Personalized Decision Support for Older Patients With Diabetes

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT02169999
Collaborator
American Diabetes Association (Other)
100
1
2
30
3.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the impact of web-based personalized decision support on:

  1. Patient awareness of treatment goal options and ability to articulate their goals of diabetes care.

  2. Provider awareness of patients' clinical status (e.g. life expectancy) and treatment preferences.

  3. Individualization of care plans in accordance with geriatric diabetes guidelines.

Condition or Disease Intervention/Treatment Phase
  • Other: Personalized Diabetes Care Website
N/A

Detailed Description

In 2003, the first geriatric diabetes care guidelines were published that encouraged older patients and their providers to consider less intensive glucose control goals (HbA1C <8%) among frail, older patients with limited life expectancy, while continuing to pursue intensive glucose control (HbA1C <7%) among relatively healthy older patients. The guidelines also emphasized the importance of cardiovascular prevention, encouraged routine screening for geriatric syndromes that can influence treatment decisions (i.e., polypharmacy and falls), and advised providers to acknowledge patients' preferences when making treatment decisions.

These guidelines represent a conceptual advance in the care of older diabetes patients; however, there has been little effort to implement and evaluate these recommendations in a practice setting. This may be partially due to the fact that many of the recommendations are difficult to carry out in busy clinical practices without sophisticated decision support tools. Determining whether an older patient will benefit from intensive glucose control is a complex cognitive task requiring simultaneous consideration of multiple, sometimes contradictory, clinical criteria (e.g. advanced duration of diabetes and limited life expectancy). Completing this task accurately may only be possible with computer simulation models.

Along with this barrier to implementing care guidelines, there is also no consensus on how to elicit patient preferences in the setting of chronic disease management or how to account for these views in the decision-making process. To overcome these challenges, we developed a web-based Geriatric Diabetes Decision Aid (GDDA) which combines a decision analytic model of diabetes complications with the latest prognostic tools from geriatrics.

This personalized decision support tool will encourage the individualization of diabetes care among older patients by educating patients on diabetes, delivering prognostic information to providers, providing personalized data on the risks and benefits of diabetes care to patients and providers, and eliciting the treatment preferences of patients. In this proposed set of studies, we developed the GDDA with the input of patients and providers and assessed its impact through individual interviews.

The findings from this series of studies will be important for establishing the feasibility of using the GDDA in practice, and providing estimates of the intervention's effect on processes of care for power calculations for a future large scale randomized controlled trial. This pilot randomized controlled trial will be one of the first trials to formally examine new care recommendations for the growing population of older patients living with diabetes.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Official Title:
Personalized Decision Support for Older Patients With Diabetes
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Personalized Diabetes Care Website

Subjects are exposed to Personalized Diabetes Care website.

Other: Personalized Diabetes Care Website
Subjects enrolled in the intervention view the Personalized Diabetes Care website and enter their self-reported medical history and personal preferences into the website. A model runs and creates a 2 page print out with risk estimates for the subject to review with their physician.

No Intervention: No Exposure To Website

Subjects are not exposed to Personalized Diabetes Care website

Outcome Measures

Primary Outcome Measures

  1. Patients' change in knowledge about diabetes and its treatments [06/2011 - 12/2013 (32 months)]

    We asked patients to identify knowledge of an A1C goal and specific goals for glucose control in pre and post surveys for both arms.

Secondary Outcome Measures

  1. Patients' Change in Decisional Conflict Scores [6/2011 - 12/2013 (32 months)]

    We used the decision conflict scale (10-item) pre and post for both arms to measure any change in patients' decisional conflict regarding choosing their A1C goal.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 65 years of age or older

  • Dx of diabetes

  • HbA1C greater than 6.0%

  • English speaking

Exclusion Criteria:
  • Telephone Mini Mental less than 17

  • Blind

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Chicago Hospitals Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago
  • American Diabetes Association

Investigators

  • Principal Investigator: Elbert S Huang, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT02169999
Other Study ID Numbers:
  • 11-0045
First Posted:
Jun 23, 2014
Last Update Posted:
Feb 19, 2016
Last Verified:
Feb 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 19, 2016