- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02989805
Engaging Patients With Mental Disorders From the ED in Outpatient Care (EPIC)
Engaging Patients With Mental Disorders From the ED in Outpatient Care: A Comparative Effectiveness Workforce Study of Peer Specialist vs. Professional Care Managers
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29203
- University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Professional Care Manager
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.
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Professionals and peers will each deliver the same intervention.
The intervention combines a traditional medical model of care management with a recovery-based approach.
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|
Experimental: Peer Specialist Care Manager
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.
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Professionals and peers will each deliver the same intervention.
The intervention combines a traditional medical model of care management with a recovery-based approach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Attending at Least One Outpatient Visit
Time Frame: 30 days after discharge
|
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.
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30 days after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Outpatient Visits Attended
Time Frame: 6 months after discharge
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Outpatient engagement will be assessed by the percentage of outpatient visits attended.
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6 months after discharge
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Number of Participants Being Readmitted to the Emergency Room
Time Frame: 6 months after discharge
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The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.
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6 months after discharge
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Number of Participants Being Admitted for Inpatient Hospitalization
Time Frame: 6 months after discharge
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The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.
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6 months after discharge
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin Druss, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00091841
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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