Clinical trial NCT00668590: Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care
Official title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Foundation for Informed Medical Decision Making
First posted: 2008-04-29
Enrollment: 201
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
Secondary outcomes:
measure: Diabetes self-care behaviors
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Internal Medicine practices
state: California
city: Los Angeles
country: United States
facility: Community-based primary care practices
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Dominick L Frosch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.