 principles and 8 standards for effective care transitions. A key element of the conference was a presentation by NQF on how to move from principles to standards and eventually to measures. This presentation provided the TOCCC with the theoretical underpinnings for the discussion of these principles and standards and how the TOCCC would provide input on them. The presentation provided an outline for the flow from principles to measures. First, there needs to be a framework that provides guiding principles for what we would like to measure and eventually report. From those principles, a set of preferred practices or standards are developed; the standards are more granular and allow for more specificity in describing the desired practice or outcome and its elements. Standards then provide a roadmap for identification and development of performance measures. With this framework in mind, the TOCCC then discussed in detail the SUTTP principles and standards.

The 5 principles for effective care transitions developed by the SUTTP Alliance are as follows:

• Accountability.

• Communication: clear and direct communication of treatment plans and follow‐up expectations.

• Timely feedback and feed‐forward of information.

• Involvement of the patient and family member, unless inappropriate, in all steps.

• Respect of the hub of coordination of care.

The TOCCC re‐affirmed these principles and added 4 additional principles to this list. Three of the new principles were statements within the 8 standards developed by the SUTTP, but when taking into consideration the framework for the development of principles into standards, the TOCCC felt that the statements were better represented as principles. They are as follows:

• All patients and their families/caregivers should have and should be able to identify their medical home or coordinating clinician (ie, practice or practitioner). (This was originally part of the coordinating clinicians standard, and the TOCCC voted to elevate this to a principle).

• At every point along the transition, the patients and/or their families/caregivers need to know who is responsible for care at that point and who to contact and how.

• National standards should be established for transitions in care and should be adopted and implemented at the national and community level through public health institutions, national accreditation bodies, medical societies, medical institutions, and so forth in order to improve patient outcomes and patient safety. (This was originally part of the SUTTP community standards standard, and the TOCCC moved to elevate this to a principle).

• For monitoring and improving transitions, standardized metrics related to these standards should be used in order to lead to continuous quality improvement and accountability. (This was originally part of the measurement standard, and the TOCCC voted to elevate this to a principle).

The SUTTP Alliance proposed the following 8 standards for care transitions:

• Coordinating clinicians.

• Care plans.

• Communication infrastructure.

• Standard communication formats.

• Transition responsibility.

• Timeliness.

• Community standards.

• Measurement.

The TOCCC affirmed these standards and through a consensus process added more specificity to most of them and elevated components of some of them to principles, as discussed previously. The TOCCC proposes that the following be merged with the SUTTP standards:

• Coordinating clinicians. Communication and information exchange between the medical home and the receiving provider should occur in an amount of time that will allow the receiving provider to effectively treat the patient. This communication and information exchange should ideally occur whenever patients are at a transition of care (eg, at discharge from the inpatient setting). The timeliness of this communication should be consistent with the patient's clinical presentation and, in the case of a patient being discharged, the urgency of the follow‐up required. Guidelines will need to be developed that address both the timeliness and means of communication between the discharging physician and the medical home. Communication and information exchange between the medical home and other physicians may be in the form of a call, voice mail, fax, or other secure, private, and accessible means including mutual access to an electronic health record.

  The ED represents a unique subset of transitions of care. The potential transition can generally be described as outpatient to outpatient or outpatient to inpatient, depending on whether or not the patient is admitted to the hospital. The outpatient‐to‐outpatient transition can also encompass a number of potential variations. Patients with a medical home may be referred to the ED by the medical home, or they may self‐refer. A significant number of patients do not have a physician and self‐refer to the ED. The disposition from the ED, either outpatient to outpatient or outpatient to inpatient, is similarly represented by a number of variables. Discharged patients may or may not have a medical home, may or may not need a specialist, and may or may not require urgent (<24 hours) follow‐up. Admitted patients may or may not have a medical home and may or may not require specialty care. This variety of variables precludes a single approach to ED transition of care coordination. The determination of which scenarios will be appropriate for the development of standards (coordinating clinicians and transition responsibility) will require further contributions from ACEP and SAEM and review by the steering committee.

• Care plans/transition record. The TOCCC also agreed that there is a minimal set of data elements that should always be part of the transition record. The TOCCC suggested that this minimal data set be part of an initial implementation of this standard. That list includes the following:

  The TOCCC discussed what components should be included in an ideal transition record and agreed on the following elements:

  The TOCCC also added a new standard under this heading: Patients and/or their families/caregivers must receive, understand, and be encouraged to participate in the development of the transition record, which should take into consideration patients' health literacy and insurance status and be culturally sensitive.

• Principle diagnosis and problem list.

• Medication list (reconciliation) including over‐the‐counter medications/herbals, allergies, and drug interactions.

• Clear identification of the medical home/transferring coordinating physician/emnstitution and the contact information.

• Patient's cognitive status.

• Test results/pending results.

• Principle diagnosis and problem list.

• Medication list (reconciliation) including over‐the‐counter medications/herbals, allergies, and drug interactions.

• Emergency plan and contact number and person.

• Treatment and diagnostic plan.

• Prognosis and goals of care.

• Test results/pending results.

• Clear identification of the medical home and/or transferring coordinating physician/emnstitution.

• Patient's cognitive status.

• Advance directives, power of attorney, and consent.

• Planned interventions, durable medical equipment, wound care, and so forth.

• Assessment of caregiver status.

• Communication infrastructure. All communications between providers and between providers and patients and families/caregivers need to be secure, private, Health Insurance Portability and Accountability Actcompliant, and accessible to patients and those practitioners who care for them. Communication needs to be 2‐way with an opportunity for clarification and feedback. Each sending provider needs to provide a contact name and the number of an individual who can respond to questions or concerns. The content of transferred information needs to include a core standardized data set. This information needs to be transferred as a living database; that is, it is created only once, and then each subsequent provider only needs to update, validate, or modify the information. Patient information should be available to the provider prior to the patient's arrival. Information transfer needs to adhere to national data standards. Patients should be provided with a medication list that is accessible (paper or electronic), clear, and dated.

• Standard communication formats. Communities need to develop standard data transfer forms (templates and transmission protocols). Access to a patient's medical history needs to be on a current and ongoing basis with the ability to modify information as a patient's condition changes. Patients, families, and caregivers should have access to their information (nothing about me without me). A section on the transfer record should be devoted to communicating a patient's preferences, priorities, goals, and values (eg, the patient does not want intubation).

• Transition responsibility. The sending provider/emnstitution/team at the clinical organization maintains responsibility for the care of the patient until the receiving clinician/location confirms that the transfer and assumption of responsibility is complete (within a reasonable timeframe for the receiving clinician to receive the information; ie, transfers that occur in the middle of the night can be communicated during standard working hours). The sending provider should be available for clarification with issues of care within a reasonable timeframe after the transfer has been completed, and this timeframe should be based on the conditions of the transfer settings. The patient should be able to identify the responsible provider. In the case of patients who do not have an ongoing ambulatory care provider or whose ambulatory care provider has not assumed responsibility, the hospital‐based clinicians will not be required to assume responsibility for the care of these patients once they are discharged.

