Intervention to Increase Screening for Glucocorticoid Induced Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Decision support; Behavioral: Usual Care

• Registration Number: NCT01743963
• Lead Sponsor: VA Eastern Colorado Health Care System

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2012-11-20
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2015-03-27
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-05
• Last Update Submitted: 2015-06-05
• Results First Posted: 2015-07-02
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision Support Intervention	Decision support	Clinical pharmacists mediated computerized decision support
Usual Care	Usual Care	Clinicians' typical approach for GID monitoring

Primary Outcome Measures

Name	Time	Method
Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility/Reach/Adoption	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).

Trial Locations

Locations (1)

Liron Caplan; 🇺🇸 Aurora, Colorado, United States