NCT02989805

Brief Summary

This study will compare the effectiveness of professional and peer care managers in improving linkage to and engagement in outpatient care after an emergency department (ED) discharge, as well as the mechanisms by which engagement occurs. The study will use a multi-site randomized trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site will have one professional care manager (social worker or nurse) and one peer specialist care manager. Eligible subjects at each site will be randomized to a one-year treatment engagement intervention, the Coordination, Access, Referral and Evaluation (CARE) Program with either a peer or professional care manager, resulting in a total of 290 participants across sites. The CARE program will focus on shared decision-making between care managers and patients, and combines the traditional medical model of care management with a recovery-based approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

February 1, 2020

Enrollment Period

2.7 years

First QC Date

December 8, 2016

Results QC Date

February 27, 2020

Last Update Submit

February 27, 2020

Conditions

Keywords

Emergency MedicinePsychiatryHealth PromotionPublic Health

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Attending at Least One Outpatient Visit

    This outcome was operationally measured as at least one outpatient visit for a mental health problem in the 30 days after discharge from the emergency department. Data were obtained from the South Carolina Office of Revenue and Fiscal Affairs (RFA). The RFA data warehouse pulls client-specific data from an array of health and human services facilities, agencies and organizations and makes possible the integration of data from disparate sources at the client level by means of an internally assigned unique tracking number.

    30 days after discharge

Secondary Outcomes (3)

  • Percentage of Outpatient Visits Attended

    6 months after discharge

  • Number of Participants Being Readmitted to the Emergency Room

    6 months after discharge

  • Number of Participants Being Admitted for Inpatient Hospitalization

    6 months after discharge

Study Arms (2)

Professional Care Manager

ACTIVE COMPARATOR

Each participating site will have a nurse or social worker to provide care management. Training activities will include modules for each of the key domains covered in the intervention: shared decision making, action planning; motivational interviewing; and mental health as a cornerstone of recovery, working effectively within the mental health system; and self-care and stress management.

Behavioral: Care Management

Peer Specialist Care Manager

EXPERIMENTAL

Each participating site will have a peer specialist to provide care management. Peer specialists will have a minimum of a high school education, a history of a mental illness, be self-described as 'in recovery,' and have reliable transportation to the study site. All certified peer specialists will receive training in a curriculum that supports identifying and pursuing goals for recovery; developing and documenting recovery-focused treatment plans; and supporting linkages with community-based services. Peers learn to help other individuals with mental health conditions to facilitate mental health dialogues; explore mental health choices and options; identify and work with a clinician; and obtain access to community health supports.

Behavioral: Care Management

Interventions

Care ManagementBEHAVIORAL

Professionals and peers will each deliver the same intervention. The intervention combines a traditional medical model of care management with a recovery-based approach.

Peer Specialist Care ManagerProfessional Care Manager

Eligibility Criteria

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

You may qualify if:

  • Admission to the emergency department for a primary diagnosis of a mental disorder
  • Plan for discharge to a participating community mental health center (CMHC)
  • Lives within the CMHC catchment area

You may not qualify if:

  • Cognitive impairment
  • Not able to speak English
  • Admission to the hospital from the emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

Title
Benjamin Druss, MD, MPH
Organization
Emory University

Study Officials

  • Benjamin Druss, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 12, 2016

Study Start

April 3, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 16, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-02

Locations