• Timeliness. Timeliness of feedback and feed‐forward of information from a sending provider to a receiving provider should be contingent on 4 factors:

  This information should be available at the time of the patient encounter.

• Transition settings.

• Patient circumstances.

• Level of acuity.

• Clear transition responsibility.

• Community standards. Medical communities/emnstitutions must demonstrate accountability for transitions of care by adopting national standards, and processes should be established to promote effective transitions of care.

• Measurement. For monitoring and improving transitions, standardized metrics related to these standards should be used. These metrics/measures should be evidence‐based, address documented gaps, and have a demonstrated impact on improving care (complying with performance measure standards) whenever feasible. Results from measurements using standardized metrics must lead to continuous improvement of the transition process. The validity, reliability, cost, and impact, including unintended consequences, of these measures should be assessed and re‐evaluated.

All these standards should be applied with special attention to the various transition settings and should be appropriate to each transition setting. Measure developers will need to take this into account when developing measures based on these proposed standards.

The TOCCC also went through a consensus prioritization exercise to rank‐order the consensus standards. All meeting participants were asked to rank their top 3 priorities of the 7 standards, giving a numeric score of 1 for their highest priority, a score of 2 for their second highest priority, and a score of 3 for their third highest priority. Summary scores were calculated, and the standards were rank‐ordered from the lowest summary score to the highest. The TOCCC recognizes that full implementation of all of these standards may not be feasible and that these standards may be implemented on a stepped or incremental basis. This prioritization can assist in deciding which of these to implement. The results of the prioritization exercise are as follows:

• 1

  All transitions must include a transition record

• 2

  Transition responsibility

• 3

  Coordinating clinicians

• 4

  Patient and family involvement and ownership of the transition record

• 5

  Communication infrastructure

• 6

  Timeliness

• 7

  Community standards

Future Challenges

In addition to the work on the principles and standards, the TOCCC uncovered six further challenges which are described below.

Next Steps for the TOCCC

The TOCCC focuses only on the transitions between the inpatient and outpatient settings and does not address the equally important transitions between many other different care settings, such as the transition from a hospital to a nursing home or rehabilitation facility. The intent of the TOCCC is to provide this document to national measure developers such as the Physician Consortium for Performance Improvement and others in order to guide measure development and ultimately lead to improvements in quality and safety in care transitions.

Studies of the transition of care between inpatient and outpatient settings have shown that there are significant patient safety and quality deficiencies in our current system. The transition from the hospital setting to the outpatient setting has been more extensively studied than the transition from the outpatient setting to the inpatient setting. One prospective cohort study of 400 patients found that 1 in 5 patients discharged from the hospital to home experienced an adverse event, which was defined as an injury resulting from medical management rather than the underlying disease, within 3 weeks of discharge.1 This study also concluded that 66% of these were drug‐related adverse events, many of which could have been avoided or mitigated. Another prospective cross‐sectional study of 2644 patient discharges found that approximately 40% of the patients had pending test results at the time of discharge and that 10% of these required some action, yet the outpatient physicians and patients were unaware of these results.2 Medication discrepancies have also been shown to be prevalent, with 1 prospective observational study of 375 patients showing that 14% of elderly patients had 1 or more medication discrepancies and 14% of those patients with medication discrepancies were rehospitalized within 30 days versus 6% of the patients who did not experience a medication discrepancy.3 A recent review of the literature cited improving transitional care as a key area of opportunity for improving postdischarge care4

Lack of communication has clearly been shown to adversely affect postdischarge care transitions.5 A recent summary of the literature by a Society of Hospital Medicine (SHM)/Society of General Internal Medicine (SGIM) task force found that direct communication between hospital physicians and primary care physicians occurs infrequently (in 3%‐20% of cases studied), and the availability of a discharge summary at the first postdischarge visit is low (12%‐34%) and does not improve greatly even after 4 weeks (51%‐77%); this affects the quality of care in approximately 25% of follow‐up visits.5 This systematic review of the literature also found that discharge summaries often lack important information such as diagnostic test results, the treatment or hospital course, discharge medications, test results pending at discharge, patient or family counseling, and follow‐up plans.

However, the lack of studies of the communication between ambulatory physicians and hospital physicians prior to admission or during emergency department (ED) visits does not imply that this communication is not equally important and essential to high‐quality care. According to the Centers for Disease Control, the greatest source of hospital admissions in many institutions is the ED. Over 115,000,000 visits were made to the nation's approximately 4828 EDs in 2005, and about 85.2% of ED visits end in discharge.6 The ED is also the point of re‐entry into the system for individuals who may have had an adverse outcome linked to a prior hospitalization.6 Communication between hospital physicians and primary care physicians must be established to create a loop of continuous care and diminish morbidity and mortality at this critical transition point.

While transitions can be a risky period for patient safety, observational studies suggest there are benefits to transitions. A new physician may notice something overlooked by the current caregivers.712 Another factor contributing to the challenges of care transitions is the lack of a single clinician or clinical entity taking responsibility for coordination across the continuum of the patient's overall healthcare, regardless of setting.13 Studies indicate that a relationship with a medical home is associated with better health on both the individual and population levels, with lower overall costs of care and with reductions in disparities in health between socially disadvantaged subpopulations and more socially advantaged populations.14 Several medical societies have addressed this issue, including the American College of Physicians (ACP), SGIM, American Academy of Family Physicians, and American Academy of Pediatrics, and they have proposed the concept of the medical home or patient‐centered medical home, which calls for clinicians to assume this responsibility for coordinating their patients' care across settings and for the healthcare system to value and reimburse clinicians for this patient‐centered and comprehensive method of practice.1517

Finally, patients and their families or caregivers have an important role to play in transitions of care. Several observational and cross‐sectional studies have shown that patients and their caregivers and families express significant feelings of anxiety during care transitions. This anxiety can be caused by a lack of understanding and preparation for their self‐care role in the next care setting, confusion due to conflicting advice from different practitioners, and a sense of abandonment attributable to the inability to contact an appropriate healthcare practitioner for guidance, and they report an overall disregard for their preferences and input into the design of the care plan.1820 Clearly, there is room for improvement in all these areas of the inpatient and outpatient care transition, and the Transitions of Care Consensus Conference (TOCCC) attempted to address these areas by developing standards for the transition of care that also harmonize with the work of the Stepping up to the Plate (SUTTP) Alliance of the American Board of Internal Medicine (ABIM) Foundation.21 In addition, other important stakeholders are addressing this topic and actively working to improve communication and continuity in care, including the Centers for Medicare and Medicaid Services (CMS) and the National Quality Forum (NQF). CMS recently developed the Continuity Assessment Record & Evaluation (CARE) tool, a data collection instrument designed to be a standardized, interoperable, common assessment tool to capture key patient characteristics that will provide information related to resource utilization, clinical outcomes, and postdischarge disposition. NQF held a national forum on care coordination in the spring of 2008.

