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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00668590
• Collaborator: Robert Wood Johnson Foundation (Other), Foundation for Informed Medical Decision Making (Other)
• Enrollment: 201
• Locations: 2
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 100.5
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Diabetes	Behavioral: Patient video decision aid & telephone coaching; Behavioral: Printed educational brochure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Official Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1c [6 months]

Secondary Outcome Measures

1. Diabetes self-care behaviors [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UCLA Internal Medicine practices	Los Angeles	California	United States	90024
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00668590
• Other Study ID Numbers: G08-01-038-01
• First Posted: Apr 29, 2008
• Last Update Posted: Apr 11, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: Diabetes
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Apr 11, 2011