iDecide.Decido: Diabetes Medication Decision Support Study

NCT01427660 | Completed

• 1 other identifier: 1R18HS019256-01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Type 2

Keywords

Diabetes; Decision Aid; AntiHyperglycemic Medication; Tailored health information; Medication information

Outcome Measures

Primary Outcomes (1)

• Changes in decisional conflict

  We will be measuring subjects' perceptions of: a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

  baseline and 3 month post intervention

Secondary Outcomes (1)

• Medication adherence and intensification

  baseline and 3 month post intervention

Study Arms (2)

Traditional CERSG Arm

ACTIVE COMPARATOR

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.

Behavioral: Community Health Worker Diabetes Education: Print media

Web-Based Materials Arm

EXPERIMENTAL

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.

Behavioral: CHW Diabetes Education: tailored web site

Interventions

Community Health Worker Diabetes Education: Print media BEHAVIORAL

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

Also known as: Print Materials Arm

Traditional CERSG Arm

CHW Diabetes Education: tailored web site BEHAVIORAL

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

Also known as: Tailored web based decision aid

Web-Based Materials Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Community Health and Social Service (CHASS)

Detroit, Michigan, 48209, United States

Location

Related Publications (1)

• 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.

  PMID: 25402398 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michele Heisler, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 1, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

US (1)