- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02933567
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care (CSCOnDemand)
Visão geral do estudo
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Massachusetts
-
Needham, Massachusetts, Estados Unidos, 02494
- Center for Social Innovation
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: CSC OnDemand Pilo
Pilot Intervention
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
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.
Prazo: 2 weeks
|
Participants will be tested on preliminary effectiveness of the CSC OnDemand tool.
|
2 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Satisfaction and Acceptability Survey: Level of satisfaction and acceptability with the CSC OnDemand tool as measured by quantitative and qualitative measures.
Prazo: 2 weeks
|
Participants will respond to satisfaction and acceptability questionnaires.
|
2 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R44MH111283-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em CSC OnDemand
-
Center for Social Innovation, MassachusettsUniversity of Maryland; Dartmouth College; New York State Psychiatric InstituteConcluído
-
NYU Langone HealthNational Institute of Mental Health (NIMH)RetiradoPrimeiro Episódio Psicose (FEP)
-
Indiana UniversityNational Institute of Mental Health (NIMH); Yale University; University of Michigan e outros colaboradoresRecrutamentoEsquizofrenia | Transtorno esquizoafetivo | Depressão Maior com Características Psicóticas | Transtornos esquizofreniformes | Transtorno bipolar com características psicóticasEstados Unidos
-
Northwell HealthNational Institute of Mental Health (NIMH)RecrutamentoPrimeiro episódio de psicoseEstados Unidos
-
Zhujiang HospitalRecrutamento
-
Northwell HealthNational Institute of Mental Health (NIMH)RecrutamentoPrimeiro episódio de psicoseEstados Unidos
-
University of California, IrvineBeckman Laser Institute University of California IrvineConcluído
-
Fuda Cancer Hospital, GuangzhouUniversity of MichiganConcluído
-
University of AarhusAarhus University HospitalConcluído
-
Indiana UniversityNational Cancer Institute (NCI)ConcluídoCâncer colorretal | Câncer de Mama Feminino