iDecide.Decido: Diabetes Medication Decision Support Study - Full Text View

Purpose

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.

Condition	Intervention
Diabetes, Type 2	Behavioral: Community Health Worker Diabetes Education: Print media Behavioral: CHW Diabetes Education: tailored web site

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research
Official Title:	Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Changes in decisional conflict [ Time Frame: baseline and 3 month post intervention ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Medication adherence and intensification [ Time Frame: baseline and 3 month post intervention ] [ Designated as safety issue: No ]
Self-reported medication adherence will be assessed through three well-validated measures. We will assess changes in anti-hyperglycemic medication dosages and/or numbers of medications by patient report and medical record review.

Estimated Enrollment:	210
Study Start Date:	September 2011
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Behavioral: 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. Other Name: Print Materials Arm
Experimental: 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.	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. Other Name: Tailored web based decision aid

Arms

Assigned Interventions

Active Comparator: 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.

Behavioral: 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.

Other Name: Print Materials Arm

Experimental: 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.

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.

Other Name: Tailored web based decision aid

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427660

Contacts

Contact: Rebecca A. Mase, MSW	(734) 845-3973	rmase@umich.edu
Contact: Michele Heisler, MD	(734) 845-3614	mheisler@umich.edu

Locations

United States, Michigan
Community Health and Social Service (CHASS)	Recruiting
Detroit, Michigan, United States, 48209
Contact: Rebecca Mase, MSW rmase@umich.edu

Sponsors and Collaborators

University of Michigan

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:

Michele Heisler, MD

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

More Information

No publications provided

Responsible Party:	Rebecca Mase, Project Manager, University of Michigan
ClinicalTrials.gov Identifier:	NCT01427660 History of Changes
Other Study ID Numbers:	1R18HS019256-01
Study First Received:	August 31, 2011
Last Updated:	December 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Diabetes
Decision Aid
AntiHyperglycemic Medication
Tailored health information
Medication information

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013