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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Patient video decision aid & telephone coaching; Behavioral: Printed educational brochure

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA Internal Medicine practices
    • Los Angeles, California, United States, 90291
      • Community-based primary care practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1c	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diabetes self-care behaviors	6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Robert Wood Johnson Foundation; Foundation for Informed Medical Decision Making
• Investigators: Principal Investigator: Dominick L Frosch, Ph.D., University of California, Los Angeles

Publications and helpful links

General Publications

• 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. doi: 10.1001/archinternmed.2011.497. Epub 2011 Oct 10.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 25, 2008
• First Submitted That Met QC Criteria: April 25, 2008
• First Posted (Estimate): April 29, 2008

Study Record Updates

• Last Update Posted (Estimate): April 11, 2011
• Last Update Submitted That Met QC Criteria: April 8, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: G08-01-038-01