Clinical trial NCT02130570: Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
Official title: Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Events
Readmissions
Patient Engagement
Keywords: Adverse events
Readmissions
Patient Centered Medical Home (PCMH)
Accountable Care Organizations (ACO)
Medication reconciliation
Discharge Advocate
Patient engagement
Transitions of care
Transitions coach
Pharmacist intervention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Massachusetts General Hospital
First posted: 2014-05-05
Enrollment: 1679
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The specific aims of this study are:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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:

1. Likely discharge to a location other than home (or to a caregiver's home)
2. Police custody
3. No telephone or homeless
4. Previous enrolment in the study
5. Patient unable to communicate in either English or Spanish

Primary outcomes:
measure: Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge
timeFrame: 30 days after discharge
measure: Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date
timeFrame: 30 days after discharge
measure: 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.
timeFrame: One month prior to admission to 30 days after discharge.
measure: Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process
timeFrame: 30 days after discharge
measure: Post-Discharge Health Care Utilization
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeffrey L Schnipper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: