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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Massachusetts General Hospital | OTHER |
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The objective of this study is to design and implement a set of procedures (the intervention) to improve patients' experiences when they are discharged home from the hospital. Second, this study aims to look at how the intervention affects problems that are known to occur after discharge, including medication issues, worsening medical problems, or readmission to the hospital. The investigators will study how well patients recover the ability to do the things they could before they were admitted to the hospital and their opinions of the discharge process. Lastly, this study will look to understand the best way to implement the intervention into different hospitals and practices, and which types of patients benefit from it most.
The specific aims of this study are:
To develop, implement, and refine a multi-faceted, multi-disciplinary transitions intervention with contributions from hospital and Patient-Centered Medical Home (PCMH) personnel.
Hypothesis: a collaborative transitions intervention can be designed and implemented within an ACO that reliably provides the components of an ideal transition in care.
To evaluate the effects of this intervention on post-discharge adverse events, functional status, patient engagement, and emergency department and hospital utilization within 30 days of discharge.
Hypothesis: compared with usual care, a collaborative transitions intervention will decrease post discharge adverse events, improve post-discharge functional status, increase patient engagement, and reduce emergency department and hospital utilization in the post-discharge period.
To understand barriers to and facilitators of successful implementation of this intervention across practices.
Hypothesis: several barriers to and facilitators of implementation can be identified and used to create lessons learned for other health systems to successfully implement this type of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-Model Intensive Discharge Program | Experimental | Multi-Model Intensive Discharge Program |
|
| Usual Care | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Model Intensive Discharge Intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date | Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date | 30 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge | New or worsening signs or symptoms, i.e. unpleasant symptoms, loss of function, abnormal lab results, and/or additional medical care within 30 days after discharge. | 30 days after discharge |
| Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date |
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Inclusion Criteria:
Potential subjects will be adult patients admitted to medical and surgical services at BWH and MGH, likely to be discharged back to the community, and whose PCP belongs to one of the Partners Community Healthcare, Inc. (PCHI) primary care practices that has met "Primed" criteria for being a PCMH, admits at least 2 patients to BWH or MGH, and has agreed to participate. Primed criteria are a standard set of requirements that cover 6 essential building blocks of PCMH practices: electronic health record, patient portal, team-based care, practice redesign, care management, and identification of high-risk patients. We estimate that of the approximately 300 PCHI adult primary care practices, 150 of them will meet PCMH criteria during the study and that 20 of them will qualify and be willing to participate in the study. We estimate that 12,000 such patients will be admitted to BWH and MGH over the 18-month study period, of which we will enroll 1700 patients. These patients are broadly representative of hospitalized patients and include several vulnerable populations, including the elderly (33% 65 or older), patients with multiple chronic conditions (47% with Elixhauser comorbidity score 5 or more), and racial and ethnic minorities (14% African American, 13% Latino).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Schnipper, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
Voluntarily participating in PCORI's Open Science Pilot
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A total of 141 eligible participants were enrolled to 1 pilot practice at Brigham and Women's Hospital and 1 pilot practice at Massachusetts General Hospital. These participants received the study Intervention so that we could troubleshoot and refine the Intervention procedures. These participants are NOT counted in the final enrollment number.
BWH participants were enrolled from 8/21/2013 to 5/15/2015. MGH participants were enrolled from 9/18/2013 to 10/13/2015. Participants were recruited while they were inpatients on the medical or surgical services at either BWH or MGH.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi-Model Intensive Discharge Program | Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:
|
| FG001 | Usual Care | Patients receive the care that they would normally receive. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multi-Model Intensive Discharge Program | Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date | Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date | 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission). | Posted | Number | 95% Confidence Interval | proportion of participants | 30 days after discharge |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multi-Model Intensive Discharge Program | Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey L Schnipper, MD, MPH, FHM | Brigham and Women's Hospital | 617-732-7063 | jschnipper@partners.org |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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This is a stepped-wedge design, where each primary care practice starts in usual care, and then at a randomly selected point in time switches to the intervention arm.
