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Intervention to Increase Screening for Glucocorticoid Induced Diabetes (CDA-GID)

5 de junio de 2015 actualizado por: Liron Caplan MD, PhD, VA Eastern Colorado Health Care System
Using glucocorticoid induced diabetes (GID) we will conduct a small feasibility randomized intervention trial to improve GID management for veterans who are prescribed chronic glucocorticoids. Approximately 20 primary care providers (caring for approximately 100 veterans on chronic steroids) will receive decisional support (automatically-derived orders for hemoglobin A1C, to be co-signed by providers). Approximately 20 providers (caring for 100 veterans) who did not receive decisional support will serve as the control population. We will measure the time from randomization until the provider signs an order for hemoglobin A1C for both groups. The trial will be conducted at the VA's Eastern Colorado Health Care System (ECHCS) and will last approximately 6 months. After the completion of the trial for each provider, we will conduct a brief interview and survey of the participating providers to assess the acceptability of decisional support interventions to manage GID [protocol, page 1-2]. No patient data (PHI) will be collected by the providers.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

38

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Liron Caplan

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Decision Support Intervention
Clinical pharmacists mediated computerized decision support
Conductual: Decision support
Clinical pharmacists mediated computerized decision support
Comparador activo: Usual Care
Clinicians' typical approach for GID monitoring
Conductual: Usual Care
clinicians typical apporach for GID monitering

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility/Reach/Adoption
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

VA Eastern Colorado Health Care System

Investigadores

  • Investigador principal: Liron Caplan, MD, PhD, Veteran Affairs

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2012

Finalización primaria (Actual)

1 de marzo de 2014

Finalización del estudio (Actual)

1 de marzo de 2014

Fechas de registro del estudio

Enviado por primera vez

20 de noviembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

4 de diciembre de 2012

Publicado por primera vez (Estimar)

6 de diciembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de julio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

5 de junio de 2015

Última verificación

1 de junio de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 176843

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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