Personalized Decision Support for Older Patients With Diabetes
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|ClinicalTrials.gov Identifier: NCT02169999|
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : February 19, 2016
The purpose of this study is to determine the impact of web-based personalized decision support on:
- Patient awareness of treatment goal options and ability to articulate their goals of diabetes care.
- Provider awareness of patients' clinical status (e.g. life expectancy) and treatment preferences.
- Individualization of care plans in accordance with geriatric diabetes guidelines.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Other: Personalized Diabetes Care Website||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Personalized Decision Support for Older Patients With Diabetes|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169999
|United States, Illinois|
|University of Chicago Hospitals|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Elbert S Huang||University of Chicago|