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Engaging Patients With Mental Disorders From the ED in Outpatient Care (EPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02989805
Recruitment Status : Completed
First Posted : December 12, 2016
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Benjamin Druss, Emory University

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.

Condition or disease Intervention/treatment Phase
Mental Disorder Behavioral: Care Management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Engaging Patients With Mental Disorders From the ED in Outpatient Care: A Comparative Effectiveness Workforce Study of Peer Specialist vs. Professional Care Managers
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of Outpatient Visits Attended [ Time Frame: 6 months after discharge ]
    Outpatient engagement will be assessed by the percentage of outpatient visits attended.

  2. Number of Participants Being Readmitted to the Emergency Room [ Time Frame: 6 months after discharge ]
    The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.

  3. Number of Participants Being Admitted for Inpatient Hospitalization [ Time Frame: 6 months after discharge ]
    The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989805


Locations
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United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Emory University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Benjamin Druss, MD Emory University
  Study Documents (Full-Text)

Documents provided by Benjamin Druss, Emory University:

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Responsible Party: Benjamin Druss, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02989805    
Other Study ID Numbers: IRB00091841
First Posted: December 12, 2016    Key Record Dates
Results First Posted: March 16, 2020
Last Update Posted: March 16, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Druss, Emory University:
Emergency Medicine
Psychiatry
Health Promotion
Public Health
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders