iDecide.Decido: Diabetes Medication Decision Support Study

NCT ID: NCT01427660

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-10-31

Brief Summary

Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research [CHCR] and Center for Behavioral and Decision Sciences in Medicine [CBDSM]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.

Detailed Description

The Specific Aims of this study are:

Aim 1: To use the information in the two diabetes medications consumer CERSGs to build an interactive, computer tailored diabetes medication guide that will enable patients to assess their treatment goals, personal preferences, and side-effect concerns and generate a personally tailored assessment of their current diabetes treatments with, as appropriate, options for improving their diabetes care;

Aim 2: To determine the extent to which this personally tailored diabetes medication guide compared with the print consumer guides reduces Latino and African American diabetes patients' decisional conflict, through improved knowledge of anti-hyperglycemic medications and satisfaction with information received.

Aim 3: To examine the computer tailored program's effects on participants' changes in medications (medication intensification), self-reported medication adherence and beliefs and A1C levels between baseline and follow-up compared to participants receiving the print consumer guides.

Conditions

Diabetes, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Traditional CERSG Arm

CHWs will provide and review with patients language-appropriate versions of the AHRQ consumer guides. CHWs will highlight key points on each page, review information on each medication and elicit and address questions. They will use the autonomy enhancing, motivational-interviewing based skills. As with the first arm, CHWs will schedule follow-up clinic appointments for participants who note a specific treatment change they would consider and will call participants two times after the session at three and six weeks to address additional questions and to follow up on any goals the participant set.

Group Type: ACTIVE_COMPARATOR

Community Health Worker Diabetes Education: Print media

Intervention Type: BEHAVIORAL

Providing information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.

Web-Based Materials Arm

Participants randomized to this arm will be scheduled within 3 weeks of enrollment to have a one-hour face-to-face session with a CHW who will deliver the ipad platform personally tailored diabetes medication decision aid. Participants will receive a printed tailored preference summary at the completion of this visit. If participants note a specific treatment change they would like to discuss with their providers, the CHW will facilitate scheduling a clinic visit within the next month. Finally, CHWs will call participants two times after the session at 3 and 6 weeks to assess if the participant has additional questions and to follow up on any treatment or other goals the participant set during their session.

Group Type: EXPERIMENTAL

CHW Diabetes Education: tailored web site

Intervention Type: BEHAVIORAL

Providing tailored and interactive information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.

Interventions

Community Health Worker Diabetes Education: Print media

Providing information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.

Intervention Type: BEHAVIORAL

CHW Diabetes Education: tailored web site

Providing tailored and interactive information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.

Intervention Type: BEHAVIORAL

Other Intervention Names

Print Materials Arm; Tailored web based decision aid

Eligibility Criteria

Inclusion Criteria

• type 2 diabetes
• stated concern about diabetes and diabetes treatment
• poor glycemic control
• over 21 years of age

Exclusion Criteria

• blind, deaf, otherwise unable to use the telephone or visual resources
• pregnant
• currently enrolled in other REACH Detroit research study
• in hospice care
• current radiation or chemotherapy

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Mase

Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Heisler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Meidcal School; Ann Arbor VA Center for Clinical Management Research,

Locations

Community Health and Social Service (CHASS)

Detroit, Michigan, United States

Countries

United States

References

Heisler M, Choi H, Palmisano G, Mase R, Richardson C, Fagerlin A, Montori VM, Spencer M, An LC. Comparison of community health worker-led diabetes medication decision-making support for low-income Latino and African American adults with diabetes using e-health tools versus print materials: a randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S13-22. doi: 10.7326/M13-3012.

Reference Type: DERIVED

PMID: 25402398 (View on PubMed)

Other Identifiers

1R18HS019256-01

Identifier Type: AHRQ

Identifier Source: org_study_id

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