NCT02130570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,679

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

2.4 years

First QC Date

May 1, 2014

Results QC Date

September 6, 2016

Last Update Submit

August 9, 2019

Conditions

Keywords

Adverse eventsReadmissionsPatient Centered Medical Home (PCMH)Accountable Care Organizations (ACO)Medication reconciliationDischarge AdvocatePatient engagementTransitions of careTransitions coachPharmacist intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge

    30 days after discharge

  • Number of Patients With a 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.

    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

    30 days after discharge

  • Post-Discharge Health Care Utilization

    30 days after discharge

Study Arms (2)

Multi-Model Intensive Discharge Program

EXPERIMENTAL

Multi-Model Intensive Discharge Program

Other: Multi-Model Intensive Discharge Intervention

Usual Care

NO INTERVENTION

Usual Care

Interventions

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: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information

Multi-Model Intensive Discharge Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Jeffrey L Schnipper, MD, MPH, FHM
Organization
Brigham and Women's Hospital

Study Officials

  • Jeffrey L Schnipper, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 5, 2014

Study Start

June 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 20, 2019

Results First Posted

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Voluntarily participating in PCORI's Open Science Pilot

Locations