In summary, it is clear that there are qualitative and quantitative deficiencies in transitions of care between the inpatient and outpatient setting that are affecting patient safety and experience with care. The transition from the inpatient setting to the outpatient setting has been more extensively studied, and this body of literature has underscored for the TOCCC several important areas in need of guidance and improvement. Because of this, the scope of application of this document should initially emphasize inpatient‐to‐outpatient transitions as a first step in learning how to improve these processes. However, the transition from the outpatient setting to the inpatient setting also is a clear priority. Because the needs for transfer of information, authority, and responsibility may be different in these situations, a second phase of additional work to develop principles to guide these transitions should be undertaken as quickly as possible. Experience gained in applying these principles to inpatient‐to‐outpatient transitions might usefully inform such work.

Communication among providers and with the patients and their families arose as a clear priority. Medication discrepancies, pending tests, and unknown diagnostic or treatment plans have an immediate impact on patients' health and outcomes. The TOCCC discussed what elements should be among the standard pieces of information exchanged among providers during these transition points. The dire need for coordination of care or a coordinating clinician/medical home became a clear theme in the deliberations of the TOCCC. Most importantly, the role of the patients and their families/caregivers in their continuing care is apparent, and the TOCCC felt this must be an integral part of any principles or standards for transitions of care.

Methods

In the fall/winter of 2006, the executive committees of ACP, SGIM, and SHM agreed to jointly develop a policy statement on transitions of care. Transitions of care specifically between the inpatient and outpatient settings were selected as an ideal topic for collaboration for the 3 societies as they represent the continuum of care for internal medicine within these settings. To accomplish this, the 3 organizations decided to convene a consensus conference to develop consensus guidelines and standards concerning transitions between inpatient and outpatient settings through a multi‐stakeholder process. A steering committee was convened with representatives from ACP, SGIM, SHM, the Agency for Healthcare Research and Quality (AHRQ), ABIM, and the American Geriatric Society (AGS). The steering committee developed the agenda and invitee list for the consensus conference. After the conference was held, the steering committee was expanded to include representation from the American College of Emergency Physicians (ACEP) and the Society for Academic Emergency Medicine (SAEM).

During the planning stages of the TOCCC, the steering committee became aware of the SUTTP Alliance of the ABIM Foundation. The SUTTP Alliance has representation from medical specialties such as internal medicine and its subspecialties, family medicine, and surgery. The alliance was formed in 2006 and has been working on care coordination across multiple settings and specialties. The SUTTP Alliance had developed a set of principles and standards for care transitions and agreed to provide the draft document to the TOCCC for review, input, and further development and refinement.

Recommendations on Principles and Standards for Managing Transitions in Care Between the Inpatient and Outpatient Settings from ACP, SGIM, SHM, AGS, ACEP, and SAEM

The SUTTP Alliance presented a draft document entitled Principles and Standards for Managing Transitions in Care. In this document, the SUTTP Alliance proposes 5 principles and 8 standards for effective care transitions. A key element of the conference was a presentation by NQF on how to move from principles to standards and eventually to measures. This presentation provided the TOCCC with the theoretical underpinnings for the discussion of these principles and standards and how the TOCCC would provide input on them. The presentation provided an outline for the flow from principles to measures. First, there needs to be a framework that provides guiding principles for what we would like to measure and eventually report. From those principles, a set of preferred practices or standards are developed; the standards are more granular and allow for more specificity in describing the desired practice or outcome and its elements. Standards then provide a roadmap for identification and development of performance measures. With this framework in mind, the TOCCC then discussed in detail the SUTTP principles and standards.

The 5 principles for effective care transitions developed by the SUTTP Alliance are as follows:

• Accountability.

• Communication: clear and direct communication of treatment plans and follow‐up expectations.

• Timely feedback and feed‐forward of information.

• Involvement of the patient and family member, unless inappropriate, in all steps.

• Respect of the hub of coordination of care.

The TOCCC re‐affirmed these principles and added 4 additional principles to this list. Three of the new principles were statements within the 8 standards developed by the SUTTP, but when taking into consideration the framework for the development of principles into standards, the TOCCC felt that the statements were better represented as principles. They are as follows:

• All patients and their families/caregivers should have and should be able to identify their medical home or coordinating clinician (ie, practice or practitioner). (This was originally part of the coordinating clinicians standard, and the TOCCC voted to elevate this to a principle).

• At every point along the transition, the patients and/or their families/caregivers need to know who is responsible for care at that point and who to contact and how.

• National standards should be established for transitions in care and should be adopted and implemented at the national and community level through public health institutions, national accreditation bodies, medical societies, medical institutions, and so forth in order to improve patient outcomes and patient safety. (This was originally part of the SUTTP community standards standard, and the TOCCC moved to elevate this to a principle).

• For monitoring and improving transitions, standardized metrics related to these standards should be used in order to lead to continuous quality improvement and accountability. (This was originally part of the measurement standard, and the TOCCC voted to elevate this to a principle).

The SUTTP Alliance proposed the following 8 standards for care transitions:

• Coordinating clinicians.

• Care plans.

• Communication infrastructure.

• Standard communication formats.

• Transition responsibility.

• Timeliness.

• Community standards.

• Measurement.

The TOCCC affirmed these standards and through a consensus process added more specificity to most of them and elevated components of some of them to principles, as discussed previously. The TOCCC proposes that the following be merged with the SUTTP standards:

• Coordinating clinicians. Communication and information exchange between the medical home and the receiving provider should occur in an amount of time that will allow the receiving provider to effectively treat the patient. This communication and information exchange should ideally occur whenever patients are at a transition of care (eg, at discharge from the inpatient setting). The timeliness of this communication should be consistent with the patient's clinical presentation and, in the case of a patient being discharged, the urgency of the follow‐up required. Guidelines will need to be developed that address both the timeliness and means of communication between the discharging physician and the medical home. Communication and information exchange between the medical home and other physicians may be in the form of a call, voice mail, fax, or other secure, private, and accessible means including mutual access to an electronic health record.

  The ED represents a unique subset of transitions of care. The potential transition can generally be described as outpatient to outpatient or outpatient to inpatient, depending on whether or not the patient is admitted to the hospital. The outpatient‐to‐outpatient transition can also encompass a number of potential variations. Patients with a medical home may be referred to the ED by the medical home, or they may self‐refer. A significant number of patients do not have a physician and self‐refer to the ED. The disposition from the ED, either outpatient to outpatient or outpatient to inpatient, is similarly represented by a number of variables. Discharged patients may or may not have a medical home, may or may not need a specialist, and may or may not require urgent (<24 hours) follow‐up. Admitted patients may or may not have a medical home and may or may not require specialty care. This variety of variables precludes a single approach to ED transition of care coordination. The determination of which scenarios will be appropriate for the development of standards (coordinating clinicians and transition responsibility) will require further contributions from ACEP and SAEM and review by the steering committee.

• Care plans/transition record. The TOCCC also agreed that there is a minimal set of data elements that should always be part of the transition record. The TOCCC suggested that this minimal data set be part of an initial implementation of this standard. That list includes the following:

  The TOCCC discussed what components should be included in an ideal transition record and agreed on the following elements:

  The TOCCC also added a new standard under this heading: Patients and/or their families/caregivers must receive, understand, and be encouraged to participate in the development of the transition record, which should take into consideration patients' health literacy and insurance status and be culturally sensitive.

• Principle diagnosis and problem list.

• Medication list (reconciliation) including over‐the‐counter medications/herbals, allergies, and drug interactions.

• Clear identification of the medical home/transferring coordinating physician/emnstitution and the contact information.

• Patient's cognitive status.

• Test results/pending results.

• Principle diagnosis and problem list.

• Medication list (reconciliation) including over‐the‐counter medications/herbals, allergies, and drug interactions.

• Emergency plan and contact number and person.

• Treatment and diagnostic plan.

• Prognosis and goals of care.

• Test results/pending results.

• Clear identification of the medical home and/or transferring coordinating physician/emnstitution.

• Patient's cognitive status.

• Advance directives, power of attorney, and consent.

• Planned interventions, durable medical equipment, wound care, and so forth.

• Assessment of caregiver status.

• Communication infrastructure. All communications between providers and between providers and patients and families/caregivers need to be secure, private, Health Insurance Portability and Accountability Actcompliant, and accessible to patients and those practitioners who care for them. Communication needs to be 2‐way with an opportunity for clarification and feedback. Each sending provider needs to provide a contact name and the number of an individual who can respond to questions or concerns. The content of transferred information needs to include a core standardized data set. This information needs to be transferred as a living database; that is, it is created only once, and then each subsequent provider only needs to update, validate, or modify the information. Patient information should be available to the provider prior to the patient's arrival. Information transfer needs to adhere to national data standards. Patients should be provided with a medication list that is accessible (paper or electronic), clear, and dated.

• Standard communication formats. Communities need to develop standard data transfer forms (templates and transmission protocols). Access to a patient's medical history needs to be on a current and ongoing basis with the ability to modify information as a patient's condition changes. Patients, families, and caregivers should have access to their information (nothing about me without me). A section on the transfer record should be devoted to communicating a patient's preferences, priorities, goals, and values (eg, the patient does not want intubation).

• Transition responsibility. The sending provider/emnstitution/team at the clinical organization maintains responsibility for the care of the patient until the receiving clinician/location confirms that the transfer and assumption of responsibility is complete (within a reasonable timeframe for the receiving clinician to receive the information; ie, transfers that occur in the middle of the night can be communicated during standard working hours). The sending provider should be available for clarification with issues of care within a reasonable timeframe after the transfer has been completed, and this timeframe should be based on the conditions of the transfer settings. The patient should be able to identify the responsible provider. In the case of patients who do not have an ongoing ambulatory care provider or whose ambulatory care provider has not assumed responsibility, the hospital‐based clinicians will not be required to assume responsibility for the care of these patients once they are discharged.

• Timeliness. Timeliness of feedback and feed‐forward of information from a sending provider to a receiving provider should be contingent on 4 factors:

  This information should be available at the time of the patient encounter.

• Transition settings.

• Patient circumstances.

• Level of acuity.

• Clear transition responsibility.

• Community standards. Medical communities/emnstitutions must demonstrate accountability for transitions of care by adopting national standards, and processes should be established to promote effective transitions of care.

• Measurement. For monitoring and improving transitions, standardized metrics related to these standards should be used. These metrics/measures should be evidence‐based, address documented gaps, and have a demonstrated impact on improving care (complying with performance measure standards) whenever feasible. Results from measurements using standardized metrics must lead to continuous improvement of the transition process. The validity, reliability, cost, and impact, including unintended consequences, of these measures should be assessed and re‐evaluated.

All these standards should be applied with special attention to the various transition settings and should be appropriate to each transition setting. Measure developers will need to take this into account when developing measures based on these proposed standards.

The TOCCC also went through a consensus prioritization exercise to rank‐order the consensus standards. All meeting participants were asked to rank their top 3 priorities of the 7 standards, giving a numeric score of 1 for their highest priority, a score of 2 for their second highest priority, and a score of 3 for their third highest priority. Summary scores were calculated, and the standards were rank‐ordered from the lowest summary score to the highest. The TOCCC recognizes that full implementation of all of these standards may not be feasible and that these standards may be implemented on a stepped or incremental basis. This prioritization can assist in deciding which of these to implement. The results of the prioritization exercise are as follows:

• 1

  All transitions must include a transition record

• 2

  Transition responsibility

• 3

  Coordinating clinicians

• 4

  Patient and family involvement and ownership of the transition record

• 5

  Communication infrastructure

• 6

  Timeliness

• 7

  Community standards

Future Challenges

In addition to the work on the principles and standards, the TOCCC uncovered six further challenges which are described below.

Next Steps for the TOCCC

The TOCCC focuses only on the transitions between the inpatient and outpatient settings and does not address the equally important transitions between many other different care settings, such as the transition from a hospital to a nursing home or rehabilitation facility. The intent of the TOCCC is to provide this document to national measure developers such as the Physician Consortium for Performance Improvement and others in order to guide measure development and ultimately lead to improvements in quality and safety in care transitions.

Adverse events occur to patients after their discharge from acute care hospitals.1, 2 Most of these injuries are adverse drug events, procedure‐related events, nosocomial infections, or falls.1 Postdischarge adverse events are associated with several days of symptoms, nonpermanent disability, emergency department visits, or hospital readmission.1, 3 When adverse events are preventable or ameliorable, the most common root cause is poor communication between hospital personnel and either the patient or the outpatient primary care physician.1 In addition, there may be deficits in discharge processes related to assessment and communication of unresolved problems.1 Systematic reviews have shown that discharge communication is an inefficient and error‐prone process.46

One potential solution to poor discharge communication is health information technology.7 An example of technology is discharge software with a computerized physician order entry (CPOE) system. By definition, a CPOE system is a computer‐based system that automates direct entry of orders by physicians and ensures standardized, legible, and complete orders.8 The benefits of CPOE have been tested in other inpatient settings.8, 9 It is logical to consider software applications with CPOE for discharge interventions.7

Several mechanisms explain the potential benefit of discharge software with CPOE.7 Applications with CPOE decrease medication errors.8, 10 Software with decision support could prompt physicians to enter posthospitalization appointment dates and orders for preventive services.11, 12 Discharge software could facilitate medication reconciliation and generate patient instructions and information.4, 1315 The potential benefits of discharge software with CPOE provide a rationale for clinical trials to measure benefits.

Previous studies addressed discharge applications of health information technology. Observational studies recorded outcomes such as physician satisfaction.16, 17 Prior randomized clinical trials measured quality and timeliness of discharge summaries.18 However, these previous trials did not assess clinically relevant outcomes like readmissions, emergency department visits, or adverse events. We performed a cluster‐randomized trial to assess the value of a discharge software application of CPOE. The rationale for our clustered design complied with recommendations from a systematic review of discharge interventions.5 Our objective was to assess the benefit of discharge software with CPOE when used to discharge patients at high risk for repeat admission. After the intervention, we compared the rates of hospital readmission, emergency department visits, and postdischarge adverse events due to medical management.