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Nonelective readmission within 30 days of the index discharge date |
| 30 days after discharge |
| Change in Functional Status on the Modified Medical Outcomes Survey Short Form-12 (SF-12v2) From One Month Prior to Admission to 30 Days After Discharge. | During the inpatient enrollment period, patients will complete a modified Medical Outcomes Survey Short Form-12 (SF-12v2). The SF-12v2 measures a patient's functional status and health-related quality of life one month prior to admission. 30 days after discharge, SF12 questions will be repeated so that functional status and health-related quality of life can be compared to prior to admission. This measure is a 12-item measure. Each item 5 possible responses with a value from 1 to 5 (with higher scores indicating worse outcomes). A summary score is computed by summing the score on each item. Therefore, the range of summary scores for the SF-12v2 is a minimum of 12 and a maximum of 60. | One month prior to admission to 30 days after discharge. |
| Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process | During the 30 day post-discharge follow-up phone call we asked patients about their participation in, understanding of, and ability to carry out the post-discharge plan. These questions include questions from the Interpersonal Processes of Care survey and several additional questions from the HOMERUN study of readmitted patients. In the table below, we have abbreviated each survey question since the number of characters is limited in this field in the table. We have pasted below the full survey question.
| 30 days after discharge |
| Post-Discharge Health Care Utilization | We will measure emergency department visits and hospital readmissions within 30 days of discharge using a combination of administrative data for all Partners hospitals plus patient report for all utilization outside the Partners system. | 30 days after discharge |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Part of practice that discontinued study |
|
| BG001 | Usual Care | Patients receive the same care they would normally receive. |
| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Usual Care | Patients receive the care they would normally receive. |
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| Secondary | Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge | New or worsening signs or symptoms, i.e. unpleasant symptoms, loss of function, abnormal lab results, and/or additional medical care within 30 days after discharge. | 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission). | Posted | Number | 95% Confidence Interval | proportion of participants | 30 days after discharge |
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| Secondary | Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date | Nonelective readmission within 30 days of the index discharge date | 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission). | Posted | Number | participants | 30 days after discharge |
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| Secondary | Change in Functional Status on the Modified Medical Outcomes Survey Short Form-12 (SF-12v2) From One Month Prior to Admission to 30 Days After Discharge. | During the inpatient enrollment period, patients will complete a modified Medical Outcomes Survey Short Form-12 (SF-12v2). The SF-12v2 measures a patient's functional status and health-related quality of life one month prior to admission. 30 days after discharge, SF12 questions will be repeated so that functional status and health-related quality of life can be compared to prior to admission. This measure is a 12-item measure. Each item 5 possible responses with a value from 1 to 5 (with higher scores indicating worse outcomes). A summary score is computed by summing the score on each item. Therefore, the range of summary scores for the SF-12v2 is a minimum of 12 and a maximum of 60. | 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission). | Posted | Mean | Standard Deviation | units on a scale | One month prior to admission to 30 days after discharge. |
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|
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| Secondary | Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process | During the 30 day post-discharge follow-up phone call we asked patients about their participation in, understanding of, and ability to carry out the post-discharge plan. These questions include questions from the Interpersonal Processes of Care survey and several additional questions from the HOMERUN study of readmitted patients. In the table below, we have abbreviated each survey question since the number of characters is limited in this field in the table. We have pasted below the full survey question.
| 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission). Not all patients answered the 30-day patient survey. | Posted | Number | proportion of participants | 30 days after discharge |
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| Secondary | Post-Discharge Health Care Utilization | We will measure emergency department visits and hospital readmissions within 30 days of discharge using a combination of administrative data for all Partners hospitals plus patient report for all utilization outside the Partners system. | Post Discharge ED visits within 30 days of discharge were not able to be obtained from the second site MGH. Post discharge readmissions were obtained, however, without the ED visit data from MGH we are unable to create a count for Post-Discharge Health Care Utilization (ED plus readmissions). | Posted | 30 days after discharge |
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| 0 |
| 978 |
| 0 |
| 978 |
| EG001 | Usual Care | Patients receive the care they would normally receive. | 0 | 679 | 0 | 679 |
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| Not given enough time to say what was important |
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| How often did care team listen carefully to you |
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| Felt pressured to have treatment not sure about |
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| Asked if you might have problems w/ recommended tx |
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| Understood what to do to care for self |
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| Able to take medications correctly every day |
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| Knew danger signs to watch and what to do |
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| Knew how to contact my doctor if needed |
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| Able to get to my doctor's appointment or tests |
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| Able to follow diet team ordered for me |
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| Had enough support from friends, family or others |
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