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临床试验/NCT02169999
NCT02169999已完成不适用

Personalized Decision Support for Older Patients With Diabetes

University of Chicago1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Patients' change in knowledge about diabetes and its treatments

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •65 years of age or older
  • •Dx of diabetes
  • •HbA1C greater than 6.0%
  • •English speaking

排除标准

  • •Telephone Mini Mental less than 17

研究组 & 干预措施

Personalized Diabetes Care Website

Experimental

Subjects are exposed to Personalized Diabetes Care website.

干预措施: Personalized Diabetes Care Website (Other)

No Exposure To Website

No Intervention

Subjects are not exposed to Personalized Diabetes Care website

结局指标

主要结局

Patients' change in knowledge about diabetes and its treatments

时间窗: 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.

次要结局

  • Patients' Change in Decisional Conflict Scores(6/2011 - 12/2013 (32 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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