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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668590
• Other study ID #: G08-01-038-01
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: April 8, 2011
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2011
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• Printed educational brochure
The printed brochure is an educational brochure developed by the NIH.

Locations

Country	Name	City	State
United States	Community-based primary care practices	Los Angeles	California
United States	UCLA Internal Medicine practices	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Foundation for Informed Medical Decision Making, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		6 months	No
Secondary	Diabetes self-care behaviors		6 months	No