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

This study is not yet open for participant recruitment.
Verified December 2012 by VA Eastern Colorado Health Care System
Sponsor:
Information provided by (Responsible Party):
Liron Caplan MD, PhD, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01743963
First received: November 20, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Glucocorticoid Induced Diabetes (GID)
 Behavioral: Decision support
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Intervention to Increase Screening for Glucocorticoid Induced Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • Delay Interval (days from randomization until the provider signs the order for a hgbA1C level). [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Feasibility/Reach/Adoption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).

  • Feasibility/Reach/Adoption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).

  • Feasibility/Reach/Adoption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).

  • Feasibility/Reach/Adoption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decision Support Intervention
Clinical pharmacists mediated computerized decision support
 Behavioral: Decision support
Clinical pharmacists mediated computerized decision support
Active Comparator: Usual Care
Clinicians' typical approach for GID monitoring
 Behavioral: Usual Care
clinicians typical apporach for GID monitering

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743963

Contacts
Contact: Liron Caplan, MD, PhD 7208575103 liron.caplan@ucdenver.edu
Contact: Lisa Davis, MD 7208575105 lisa.davis@ucdenver.edu

Locations
United States, Colorado
Liron Caplan Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Liron Caplan, MD, PhD     720-857-5103     liron.caplan@ucdenver.edu    
Contact: Lisa Davis, MD     7208575105     lisa.davis@ucdenver.edu    
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
Principal Investigator: Liron Caplan, MD, PhD Veteran Affairs
  More Information

No publications provided

Responsible Party: Liron Caplan MD, PhD, Associate Professor, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01743963     History of Changes
Other Study ID Numbers: 176843
Study First Received: November 20, 2012
Last Updated: December 13, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Eastern Colorado Health Care System:
efficacy
glucocorticoid

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013