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

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ClinicalTrials.gov Identifier: NCT02989805
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : May 2, 2018
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 1000 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. Follow-up interviews at baseline, 6 months and 12 months will assess outpatient treatment engagement after discharge from the ED, changes in mental health and clinical outcomes, and changes in attitudinal and logistical barriers to obtaining services.

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 1000 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. Follow-up interviews at baseline, 6 months and 12 months will assess outpatient treatment engagement after discharge from the ED, changes in mental health and clinical outcomes, and changes in attitudinal and logistical barriers to obtaining services.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

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. Outpatient treatment engagement after emergency department discharge [ Time Frame: 30 days after discharge ]
    This outcome will be operationally measured as at least one outpatient visit for a mental health problem in the 30 days after discharge from the emergency department. Data will be obtained from the South Carolina Office of Research and Statistics (ORS). The ORS 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. Outpatient engagement [ Time Frame: 12 months ]
    The proportion of outpatient visits attended and attending at least 4 scheduled outpatient visits

  2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) scores [ Time Frame: Baseline, 6 months, 12 months ]
    These are patient-reported outcome measures that assess physical and mental health, alcohol and drug use, and social functioning

  3. Change in Recovery Assessment Scale score [ Time Frame: Baseline, 6 months, 12 months ]
    The Recovery Assessment Scale is a 41-item measure that assesses personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and symptom management. Respondents indicate the degree to which they agree with each statement by selecting "strongly disagree" (1), "disagree" (2), "not sure" (3), "agree" (4), or "strongly agree" (5).

  4. Change in Barriers to Care survey score [ Time Frame: Baseline, 6 months, 12 months ]
    This study will use a survey modeled after the National Comorbidity Survey Replication (NCS-R). The Barriers to Care survey includes sections for attitudinal and logistical barriers.



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

Exclusion Criteria:

  • Cognitive impairment
  • Not able to speak English

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


Contacts
Contact: Benjamin Druss, MD 404.727.6979 bdruss@emory.edu

Locations
United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Contact: Laura Reparaz    803-434-1100    Laura.Reparaz@uscmed.sc.edu   
Sponsors and Collaborators
Emory University
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Benjamin Druss, MD Emory University

Responsible Party: Benjamin Druss, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02989805     History of Changes
Other Study ID Numbers: IRB00091841
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
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:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders