Intervention to Increase Screening for Glucocorticoid Induced Diabetes (CDA-GID)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Aim 1: Conduct a single site randomized controlled feasibility trial of a decisional support intervention to reduce ADRLLS by improving providers' adherence to GID prevention measures. Approximately 20 primary care providers (caring for approximately 100 veterans on chronic steroids who have not been screened for diabetes in the last year) will be randomly assigned to receive decisional support for GID prevention measures (automatically-derived orders for hemoglobin A1C, to be co-signed by providers). These providers will be compared with 20 providers (caring for 100 veterans not screened for diabetes in the last year) who are randomly assigned to not receive decisional support for management of GID (i.e. the control group). The trial will be conducted at the VA's Eastern Colorado Health Care System (ECHCS) and will last approximately 6 months. Study administration will be coordinated through the Colorado Research Award Enhancement Program (Colorado REAP).
Aim 1a) Procedural Endpoints: As a feasibility trial, this study includes multiple procedural endpoints, such as provider participation rates, to assess the viability of the intervention, rather than a single primary efficacy outcome measure (for details, pages 6-7).
Aim 1b) Preliminary Estimates of Efficacy: We will determine the Delay Interval-the number of days from when a provider is randomized until the provider orders the GID prevention measure. Use of this continuous measure will maximize the power of this feasibility study, though we will also determine proportions of patients for whom these measures were ordered at six months, so that we may estimate the sample size for a subsequent multi-center randomized control trial.
Aim 1c) Post-trial de-briefing: Using structured interviews, we will examine the opinions of providers after they have participated in the GID feasibility trial, in order to gather additional qualitative data regarding the ADRLL framework and refine the intervention for a subsequent randomized controlled trial. Providers will also complete a brief survey assessing their preference for the intervention.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Colorado
-
Aurora, Colorado, Estados Unidos, 80045
- Liron Caplan
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion criteria:
- Must be 18-90 years old
- Must be served by the ECHCS VA sytem
- Must have chronic glucocorticoid exposure (greater than or equal to 90 days of oral glucocorticoids)
- Eligible providers will consist of those primary care practitioners within the ECHCS with at least one patient meeting the above criteria. For each veteran, the primary care provider (PCP) will be defined as the patient's current general internal medicine or family practice practitioner. In the rare instance in which the patient has no PCP within the VA system, the specialist with the greatest number of patient encounters during the past 12 months will be eligible for inclusion. For every patient, only one provider will be randomized (to avoid multiple exposure to the intervention for some patients). The consent procedure is described below.
Exclusion Criteria:
- Veterans who have had a hgbA1C test within the previous 12 months will be excluded.
- Providers without eligible patients (described above), will be excluded.
- Providers declining to give consent will be excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Decision Support Intervention
Clinical pharmacists mediated computerized decision support
|
Clinical pharmacists mediated computerized decision support
|
|
Comparador Ativo: Usual Care
Clinicians' typical approach for GID monitoring
|
clinicians typical apporach for GID monitering
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).
Prazo: 6 MONTHS
|
For follow-up laboratory data within the VA system, adherence will be monitored through prospective accrual of administrative data and review of the medical record.
Results will be reported as the proportion receiving the preventive measure versus time, i.e. with Kaplan-Meier plots.
We will then determine the variance of Delay Interval.
For the preliminary measure of efficacy, the Delay Interval will be compared between patients whose providers were assigned to the intervention and patients whose providers did not receive the intervention.
|
6 MONTHS
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility/Reach/Adoption
Prazo: 12 months
|
Measurements of intervention delivery include recruitment numbers and provider Participation Rates for enrollment and retention.
The definition of study feasibility consists of provider enrollment rates >= 50%.
Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).
|
12 months
|
|
Feasibility/Reach/Adoption
Prazo: 12 months
|
Measurements of intervention delivery include the "representativeness" of providers (differences between participants/non-participants).
Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).
|
12 months
|
|
Feasibility/Reach/Adoption
Prazo: 12 months
|
Measurements of intervention delivery include the rationale used by clinicians declining participation.
Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).
|
12 months
|
|
Feasibility/Reach/Adoption
Prazo: 12 months
|
Measurements of intervention delivery include numbers of veterans excluded from the intervention.
Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Liron Caplan, MD, PhD, Veteran Affairs
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 176843
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 .