Personalized Decision Support for Older Patients With Diabetes

February 17, 2016 updated by: University of Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' change in knowledge about diabetes and its treatments
Time Frame: 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.
06/2011 - 12/2013 (32 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Change in Decisional Conflict Scores
Time Frame: 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.
6/2011 - 12/2013 (32 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Elbert S Huang, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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