This trial is active, not recruiting.

Conditions adverse events, readmissions, patient engagement
Treatment multi-model intensive discharge intervention
Sponsor Brigham and Women's Hospital
Collaborator Patient Centered Outcome Research Institute
Start date June 2013
End date November 2015
Trial size 1679 participants
Trial identifier NCT02130570, 2012P000096


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
multi-model intensive discharge intervention
Inpatient medication safety interventions Inpatient "discharge advocate" Structured visiting nurse (VNA) appointments Post-discharge phone call by primary care personnel within 2 business days of discharge Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge Improved communication between inpatient and primary care teams High-risk patients will receive additional interventions as needed: Home pharmacist visit Enrollment in the Partners integrated Care Management Program (iCMP) Enrollment in telemedicine programs for patients with CHF Palliative care consultation regarding goals of care Novel health information technology to facilitate communication and transfer of clinical information
(No Intervention)

Primary Outcomes

Adverse events within 30 days of discharge
time frame: 30 days after discharge

Secondary Outcomes

Change in functional status from one month prior to admission to 30 days after discharge.
time frame: One month prior to admission to 30 days after discharge.
Patient Engagement and Opinions of the Discharge Process
time frame: 30 days after discharge
Post- Discharge Health Care Utilization
time frame: 30 days after discharge

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
Principal investigator Jeffrey L Schnipper, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.