Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 669
- 试验地点
- 2
- 主要终点
- Any incidence of hypoglycemia
研究概览
简要总结
As adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). This study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in value-aligned re-assessment of diabetes treatment regimens with their primary care team. If the aims of this project are achieved and incidence of clinically-significant hypoglycemia is reduced, this Prepare for Your Diabetes web-based patient educational care strategy could be scaled and applied in a wide variety of healthcare settings and chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.
详细描述
In this pragmatic, clinical efficacy, parallel group randomized clinical trial, the study will enroll eligible Kaiser Permanente Northern California members (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%). Participants randomly allocated to the intervention arm will view the Prepare for Your Diabetes Care web-based educational module that is designed to help them prepare to discuss their diabetes medication regimens with their primary care providers and receive an Action Plan handout. Participants randomly allocated to the control arm will continue with usual care. All participants will complete baseline, 6-month, and 12-month surveys. The hypothesis is that empowering high-risk patients to engage in values-based discussions about diabetes treatment intensity will result - when clinically appropriate - in decreases in diabetes regimen intensity leading to decreased incidence of hypoglycemia over the 12-month study period. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
care provider will not be informed of patient status; outcomes assessor will be blinded to allocation status
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years
- •Type 2 diabetes with last measured HbA1c ≤ 8.0%
- •Currently prescribed insulin and/or SUs
- •Kaiser Permanente Northern California member
排除标准
- •Unable to communicate in English
- •Unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits
- •Excluded by their primary care provider
研究组 & 干预措施
Educational Video and Action Plan handout
Patients in the intervention arm will be given access to an educational video (Prepare for Your Diabetes Care) and will be supported in viewing the video and the Action Plan handout.
This program will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps with the participant's primary care provider.
干预措施: Prepare for Your Diabetes Care (Behavioral)
Usual Care
Patients in the control arm will continue with usual care and also complete baseline, 6-month, and 12-month surveys
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Any incidence of hypoglycemia
时间窗: 12 months after baseline date
Any one of the following hypoglycemia event measures: * Self-report to survey question: Have you had three or more symptomatic hypoglycemia episodes in past 4 weeks (survey administered at month 6 and month 12) * Self-report to survey question: Have you had one or more severe hypoglycemia episodes in past 6 months that resulted in passing out or needing active help from someone else (survey administered at month 6 and month 12) * Clinical record of any emergency department or hospital admission with primary admitting diagnosis of hypoglycemia during the 12-month study period
次要结局
- Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia(Preceding 6-month period (asked 6 and 12 months after first study-related visit)])
- Clinical Utilization Outcome: Hypoglycemic-related admissions to Emergency Department or Hospital(6 and 12 months following the first study-related visit)
- Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions(6 and 12 months following the first study-related visit)
- Medication-Related Outcome: Aggregate measure of diabetes medication deprescribing(12 months following the first study-related visit)
- Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia(Preceding 1-month period (asked 6 and 12 months after first study-related visit))
- Patient-Reported Outcome: Problem Areas in Diabetes(6 and 12 months following the first study-related visit)
- Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire(6 and 12 months following the first study-related visit)
- Patient-Centered Outcome: Active Patient Participation during primary care visits(6 - 12 months following the first study-related visit)