- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05312229
Applying a Case Management Model in a VA Homeless Program
Implementación y mantenimiento de la intervención de tiempo crítico (CTI) en los programas de gestión de casos para veteranos sin hogar (PII 21-285)
The VA Grant and Per Diem (GPD) case management aftercare program provides six months of case management for homeless-experienced Veterans undergoing housing transitions. This Partnered Implementation Initiative (PII) proposes to implement and evaluate Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-in 32 GPD case management aftercare sites across the nation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The VA Grant and Per Diem case management (GPD-CM) program provides six months of case management for homeless-experienced Veterans (HEVs) undergoing housing transitions. At present, no specific case management paradigm is required in the GPD-CM program, resulting in practice variation across sites. This Partnered Implementation Initiative (PII) implements Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-at 32 VA GPD-CM sites. The investigators will use the Replicating Effective Programs (REP) implementation bundle to support CTI implementation at all 32 sites. Half of these sites will also receive 9 months of external facilitation (enhanced REP) as additional support for CTI implementation. In a type 3 hybrid trial, the investigators will use mixed methods to examine the impacts of REP versus enhanced REP. Using trial data, the investigators will develop a business case analysis and implementation playbook for the investigators' program partners to support continued CTI spread and sustainment in the GPD-CM program.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
West Los Angeles, California, Estados Unidos, 90073-1003
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Grant and Per Diem (GPD) case management aftercare grantees in 7 Veterans Integrated Service Networks (VISN), all of whom provide 6-months of case management to Veterans who have experienced homelessness
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Replicating Effective Programs (REP)
A stakeholder-informed training and technical assistance implementation strategy |
An evidence-based, structured, and time-limited case management practice
Otros nombres:
A stakeholder-informed training and technical assistance implementation strategy
Otros nombres:
|
|
Comparador activo: REP + External Facilitation (Enhanced REP)
REP plus site specific weekly facilitation to support critical time intervention (CTI) implementation. |
An evidence-based, structured, and time-limited case management practice
Otros nombres:
A stakeholder-informed training and technical assistance implementation strategy
Otros nombres:
Site-specific support to help sites develop tailored plans to implement critical time intervention (CTI)
Otros nombres:
|
|
Sin intervención: Control Group
No critical time intervention (CTI) implementation |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fidelity to critical time intervention (CTI)
Periodo de tiempo: 12 months after implementation start
|
% of Sites with adequate fidelity to CTI at 12 months, as measured by the CTI fidelity scale |
12 months after implementation start
|
|
Sustainment of critical time intervention (CTI)
Periodo de tiempo: 18 months after implementation start
|
% of Sites with adequate fidelity to CTI at 18 months, as measured by the CTI fidelity scale |
18 months after implementation start
|
|
Dollars spent delivering critical time intervention (CTI) at each site
Periodo de tiempo: Between 6 and 18 months after implementation start
|
Case manager salary and benefits |
Between 6 and 18 months after implementation start
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Housing stability
Periodo de tiempo: Between 6 and 18 months after implementation start
|
Days between entry into the GPD case management program and indicator of housing instability |
Between 6 and 18 months after implementation start
|
|
Cost of critical time intervention (CTI) as Implemented
Periodo de tiempo: Between 6 and 18 months after implementation start
|
Mean monthly cost of CTI case management per GPD case management Veteran served, compared to the mean monthly cost in the non-CTI GPD case management programs. |
Between 6 and 18 months after implementation start
|
|
Hospitalization rates
Periodo de tiempo: Between 6 and 18 months after implementation start
|
Number of days between entry into the GPD case management program and hospitalization, number of hospitalizations, number of bed days |
Between 6 and 18 months after implementation start
|
|
Cost of Implementation Strategies
Periodo de tiempo: Through study completion, 4 years
|
Dollars spent on REP versus enhanced REP |
Through study completion, 4 years
|
|
Return on Investment (ROI) of critical time intervention (CTI)
Periodo de tiempo: 6-, 12-, and 18-months after GPD case management program enrollment
|
Dollars saved via improved housing stability and decreased hospitalizations among patients engaged in CTI versus control participants |
6-, 12-, and 18-months after GPD case management program enrollment
|
|
Outpatient service use
Periodo de tiempo: Between 6 and 18 months after implementation start
|
Number of outpatient appointments |
Between 6 and 18 months after implementation start
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sonya Emi Gabrielian, MD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publicaciones y enlaces útiles
Publicaciones Generales
- Gabrielian S, Finley EP, Ganz DA, Barnard JM, Jackson NJ, Montgomery AE, Nelson RE, Cordasco KM. Comparing two implementation strategies for implementing and sustaining a case management practice serving homeless-experienced veterans: a protocol for a type 3 hybrid cluster-randomized trial. Implement Sci. 2022 Oct 3;17(1):67. doi: 10.1186/s13012-022-01236-1.
- Cummings C, Rawal M, Tan G, Finley E, Cordasco KM, Herman D, Edwards L, Gabrielian S. Assessing fidelity to Critical Time Intervention (CTI) for homeless-experienced persons. BMC Health Serv Res. 2026 Jun 16. doi: 10.1186/s12913-026-14939-8. Online ahead of print.
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 (Actual)
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
Otros números de identificación del estudio
- PIX 22-001
- PII 21-285 (Otro número de subvención/financiamiento: QUERI)
- 1I50HX003501-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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.
producto fabricado y exportado desde los 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. .