Methods

The trial design was a cluster randomized, controlled trial with blinded outcome assessment. Follow‐up occurred until 6 months after discharge from index hospitalization at a 730‐bed, tertiary care, teaching hospital in central Illinois. The Peoria Institutional Review Board approved the protocol for human research.

Results

We screened 127 physicians who were general internal medicine hospital physicians. Seventy physicians consented and received random allocation to discharge software or usual care. The physician characteristics appear in Table 1. Most of the hospital physicians were interns in the first year of postgraduate training (58.6%; 41/70). We excluded 57 physicians for reasons shown in the trial flow diagram (Figure 1). The most common reason for hospital physician exclusion applied to resident physicians in their last months of training before graduation or emergency department residents temporarily assigned to internal medicine training. We approached 6,884 patients during their index hospitalization. After excluding 6,253 ineligible patients, we enrolled and followed 631 patients who received the discharge intervention (Figure 1). During 6 months of follow‐up, a small proportion of patients died (3%; 20/631). Hospital records were available for deceased patients and they were included in the analysis. A small proportion (6%; 41/631) of patients withdrew consent or left the trial for other reasons during 6 months. There was no differential dropout between the interventions. Protocol deviations were rare (0.5%; 3/631). Three patients erroneously received usual care discharge from physicians assigned to discharge software. All 631 patients were included in the intention‐to‐treat analysis. The baseline characteristics of the randomly‐assigned hospital physicians and their patients are in Table 1.

Figure 1

We asked outpatient physicians about their receipt of discharge communication from hospital physicians. The text of the question was, How soon after discharge did you receive any information (in any form) relating to this patient's hospital admission and discharge plans? We mailed the question 10 days after discharge to outpatient physicians designated by patients enrolled in the study. Among patients in the discharge software group, 75.0% (237/316) of their outpatient physicians responded to the question. The response rate was 80.6% (254/315) from physicians who followed patients in the usual care group. Respondents from the discharge software group said within 1‐2 days or within a week for 56.0% (177/316) of patients. Respondents from the usual care group said within 1‐2 days or within a week for 57.1% (180/315) of patients. The difference between the intervention groups, 1.1% (95% CI, 9.2% to 6.9%), was not significant.

The primary, prespecified, outcome of the study was the proportion of patients with at least 1 readmission to the hospital. After intervention with discharge software versus usual care, there was no significant difference in readmission rates (Table 2) or time to first readmission (Figure 2). We screened all baseline variables in Table 1 and sought predictors of readmission to employ in adjusted models. For example, we evaluated physician level of training because we wondered if experience or seniority affected readmission when hospital physicians used the discharge software or usual care discharge. The candidate variable, physician level of training, did not correlate with readmission (rho = 0.066; P = 0.100), so it was dropped from subsequent analyses. After screening all variables in Table 1, we found 4 independent predictors of readmission: previous hospitalizations, previous emergency department visits, heart failure, and physical function. Generalized estimating equations for readmission that adjusted for predictor variables confirmed a negligible parameter estimate for the discharge intervention variable coefficient (Table 2).

Figure 2

We evaluated emergency department visits that were unrelated to readmission as secondary, prespecified, outcomes. The results were similar to readmission results. While the proportion of patients with at least 1 emergency department visit was lower for the discharge software intervention, the difference with usual care was not significant (Table 2). There was no significant difference between interventions for time to first emergency department visit (Figure 3).

Figure 3

Postdischarge adverse events were secondary, prespecified, outcomes. Data for adverse event adjudication were available for 98% (309/316) of discharge software patients and 97% (307/315) of usual care patients. Within 1 month after discharge, 46 patients had adverse events probably or definitely related to medical management. Two patients had 2 events and 1 patient had 3 events. For analysis, we randomly selected 1 event per patient. When comparing patients assigned to discharge software versus usual care, there were no differences in adverse events related to medical management (Table 2). Most of the events were possible adverse drug events (74%; 34/46). The adverse event severity was several days of symptoms or nonpermanent disability for 76% (35/46) of the adverse events. Adjudicators rated 26% (12/46) of the adverse events as preventable and 46% (21/46) as ameliorable. The absolute numbers of events were small. There were no differences between discharge software and usual care patients within adverse event strata defined by type, severity, preventable, or ameliorable (Table 3). For most of the patients with adverse events, the adjudicators could not identify a system problem or preventability category (Table 3). When a deficiency was evident, there was no pattern to suggest a significant difference between discharge software patients versus usual care patients.

When we designed the trial, we assumed variance in outcomes measured at the patient level. We predicted some variance attributable to clustering by hospital physician. After the trial, we calculated the intracluster correlation coefficients for readmissions, emergency department visits, and adverse events. For all of these outcomes, the intracluster correlation coefficients were negligible. We also evaluated generalized estimating equations with and without correction for hospital physician cluster. We confirmed the negligible cluster effect on confidence intervals for intervention coefficients (Table 2).

We performed an exploratory stratified analysis. We evaluated the intervention effect on readmission within subgroups defined by covariates that predicted readmission (Table 4). When the intervention groups were compared within baseline categories of previous hospitalizations, previous emergency department visits, heart failure, and physical functioning, there was a consistent pattern with no differential effect by intervention assignment. None of the intervention coefficients were statistically significant (Table 4).

Discussion

We performed a cluster‐randomized clinical trial to measure the effects of discharge software versus usual care handwritten discharge. The discharge software with CPOE implemented elements of high‐quality discharge planning and communication endorsed by the National Quality Forum and systematic reviews.6, 38 Despite theoretical benefits, our discharge software intervention did not reduce readmissions or emergency department visits. What were potential explanations for our results? We assumed an association between postdischarge adverse events and readmissions or emergency department visits.1 Our failure to reduce adverse events might explain the failure to reduce readmissions or emergency department visits. Another potential explanation was related to adverse drug events. Other investigators showed most postdischarge adverse events were adverse drug events and our data confirmed previous studies.1, 2 Medication reconciliation at discharge was a potential mechanism for adverse drug event reduction.14 Medication reconciliation was the standard at the study hospital, so it was unethical to deny reconciliation to patients assigned to either intervention.39 Required medication reconciliation in both groups, by its known effect on preventable adverse drug events, might have reduced the event rates in both groups.14 This possibility is supported by the low rate of adverse events observed in our study compared with other studies.1 We speculate that the low background rate of adverse events at the study hospital may have minimized events in both the discharge software and usual care groups and prevented detection of software benefits, if present.39

One limitation of our study may have been the discharge software. The automated decision support in our software lacked features that might have improved outcomes. For example, the software did not generate a list of diagnostic test results that were pending at the time of discharge. Our software relied on prompts to the physician user that did not specify which tests were pending. The software did not perform error checks on the discharge orders to warn physicians about drug‐drug interactions, therapeutic duplications, or missing items (eg, immunizations, drugs, education). The absence of these software enhancements made our discharge process vulnerable to the lapses and slips of the physician user. Whether or not such enhancements affect clinically relevant outcomes remains a testable hypothesis for future studies.

