- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02130570
Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Likely discharge to a location other than home (or to a caregiver's home)
- Police custody
- No telephone or homeless
- Previous enrolment in the study
- Patient unable to communicate in either English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
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Experimental: Multi-Model Intensive Discharge Program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date
Time Frame: 30 days after discharge
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Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date
|
30 days after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge
Time Frame: 30 days after 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
Time Frame: 30 days after discharge
|
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.
Time Frame: 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.
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Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process
Time Frame: 30 days after discharge
|
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
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Post-Discharge Health Care Utilization
Time Frame: 30 days after discharge
|
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.
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30 days after discharge
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2012P000096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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