iDecide.Decido: Diabetes Medication Decision Support Study

Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information

Sponsors

Lead Sponsor: University of Michigan

Collaborator: Agency for Healthcare Research and Quality (AHRQ)

Source University of Michigan
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.

Overall Status Completed
Start Date September 2011
Completion Date October 2013
Primary Completion Date September 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in decisional conflict baseline and 3 month post intervention
Secondary Outcome
Measure Time Frame
Medication adherence and intensification baseline and 3 month post intervention
Enrollment 190
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Community Health Worker Diabetes Education: Print media

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

Arm Group Label: Traditional CERSG Arm

Other Name: Print Materials Arm

Intervention Type: Behavioral

Intervention Name: CHW Diabetes Education: tailored web site

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

Arm Group Label: Web-Based Materials Arm

Other Name: 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

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michele Heisler, MD Principal Investigator University of Michigan Meidcal School; Ann Arbor VA Center for Clinical Management Research,
Location
Facility: Community Health and Social Service (CHASS)
Location Countries

United States

Verification Date

September 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Michigan

Investigator Full Name: Rebecca Mase

Investigator Title: Project Manager

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Traditional CERSG Arm

Type: Active Comparator

Description: 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.

Label: Web-Based Materials Arm

Type: Experimental

Description: 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.

Acronym iDecide
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov