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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02989805
Other study ID # IRB00091841
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2017
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Existing literature indicates that there is potential effectiveness of care management delivered by mental health professionals in improving treatment engagement and reducing inpatient readmissions and that certified peer specialists may be able to deliver an array of mental health services of similar or better quality as mental health professionals. However, there have been no studies comparing certified peer specialists to professionals in interventions to increase treatment engagement and reduce readmissions. This study will be the first to examine the potential benefits and tradeoffs between these two groups of providers.

There is an urgent need to improve care transitions for patients with mental disorders seen in emergency departments (ED). Care management can improve treatment engagement after ED discharge for patients with mental disorders, and certified peer specialists hold promise in providing these services. However, there are no data comparing care management delivered by peers and professionals in these settings. With funding from a Patient-Centered Outcomes Research Institute (PCORI) grant the study team will be able to implement a manualized care management program to improve follow-up and treatment engagement for patients in South Carolina, supported by preliminary data and experience from work previously conducted by the study team.

The overall goal of the project is to compare the effectiveness of professional and peer care managers in improving linkage to and engagement in outpatient care after an 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, namely the Coordination, Access, Referral and Evaluation (CARE) Program with either a peer or professional care manager, resulting in a total of 290 participants. 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.


Recruitment information / eligibility

Status Completed
Enrollment 326
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Cognitive impairment

- Not able to speak English

- Admission to the hospital from the emergency department

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Emory University Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Outpatient Visits Attended Outpatient engagement will be assessed by the percentage of outpatient visits attended. 6 months after discharge
Secondary Number of Participants Being Readmitted to the Emergency Room The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here. 6 months after discharge
Secondary Number of Participants Being Admitted for Inpatient Hospitalization The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here. 6 months after discharge
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