NCT02532296

Brief Summary

Improving hospital-to-home care transitions can produce improvements in patient safety and health care outcomes, while decreasing medical costs. Most transitions research has examined strategies for older patients. This project, however, focuses on younger, high-risk patients within a safety net system. The proposed intervention is based on research that patient activation, as measured by the Patient Activation Measure (PAM), is correlated with risk for hospital readmission. The intervention seeks to increase PAM scores by employing a Transition Coach to coach patients, prior to and for 30-days after discharge, to (1) improve self-management skills through goal setting and goal attainment; (2) to enhance patient capacity to engage in trusting relationships with the Primary Care Provider (PCP), other medical specialists, family members of friends, and the Transition Coach; and (3) to improve ability to navigate the medical system. The investigators will conduct a randomized trial to determine; (a) if PAM scores can be increased in the 30-day after hospital discharge; (b) if increased PAM scores, in this setting, are correlated with changes in healthcare utilization patterns; and (c) if the intervention presents a viable strategy to change healthcare utilization patterns and reduce rehospitalizations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

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, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

July 17, 2015

Last Update Submit

August 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline - Patient Activation Measure (PAM) and Utilization

    Comparison between pre-discharge PAM and 30-day post-discharge PAM. Hospital and ED visit and outpatient visits with PCP and Specialists at 7,14,30,60,90 days.

    7,14, 30, 60, 90 days post-discharge

Secondary Outcomes (6)

  • Goal Setting and Achievement

    Hospital visit and 30 days post-discharge

  • Relationship with Transition Coach (TC)

    Hospital visit and 30 days post-discharge

  • Relationship with PCP

    30 days post-discharge

  • Relationship with other medical providers

    30 days post-discharge

  • Relationship with Home Support

    30 days post-discharge

  • +1 more secondary outcomes

Other Outcomes (1)

  • Pre-intervention utilization

    1 year pre-hospitalization

Study Arms (2)

Control

ACTIVE COMPARATOR

Receive usual hospital discharge, care transition and post-discharge care.

Behavioral: Control

Transition Coach Intervention

EXPERIMENTAL

In addition to usual care, the intervention group receives care from a trained Transition Coach to support patients for 30 days after discharge.

Behavioral: Transition Coach (TC)

Interventions

TC reviews patient's medical record to understand current admission and the medical/psycho-social history. TC makes introductory hospital visit(s) with patient to establish rapport and to define post-discharge needs. Starting in-house and continuing after discharge, TC helps patient set transition goals to maximize healthcare outcomes. Post-discharge, TC offers a voluntary face-to-face visit with patient along with weekly outreach calls, which are designed to assist patient with goal setting and attainment, medical system navigation; medication management; medical follow-up; transportation; use of community resources; and self-care. Intervention lasts 30 days post-discharge; afterwards TC seeks to handoff to an outpatient care team member, to ensure continuity of care.

Transition Coach Intervention
ControlBEHAVIORAL

Receives usual hospital-based care, discharge preparation, transitional care and outpatient care.

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 60 or less
  • PCP within CHA network
  • Have had at least one previous hospitalization or two or more Emergency Department visit within CHA in the past year
  • Hospitalized at Cambridge Hospital on Medicine or Surgery Service
  • Discharged from Medicine or Surgery service to home

You may not qualify if:

  • Age \> 60;
  • Non-CHA PCP
  • Discharged to rehabilitation or transferred to an outside hospital or to Psychiatry service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Hospital

Cambridge, Massachusetts, 02139, United States

Location

Study Officials

  • Richard B Balaban, MD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

August 25, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations