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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Professional Care Manager | Active Comparator | 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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| Peer Specialist Care Manager | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Management | Behavioral | Professionals and peers will each deliver the same intervention. The intervention combines a traditional medical model of care management with a recovery-based approach. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Outpatient Visits Attended | Outpatient engagement will be assessed by the percentage of outpatient visits attended. | 6 months after discharge |
| Number of Participants Being Readmitted to the Emergency Room |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Druss, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29203 | United States |
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Participant enrollment began in April 2017 and all follow-up visits were complete by December 31, 2019. Participants were enrolled from the patient population at 8 emergency departments in South Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Professional Care Manager | Participants meeting with a nurse or social worker to provide care management |
| FG001 | Peer Specialist Care Manager | Participants meeting with a peer specialist to provide care management |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population includes participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Professional Care Manager | Participants meeting with a nurse or social worker to provide care management |
| BG001 | Peer Specialist Care Manager | Participants meeting with a peer specialist to provide care management |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants completing the study are included in this analysis. | Posted | Count of Participants | Participants | 30 days after discharge |
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All-cause mortality events were collected from the time participants gave consent to take part in the study through the 6-month follow-up visit.
Only data on all-cause mortality events were collected during this study. All mortality events were reported to the Data Safety and Monitoring Board (DSMB) for review.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Professional Care Manager | Participants meeting with a nurse or social worker to provide care management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Druss, MD, MPH | Emory University | 404-712-9602 | bdruss@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 11, 2020 | Feb 26, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.
| 6 months after discharge |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Peer Specialist Care Manager | Participants meeting with a peer specialist to provide care management |
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| Secondary | Percentage of Outpatient Visits Attended | Outpatient engagement will be assessed by the percentage of outpatient visits attended. | This analysis includes participants who had at least one visit scheduled. | Posted | Mean | Standard Deviation | percentage of visits attended | 6 months after discharge |
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| 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. | This analysis includes participants for whom the 6-month follow-up data were available. | Posted | Count of Participants | Participants | 6 months after discharge |
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| 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. | This analysis includes participants for whom the 6-month follow-up data were available. | Posted | Count of Participants | Participants | 6 months after discharge |
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| 3 |
| 154 |
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| 0 |
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| EG001 | Peer Specialist Care Manager | Participants meeting with a peer specialist to provide care management | 2 | 162 | 0 | 0 | 0 | 0 |
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