Mental Disorder
Conditions
Keywords
Emergency Medicine, Psychiatry, Health Promotion, Public Health
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.
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.
Interventions
BEHAVIORALCare 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.
Sponsors
Patient-Centered Outcomes Research Institute
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Attending at Least One Outpatient Visit | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Outpatient Visits Attended | 6 months after discharge | Outpatient engagement will be assessed by the percentage of outpatient visits attended. |
| Number of Participants Being Readmitted to the Emergency Room | 6 months after discharge | The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here. |
| Number of Participants Being Admitted for Inpatient Hospitalization | 6 months after discharge | The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Professional Care Manager Participants meeting with a nurse or social worker to provide care management | 154 |
| Peer Specialist Care Manager Participants meeting with a peer specialist to provide care management | 162 |
| Total | 316 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | invalid consent | 6 | 4 |
Baseline characteristics
| Characteristic | Professional Care Manager | Total | Peer Specialist Care Manager |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 12.6 | 35.0 years STANDARD_DEVIATION 11.5 | 33.9 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 19 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 146 Participants | 297 Participants | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 67 Participants | 127 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 16 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 78 Participants | 166 Participants | 88 Participants |
| Region of Enrollment United States | 154 Participants | 316 Participants | 162 Participants |
| Sex: Female, Male Female | 85 Participants | 170 Participants | 85 Participants |
| Sex: Female, Male Male | 69 Participants | 146 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 154 | 2 / 162 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 30 days after discharge
Population: Participants completing the study are included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Professional Care Manager | Number of Participants Attending at Least One Outpatient Visit | 85 Participants |
| Peer Specialist Care Manager | Number of Participants Attending at Least One Outpatient Visit | 70 Participants |
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.
Time frame: 6 months after discharge
Population: This analysis includes participants for whom the 6-month follow-up data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Professional Care Manager | Number of Participants Being Admitted for Inpatient Hospitalization | 28 Participants |
| Peer Specialist Care Manager | Number of Participants Being Admitted for Inpatient Hospitalization | 35 Participants |
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.
Time frame: 6 months after discharge
Population: This analysis includes participants for whom the 6-month follow-up data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Professional Care Manager | Number of Participants Being Readmitted to the Emergency Room | 77 Participants |
| Peer Specialist Care Manager | Number of Participants Being Readmitted to the Emergency Room | 77 Participants |
Secondary
Percentage of Outpatient Visits Attended
Outpatient engagement will be assessed by the percentage of outpatient visits attended.
Time frame: 6 months after discharge
Population: This analysis includes participants who had at least one visit scheduled.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Care Manager | Percentage of Outpatient Visits Attended | 66.9 percentage of visits attended | Standard Deviation 24.9 |
| Peer Specialist Care Manager | Percentage of Outpatient Visits Attended | 66.2 percentage of visits attended | Standard Deviation 27.9 |