Personalized Decision Support for Older Patients With Diabetes

Diabetes Clinical Trial

Official title:

Personalized Decision Support for Older Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169999
• Other study ID #: 11-0045
• Status: Completed
• Phase: N/A
• First received: June 18, 2014
• Last updated: February 17, 2016
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago Hospitals	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' change in knowledge about diabetes and its treatments	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)	No
Secondary	Patients' Change in Decisional Conflict Scores	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)	No