Another limitation of our study was the outpatient physician response. Discharge software did not increase the proportion of outpatient physicians who said they received communication within 7 days after hospital discharge. Our intervention addressed the sending partner but not the receiving partner in the communication dyad. Our discharge software was not designed to change information flow within the outpatient physician office. We do not know if discharge communication arrived and remained unnoticed until the patient called or visited the outpatient clinic. Future studies of discharge communication should consider a closed loop design to assure receipt and comprehension.

When we designed our study, we expected at least some variance between patient clusters attributable to the physician who performed the discharge. Our analysis of intracluster correlation revealed negligible variance. We speculate the highly‐standardized discharge process implemented by discharge software and usual care at our hospital resulted in minimal variance. Future studies of discharge interventions may consider designs that avoid cluster randomization.

In conclusion, a discharge software application of CPOE did not affect readmissions, emergency department visits, or adverse events after discharge.

Adverse events occur to patients after their discharge from acute care hospitals.1, 2 Most of these injuries are adverse drug events, procedure‐related events, nosocomial infections, or falls.1 Postdischarge adverse events are associated with several days of symptoms, nonpermanent disability, emergency department visits, or hospital readmission.1, 3 When adverse events are preventable or ameliorable, the most common root cause is poor communication between hospital personnel and either the patient or the outpatient primary care physician.1 In addition, there may be deficits in discharge processes related to assessment and communication of unresolved problems.1 Systematic reviews have shown that discharge communication is an inefficient and error‐prone process.46

One potential solution to poor discharge communication is health information technology.7 An example of technology is discharge software with a computerized physician order entry (CPOE) system. By definition, a CPOE system is a computer‐based system that automates direct entry of orders by physicians and ensures standardized, legible, and complete orders.8 The benefits of CPOE have been tested in other inpatient settings.8, 9 It is logical to consider software applications with CPOE for discharge interventions.7

Several mechanisms explain the potential benefit of discharge software with CPOE.7 Applications with CPOE decrease medication errors.8, 10 Software with decision support could prompt physicians to enter posthospitalization appointment dates and orders for preventive services.11, 12 Discharge software could facilitate medication reconciliation and generate patient instructions and information.4, 1315 The potential benefits of discharge software with CPOE provide a rationale for clinical trials to measure benefits.

Previous studies addressed discharge applications of health information technology. Observational studies recorded outcomes such as physician satisfaction.16, 17 Prior randomized clinical trials measured quality and timeliness of discharge summaries.18 However, these previous trials did not assess clinically relevant outcomes like readmissions, emergency department visits, or adverse events. We performed a cluster‐randomized trial to assess the value of a discharge software application of CPOE. The rationale for our clustered design complied with recommendations from a systematic review of discharge interventions.5 Our objective was to assess the benefit of discharge software with CPOE when used to discharge patients at high risk for repeat admission. After the intervention, we compared the rates of hospital readmission, emergency department visits, and postdischarge adverse events due to medical management.

Methods

The trial design was a cluster randomized, controlled trial with blinded outcome assessment. Follow‐up occurred until 6 months after discharge from index hospitalization at a 730‐bed, tertiary care, teaching hospital in central Illinois. The Peoria Institutional Review Board approved the protocol for human research.

Results

We screened 127 physicians who were general internal medicine hospital physicians. Seventy physicians consented and received random allocation to discharge software or usual care. The physician characteristics appear in Table 1. Most of the hospital physicians were interns in the first year of postgraduate training (58.6%; 41/70). We excluded 57 physicians for reasons shown in the trial flow diagram (Figure 1). The most common reason for hospital physician exclusion applied to resident physicians in their last months of training before graduation or emergency department residents temporarily assigned to internal medicine training. We approached 6,884 patients during their index hospitalization. After excluding 6,253 ineligible patients, we enrolled and followed 631 patients who received the discharge intervention (Figure 1). During 6 months of follow‐up, a small proportion of patients died (3%; 20/631). Hospital records were available for deceased patients and they were included in the analysis. A small proportion (6%; 41/631) of patients withdrew consent or left the trial for other reasons during 6 months. There was no differential dropout between the interventions. Protocol deviations were rare (0.5%; 3/631). Three patients erroneously received usual care discharge from physicians assigned to discharge software. All 631 patients were included in the intention‐to‐treat analysis. The baseline characteristics of the randomly‐assigned hospital physicians and their patients are in Table 1.

Figure 1

We asked outpatient physicians about their receipt of discharge communication from hospital physicians. The text of the question was, How soon after discharge did you receive any information (in any form) relating to this patient's hospital admission and discharge plans? We mailed the question 10 days after discharge to outpatient physicians designated by patients enrolled in the study. Among patients in the discharge software group, 75.0% (237/316) of their outpatient physicians responded to the question. The response rate was 80.6% (254/315) from physicians who followed patients in the usual care group. Respondents from the discharge software group said within 1‐2 days or within a week for 56.0% (177/316) of patients. Respondents from the usual care group said within 1‐2 days or within a week for 57.1% (180/315) of patients. The difference between the intervention groups, 1.1% (95% CI, 9.2% to 6.9%), was not significant.

The primary, prespecified, outcome of the study was the proportion of patients with at least 1 readmission to the hospital. After intervention with discharge software versus usual care, there was no significant difference in readmission rates (Table 2) or time to first readmission (Figure 2). We screened all baseline variables in Table 1 and sought predictors of readmission to employ in adjusted models. For example, we evaluated physician level of training because we wondered if experience or seniority affected readmission when hospital physicians used the discharge software or usual care discharge. The candidate variable, physician level of training, did not correlate with readmission (rho = 0.066; P = 0.100), so it was dropped from subsequent analyses. After screening all variables in Table 1, we found 4 independent predictors of readmission: previous hospitalizations, previous emergency department visits, heart failure, and physical function. Generalized estimating equations for readmission that adjusted for predictor variables confirmed a negligible parameter estimate for the discharge intervention variable coefficient (Table 2).

Figure 2

We evaluated emergency department visits that were unrelated to readmission as secondary, prespecified, outcomes. The results were similar to readmission results. While the proportion of patients with at least 1 emergency department visit was lower for the discharge software intervention, the difference with usual care was not significant (Table 2). There was no significant difference between interventions for time to first emergency department visit (Figure 3).

