Reducing Treatment Risk in Older Patients With Diabetes: Comparative Effectiveness of Academic Detailing With and Without Pre-Visit Patient Preparation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 8
- 主要终点
- Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing
研究概览
简要总结
This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.
详细描述
In this comparative effectiveness clinical trial, primary care physicians (PCPs) will receive 2 academic detailing sessions 6 months apart. Eligible patients (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%) of these PCPs will be randomized to receive either a pre-visit conversation aid/communication tool that elicits values and preferences regarding safe insulin/SU deprescribing [Intervention] or a general health education handout ("Embracing Life as You Age") [Attention Control]. Patient-reported outcomes (e.g., self-reported hypoglycemia episodes) and clinical outcomes (e.g., changes in glycemic regimen) will be compared between study arms. 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)
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 Hemoglobin A1c (HbA1c) ≤ 8.0%
- •currently prescribed insulin and/or sulfonylureas (SUs)
- •Kaiser Permanente Northern California member
排除标准
- •Given the requirements of this funding mechanism, we will not be able to develop new patient materials in languages other than English, and patients unable to communicate in English will be excluded.
- •Similarly, patients unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits will be excluded.
- •Excluded by their primary care provider
结局指标
主要结局
Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing
时间窗: 6 months after initial primary care visit
Aggregate binary measure of diabetes medication deprescribing between baseline and 6-month follow-up. Greater de-prescribing is better. De-prescribing defined as any combination of: 1. Discontinuation of either insulin or a sulfonylureas (SU) 2. Reduction in dose of insulin or SU, 3. Switch from a higher risk to lower risk version of insulin (e.g. from sliding scale insulin or basal-bolus insulin to twice daily basal insulin) and/or higher risk to lower risk oral medicine (e.g. switching from SU to other oral medicine less associated with hypoglycemia).
Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia
时间窗: Preceding 6 month period (asked 6 months after initial primary care visit)
Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else
次要结局
- Diabetes Treatment Satisfaction Questionnaire Scores(Asked 6 months after initial primary care visit)
- Number of Participants With Hypoglycemic-related Hospitalizations(6 months following the first study-related visit)
- RAND Patient Satisfaction Questionnaire(6 months following the first study-related visit)
- Perceived Efficacy in Patient - Physician Interactions(6 months following the first study-related visit)