Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Foundation for Informed Medical Decision Making
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00668590
First received: April 25, 2008
Last updated: April 8, 2011
Last verified: April 2011

April 25, 2008
April 8, 2011
August 2008
August 2010   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668590 on ClinicalTrials.gov Archive Site
Diabetes self-care behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
 
 
 
Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care
Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care

Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

  1. attitudes toward performing the behavior
  2. perceived social norms about performing the behavior
  3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.
 
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Diabetes
  • Behavioral: Patient video decision aid & telephone coaching
    The decision aid is a 30 minute video program that educates patients about their role in diabetes care. Telephone coaching will assist patients in initiating behavior change.
  • Behavioral: Printed educational brochure
    The printed brochure is an educational brochure developed by the NIH.
  • Experimental: 1
    Intervention: Behavioral: Patient video decision aid & telephone coaching
  • Active Comparator: 2
    Intervention: Behavioral: Printed educational brochure
Frosch DL, Uy V, Ochoa S, Mangione CM. Evaluation of a behavior support intervention for patients with poorly controlled diabetes. Arch Intern Med. 2011 Dec 12;171(22):2011-7. Epub 2011 Oct 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least 40 years old.
  2. Diagnosed with Type 2 diabetes at least 1 year ago.
  3. Attending the clinic for a routine diabetes follow-up visit.
  4. Completed at least 2 clinic visits in the past 12 months.
  5. Glycosylated hemoglobin A1c equal or greater than 8.0%
  6. Owns a DVD player and television at home
  7. Willing to provide informed consent.

Exclusion Criteria:

  1. Primary language other than English.
  2. Severe visual impairment
  3. Currently enrolled in a diabetes education or support program, or participated in a diabetes education or support program in the last 6 months.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668590
G08-01-038-01
No
Dominick L. Frosch, Ph.D., Assistant Professor, UCLA Department of Medicine
University of California, Los Angeles
  • Robert Wood Johnson Foundation
  • Foundation for Informed Medical Decision Making
Principal Investigator: Dominick L Frosch, Ph.D. University of California, Los Angeles
University of California, Los Angeles
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP