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Personalized Decision Support for Older Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169999
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : February 19, 2016
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date February 19, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Decision Support for Older Patients With Diabetes
Official Title  ICMJE Personalized Decision Support for Older Patients With Diabetes
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Personalized Diabetes Care Website
    Subjects are exposed to Personalized Diabetes Care website.
    Intervention: Other: Personalized Diabetes Care Website
  • No Intervention: No Exposure To Website
    Subjects are not exposed to Personalized Diabetes Care website
Publications * Huang ES, Nathan AG, Cooper JM, Lee SM, Shin N, John PM, Dale W, Col NF, Meltzer DO, Chin MH. Impact and Feasibility of Personalized Decision Support for Older Patients with Diabetes: A Pilot Randomized Trial. Med Decis Making. 2017 Jul;37(5):611-617. doi: 10.1177/0272989X16654142. Epub 2016 Jun 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169999
Other Study ID Numbers  ICMJE 11-0045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Elbert S Huang University of Chicago
PRS Account University of Chicago
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP