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
  Purpose

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.

Condition Intervention
Diabetes
Behavioral: Patient video decision aid & telephone coaching
Behavioral: Printed educational brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes self-care behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Active Comparator: 2 Behavioral: Printed educational brochure
The printed brochure is an educational brochure developed by the NIH.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668590

Locations
United States, California
UCLA Internal Medicine practices
Los Angeles, California, United States, 90024
Community-based primary care practices
Los Angeles, California, United States, 90291
Sponsors and Collaborators
University of California, Los Angeles
Robert Wood Johnson Foundation
Foundation for Informed Medical Decision Making
Investigators
Principal Investigator: Dominick L Frosch, Ph.D. University of California, Los Angeles
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dominick L. Frosch, Ph.D., Assistant Professor, UCLA Department of Medicine
ClinicalTrials.gov Identifier: NCT00668590     History of Changes
Other Study ID Numbers: G08-01-038-01
Study First Received: April 25, 2008
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014