Figure 3

Postdischarge adverse events were secondary, prespecified, outcomes. Data for adverse event adjudication were available for 98% (309/316) of discharge software patients and 97% (307/315) of usual care patients. Within 1 month after discharge, 46 patients had adverse events probably or definitely related to medical management. Two patients had 2 events and 1 patient had 3 events. For analysis, we randomly selected 1 event per patient. When comparing patients assigned to discharge software versus usual care, there were no differences in adverse events related to medical management (Table 2). Most of the events were possible adverse drug events (74%; 34/46). The adverse event severity was several days of symptoms or nonpermanent disability for 76% (35/46) of the adverse events. Adjudicators rated 26% (12/46) of the adverse events as preventable and 46% (21/46) as ameliorable. The absolute numbers of events were small. There were no differences between discharge software and usual care patients within adverse event strata defined by type, severity, preventable, or ameliorable (Table 3). For most of the patients with adverse events, the adjudicators could not identify a system problem or preventability category (Table 3). When a deficiency was evident, there was no pattern to suggest a significant difference between discharge software patients versus usual care patients.

When we designed the trial, we assumed variance in outcomes measured at the patient level. We predicted some variance attributable to clustering by hospital physician. After the trial, we calculated the intracluster correlation coefficients for readmissions, emergency department visits, and adverse events. For all of these outcomes, the intracluster correlation coefficients were negligible. We also evaluated generalized estimating equations with and without correction for hospital physician cluster. We confirmed the negligible cluster effect on confidence intervals for intervention coefficients (Table 2).

We performed an exploratory stratified analysis. We evaluated the intervention effect on readmission within subgroups defined by covariates that predicted readmission (Table 4). When the intervention groups were compared within baseline categories of previous hospitalizations, previous emergency department visits, heart failure, and physical functioning, there was a consistent pattern with no differential effect by intervention assignment. None of the intervention coefficients were statistically significant (Table 4).

Discussion

We performed a cluster‐randomized clinical trial to measure the effects of discharge software versus usual care handwritten discharge. The discharge software with CPOE implemented elements of high‐quality discharge planning and communication endorsed by the National Quality Forum and systematic reviews.6, 38 Despite theoretical benefits, our discharge software intervention did not reduce readmissions or emergency department visits. What were potential explanations for our results? We assumed an association between postdischarge adverse events and readmissions or emergency department visits.1 Our failure to reduce adverse events might explain the failure to reduce readmissions or emergency department visits. Another potential explanation was related to adverse drug events. Other investigators showed most postdischarge adverse events were adverse drug events and our data confirmed previous studies.1, 2 Medication reconciliation at discharge was a potential mechanism for adverse drug event reduction.14 Medication reconciliation was the standard at the study hospital, so it was unethical to deny reconciliation to patients assigned to either intervention.39 Required medication reconciliation in both groups, by its known effect on preventable adverse drug events, might have reduced the event rates in both groups.14 This possibility is supported by the low rate of adverse events observed in our study compared with other studies.1 We speculate that the low background rate of adverse events at the study hospital may have minimized events in both the discharge software and usual care groups and prevented detection of software benefits, if present.39

One limitation of our study may have been the discharge software. The automated decision support in our software lacked features that might have improved outcomes. For example, the software did not generate a list of diagnostic test results that were pending at the time of discharge. Our software relied on prompts to the physician user that did not specify which tests were pending. The software did not perform error checks on the discharge orders to warn physicians about drug‐drug interactions, therapeutic duplications, or missing items (eg, immunizations, drugs, education). The absence of these software enhancements made our discharge process vulnerable to the lapses and slips of the physician user. Whether or not such enhancements affect clinically relevant outcomes remains a testable hypothesis for future studies.

Another limitation of our study was the outpatient physician response. Discharge software did not increase the proportion of outpatient physicians who said they received communication within 7 days after hospital discharge. Our intervention addressed the sending partner but not the receiving partner in the communication dyad. Our discharge software was not designed to change information flow within the outpatient physician office. We do not know if discharge communication arrived and remained unnoticed until the patient called or visited the outpatient clinic. Future studies of discharge communication should consider a closed loop design to assure receipt and comprehension.

When we designed our study, we expected at least some variance between patient clusters attributable to the physician who performed the discharge. Our analysis of intracluster correlation revealed negligible variance. We speculate the highly‐standardized discharge process implemented by discharge software and usual care at our hospital resulted in minimal variance. Future studies of discharge interventions may consider designs that avoid cluster randomization.

In conclusion, a discharge software application of CPOE did not affect readmissions, emergency department visits, or adverse events after discharge.

Adverse events occur to patients after their discharge from acute care hospitals.1, 2 Most of these injuries are adverse drug events, procedure‐related events, nosocomial infections, or falls.1 Postdischarge adverse events are associated with several days of symptoms, nonpermanent disability, emergency department visits, or hospital readmission.1, 3 When adverse events are preventable or ameliorable, the most common root cause is poor communication between hospital personnel and either the patient or the outpatient primary care physician.1 In addition, there may be deficits in discharge processes related to assessment and communication of unresolved problems.1 Systematic reviews have shown that discharge communication is an inefficient and error‐prone process.46

One potential solution to poor discharge communication is health information technology.7 An example of technology is discharge software with a computerized physician order entry (CPOE) system. By definition, a CPOE system is a computer‐based system that automates direct entry of orders by physicians and ensures standardized, legible, and complete orders.8 The benefits of CPOE have been tested in other inpatient settings.8, 9 It is logical to consider software applications with CPOE for discharge interventions.7

Several mechanisms explain the potential benefit of discharge software with CPOE.7 Applications with CPOE decrease medication errors.8, 10 Software with decision support could prompt physicians to enter posthospitalization appointment dates and orders for preventive services.11, 12 Discharge software could facilitate medication reconciliation and generate patient instructions and information.4, 1315 The potential benefits of discharge software with CPOE provide a rationale for clinical trials to measure benefits.

Previous studies addressed discharge applications of health information technology. Observational studies recorded outcomes such as physician satisfaction.16, 17 Prior randomized clinical trials measured quality and timeliness of discharge summaries.18 However, these previous trials did not assess clinically relevant outcomes like readmissions, emergency department visits, or adverse events. We performed a cluster‐randomized trial to assess the value of a discharge software application of CPOE. The rationale for our clustered design complied with recommendations from a systematic review of discharge interventions.5 Our objective was to assess the benefit of discharge software with CPOE when used to discharge patients at high risk for repeat admission. After the intervention, we compared the rates of hospital readmission, emergency department visits, and postdischarge adverse events due to medical management.

Methods

The trial design was a cluster randomized, controlled trial with blinded outcome assessment. Follow‐up occurred until 6 months after discharge from index hospitalization at a 730‐bed, tertiary care, teaching hospital in central Illinois. The Peoria Institutional Review Board approved the protocol for human research.

Results

We screened 127 physicians who were general internal medicine hospital physicians. Seventy physicians consented and received random allocation to discharge software or usual care. The physician characteristics appear in Table 1. Most of the hospital physicians were interns in the first year of postgraduate training (58.6%; 41/70). We excluded 57 physicians for reasons shown in the trial flow diagram (Figure 1). The most common reason for hospital physician exclusion applied to resident physicians in their last months of training before graduation or emergency department residents temporarily assigned to internal medicine training. We approached 6,884 patients during their index hospitalization. After excluding 6,253 ineligible patients, we enrolled and followed 631 patients who received the discharge intervention (Figure 1). During 6 months of follow‐up, a small proportion of patients died (3%; 20/631). Hospital records were available for deceased patients and they were included in the analysis. A small proportion (6%; 41/631) of patients withdrew consent or left the trial for other reasons during 6 months. There was no differential dropout between the interventions. Protocol deviations were rare (0.5%; 3/631). Three patients erroneously received usual care discharge from physicians assigned to discharge software. All 631 patients were included in the intention‐to‐treat analysis. The baseline characteristics of the randomly‐assigned hospital physicians and their patients are in Table 1.

Figure 1

We asked outpatient physicians about their receipt of discharge communication from hospital physicians. The text of the question was, How soon after discharge did you receive any information (in any form) relating to this patient's hospital admission and discharge plans? We mailed the question 10 days after discharge to outpatient physicians designated by patients enrolled in the study. Among patients in the discharge software group, 75.0% (237/316) of their outpatient physicians responded to the question. The response rate was 80.6% (254/315) from physicians who followed patients in the usual care group. Respondents from the discharge software group said within 1‐2 days or within a week for 56.0% (177/316) of patients. Respondents from the usual care group said within 1‐2 days or within a week for 57.1% (180/315) of patients. The difference between the intervention groups, 1.1% (95% CI, 9.2% to 6.9%), was not significant.

The primary, prespecified, outcome of the study was the proportion of patients with at least 1 readmission to the hospital. After intervention with discharge software versus usual care, there was no significant difference in readmission rates (Table 2) or time to first readmission (Figure 2). We screened all baseline variables in Table 1 and sought predictors of readmission to employ in adjusted models. For example, we evaluated physician level of training because we wondered if experience or seniority affected readmission when hospital physicians used the discharge software or usual care discharge. The candidate variable, physician level of training, did not correlate with readmission (rho = 0.066; P = 0.100), so it was dropped from subsequent analyses. After screening all variables in Table 1, we found 4 independent predictors of readmission: previous hospitalizations, previous emergency department visits, heart failure, and physical function. Generalized estimating equations for readmission that adjusted for predictor variables confirmed a negligible parameter estimate for the discharge intervention variable coefficient (Table 2).

Figure 2

We evaluated emergency department visits that were unrelated to readmission as secondary, prespecified, outcomes. The results were similar to readmission results. While the proportion of patients with at least 1 emergency department visit was lower for the discharge software intervention, the difference with usual care was not significant (Table 2). There was no significant difference between interventions for time to first emergency department visit (Figure 3).

Figure 3

Postdischarge adverse events were secondary, prespecified, outcomes. Data for adverse event adjudication were available for 98% (309/316) of discharge software patients and 97% (307/315) of usual care patients. Within 1 month after discharge, 46 patients had adverse events probably or definitely related to medical management. Two patients had 2 events and 1 patient had 3 events. For analysis, we randomly selected 1 event per patient. When comparing patients assigned to discharge software versus usual care, there were no differences in adverse events related to medical management (Table 2). Most of the events were possible adverse drug events (74%; 34/46). The adverse event severity was several days of symptoms or nonpermanent disability for 76% (35/46) of the adverse events. Adjudicators rated 26% (12/46) of the adverse events as preventable and 46% (21/46) as ameliorable. The absolute numbers of events were small. There were no differences between discharge software and usual care patients within adverse event strata defined by type, severity, preventable, or ameliorable (Table 3). For most of the patients with adverse events, the adjudicators could not identify a system problem or preventability category (Table 3). When a deficiency was evident, there was no pattern to suggest a significant difference between discharge software patients versus usual care patients.

When we designed the trial, we assumed variance in outcomes measured at the patient level. We predicted some variance attributable to clustering by hospital physician. After the trial, we calculated the intracluster correlation coefficients for readmissions, emergency department visits, and adverse events. For all of these outcomes, the intracluster correlation coefficients were negligible. We also evaluated generalized estimating equations with and without correction for hospital physician cluster. We confirmed the negligible cluster effect on confidence intervals for intervention coefficients (Table 2).

We performed an exploratory stratified analysis. We evaluated the intervention effect on readmission within subgroups defined by covariates that predicted readmission (Table 4). When the intervention groups were compared within baseline categories of previous hospitalizations, previous emergency department visits, heart failure, and physical functioning, there was a consistent pattern with no differential effect by intervention assignment. None of the intervention coefficients were statistically significant (Table 4).

Discussion

We performed a cluster‐randomized clinical trial to measure the effects of discharge software versus usual care handwritten discharge. The discharge software with CPOE implemented elements of high‐quality discharge planning and communication endorsed by the National Quality Forum and systematic reviews.6, 38 Despite theoretical benefits, our discharge software intervention did not reduce readmissions or emergency department visits. What were potential explanations for our results? We assumed an association between postdischarge adverse events and readmissions or emergency department visits.1 Our failure to reduce adverse events might explain the failure to reduce readmissions or emergency department visits. Another potential explanation was related to adverse drug events. Other investigators showed most postdischarge adverse events were adverse drug events and our data confirmed previous studies.1, 2 Medication reconciliation at discharge was a potential mechanism for adverse drug event reduction.14 Medication reconciliation was the standard at the study hospital, so it was unethical to deny reconciliation to patients assigned to either intervention.39 Required medication reconciliation in both groups, by its known effect on preventable adverse drug events, might have reduced the event rates in both groups.14 This possibility is supported by the low rate of adverse events observed in our study compared with other studies.1 We speculate that the low background rate of adverse events at the study hospital may have minimized events in both the discharge software and usual care groups and prevented detection of software benefits, if present.39

One limitation of our study may have been the discharge software. The automated decision support in our software lacked features that might have improved outcomes. For example, the software did not generate a list of diagnostic test results that were pending at the time of discharge. Our software relied on prompts to the physician user that did not specify which tests were pending. The software did not perform error checks on the discharge orders to warn physicians about drug‐drug interactions, therapeutic duplications, or missing items (eg, immunizations, drugs, education). The absence of these software enhancements made our discharge process vulnerable to the lapses and slips of the physician user. Whether or not such enhancements affect clinically relevant outcomes remains a testable hypothesis for future studies.

Another limitation of our study was the outpatient physician response. Discharge software did not increase the proportion of outpatient physicians who said they received communication within 7 days after hospital discharge. Our intervention addressed the sending partner but not the receiving partner in the communication dyad. Our discharge software was not designed to change information flow within the outpatient physician office. We do not know if discharge communication arrived and remained unnoticed until the patient called or visited the outpatient clinic. Future studies of discharge communication should consider a closed loop design to assure receipt and comprehension.

When we designed our study, we expected at least some variance between patient clusters attributable to the physician who performed the discharge. Our analysis of intracluster correlation revealed negligible variance. We speculate the highly‐standardized discharge process implemented by discharge software and usual care at our hospital resulted in minimal variance. Future studies of discharge interventions may consider designs that avoid cluster randomization.

In conclusion, a discharge software application of CPOE did not affect readmissions, emergency department visits, or adverse events after discharge.