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

• 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: Emory University
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Benjamin Druss, Emory University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Benjamin Druss, MD; Emory University

  Study Documents (Full-Text)

Documents provided by Benjamin Druss, Emory University:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] February 11, 2020

More Information

• Responsible Party: Benjamin Druss, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02989805
• Other Study ID Numbers: IRB00091841
• First Posted: December 12, 2016
• 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

• 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:

Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders