Intervention to Increase Screening for Glucocorticoid Induced Diabetes

NCT01743963 | Completed Results

• 1 other identifier: 176843
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

efficacy; glucocorticoid

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (4)

• Feasibility/Reach/Adoption

  12 months

• Feasibility/Reach/Adoption

  12 months

• Feasibility/Reach/Adoption

  12 months

• Feasibility/Reach/Adoption

  12 months

Study Arms (2)

Decision Support Intervention

EXPERIMENTAL

Clinical pharmacists mediated computerized decision support

Behavioral: Decision support

Usual Care

ACTIVE COMPARATOR

Clinicians' typical approach for GID monitoring

Behavioral: Usual Care

Interventions

Decision support BEHAVIORAL

Clinical pharmacists mediated computerized decision support

Decision Support Intervention

Usual Care BEHAVIORAL

clinicians typical apporach for GID monitering

Usual Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead

Study Sites (1)

Liron Caplan

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Liron Caplan, Primary Investigator
• Organization: Eastern Colorado Health Care System, VA

liron.caplan@ucdenver.edu

7208575103

Study Officials

• Liron Caplan, MD, PhD

  Veteran Affairs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 2, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-06

Locations

US (1)