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iDecide.Decido: Diabetes Medication Decision Support Study (iDecide)

Primary Purpose

Diabetes, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Health Worker Diabetes Education: Print media
CHW Diabetes Education: tailored web site
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes, Type 2 focused on measuring Diabetes, Decision Aid, AntiHyperglycemic Medication, Tailored health information, Medication information

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Community Health and Social Service (CHASS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional CERSG Arm

Web-Based Materials Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Medication adherence and intensification
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.

Full Information

First Posted
August 31, 2011
Last Updated
September 8, 2014
Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01427660
Brief Title
iDecide.Decido: Diabetes Medication Decision Support Study
Acronym
iDecide
Official Title
Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 2
Keywords
Diabetes, Decision Aid, AntiHyperglycemic Medication, Tailored health information, Medication information

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional CERSG Arm
Arm Type
Active Comparator
Arm 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.
Arm Title
Web-Based Materials Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker Diabetes Education: Print media
Other Intervention Name(s)
Print Materials Arm
Intervention Description
Providing information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.
Intervention Type
Behavioral
Intervention Name(s)
CHW Diabetes Education: tailored web site
Other Intervention Name(s)
Tailored web based decision aid
Intervention Description
Providing tailored and interactive information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.
Primary Outcome Measure Information:
Title
Changes in decisional conflict
Description
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.
Time Frame
baseline and 3 month post intervention
Secondary Outcome Measure Information:
Title
Medication adherence and intensification
Description
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.
Time Frame
baseline and 3 month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Heisler, MD
Organizational Affiliation
University of Michigan Meidcal School; Ann Arbor VA Center for Clinical Management Research,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health and Social Service (CHASS)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25402398
Citation
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.
Results Reference
derived

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iDecide.Decido: Diabetes Medication Decision Support Study

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