- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02933567
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care (CSCOnDemand)
Descripción general del estudio
Descripción detallada
Building on existing resources and the expertise of our faculty and advisors, we will develop CSC OnDemand, a multifaceted online learning product that includes four levels: 1) an online readiness tool and CSC Learning Hub; 2) dynamic multimedia core curriculum on first episode psychosis and CSC; 3) live faculty-led online courses; and 4) ongoing support, including an online community of practice to support peer-to-peer learning.
During Phases I and II of this Fast Track SBIR, we will prototype, pilot test, build out, and evaluate the product through a cluster randomized non-inferiority study comparing it with InPerson training.
Phase I will build a robust prototype of the online platform and test it with 15-20 providers from three sites. This Phase will explore feasibility, acceptability, and preliminary effectiveness of the product, and will examine which components of the online platform providers find most useful.
Based on our findings from Phase I, we will refine and fully build out the product to test in a larger randomized trial. Phase II will use a cluster randomized non-inferiority design to assess if OnDemand training (n = 20 sites) is comparable to InPerson training (n = 10 sites). Using a mixed-methods approach, we will examine provider (n = 150) outcomes (satisfaction; knowledge gains/retention; attitudes toward shared decision making) and client (n = 600) outcomes (work/school participation; engagement in CSC services; inpatient psychiatric hospitalizations).
The study is guided by the following specific aims:
Phase I AIM 1: To develop a prototype version of CSC OnDemand. AIM 2: To test the prototype online platform with a small sample of sites/providers to determine feasibility, acceptability, and preliminary effectiveness of the product.
Hypothesis: CSC OnDemand will show positive learning and satisfaction outcomes among providers, and findings will suggest the need for and feasibility of conducting a Phase II effectiveness trial.
Phase II AIM 1: To refine, expand, and finalize CSC OnDemand based on Phase I findings. AIM 2: To determine if the OnDemand training intervention is as successful as the InPerson intervention in increasing CSC providers knowledge and shared decision making (SDM). Hypothesis: Providers in the OnDemand condition will achieve increases in knowledge, SDM and satisfaction at post training and nine months that will be no more than .5 standard deviations less than the InPerson condition.
AIM 3: To determine if the OnDemand training intervention is as successful as the InPerson training in increasing participation in work or school, improving engagement in treatment, and decreasing relapse rates for participating clients.
Hypothesis: Clients being served by the providers in the OnDemand condition will have work/school participation rates, levels of engagement and rates of hospitalization nine months after admission that are no more than 10 percent higher (hospitalization) or lower (work/school, engagement) than clients served by providers in the InPerson condition.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Needham, Massachusetts, Estados Unidos, 02494
- Center for Social Innovation
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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: (providers in agencies)
To be eligible, agencies will need to provide:
- direct care to individuals with early psychosis;
- administrative-level support for training and use of the CSC model;
- an entire treatment team that is willing to participate in this team-based intervention;
- contact information for direct service staff;
- support for the study, including a staff person to serve as a liaison to work with the research team;
- access to the Internet during the intervention period; and
- a willingness to provide data and participate in the evaluation.
Exclusion criteria:
1. Teams should not have previously received CSC training.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CSC OnDemand Pilo
Pilot Intervention
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CSC OnDemand is a multifaceted online learning product that includes four levels: 1) an online readiness tool and CSC Learning Hub; 2) dynamic multimedia core curriculum on first episode psychosis and CSC; 3) live faculty-led online courses; and 4) ongoing support, including an online community of practice to support peer-to-peer learning.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knowledge Test: Percentage of correct responses on a 50-item, complex multiple choice knowledge (effectiveness) test that is both discipline-specific and inclusive of all disciplines.
Periodo de tiempo: 2 weeks
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Participants will be tested on preliminary effectiveness of the CSC OnDemand tool.
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2 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Satisfaction and Acceptability Survey: Level of satisfaction and acceptability with the CSC OnDemand tool as measured by quantitative and qualitative measures.
Periodo de tiempo: 2 weeks
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Participants will respond to satisfaction and acceptability questionnaires.
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2 weeks
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Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R44MH111283-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .