- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02989805
Engaging Patients With Mental Disorders From the ED in Outpatient Care (EPIC)
Engaging Patients With Mental Disorders From the ED in Outpatient Care: A Comparative Effectiveness Workforce Study of Peer Specialist vs. Professional Care Managers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29203
- University of South Carolina
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
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Professionals and peers will each deliver the same intervention.
The intervention combines a traditional medical model of care management with a recovery-based approach.
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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.
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Professionals and peers will each deliver the same intervention.
The intervention combines a traditional medical model of care management with a recovery-based approach.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Attending at Least One Outpatient Visit
Periodo de tiempo: 30 days after discharge
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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.
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30 days after discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Outpatient Visits Attended
Periodo de tiempo: 6 months after discharge
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Outpatient engagement will be assessed by the percentage of outpatient visits attended.
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6 months after discharge
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Number of Participants Being Readmitted to the Emergency Room
Periodo de tiempo: 6 months after discharge
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The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.
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6 months after discharge
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Number of Participants Being Admitted for Inpatient Hospitalization
Periodo de tiempo: 6 months after discharge
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The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.
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6 months after discharge
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Benjamin Druss, MD, Emory University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00091841
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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