An Intervention to Feedback 'Early' Non-Adherence Data to ImproveCardiovascular Disease Risk Factor Outcomes in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,378
- 试验地点
- 2
- 主要终点
- 120 day medication adherence
研究概览
简要总结
This multisite pragmatic clinical trial was designed to assess the effectiveness of a single scripted telephone call to diabetes patients who (a) were currently above recommended clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a new medication for that specific clinical domain. The goals of the intervention were to improve primary adherence and persistence to the newly prescribed medication and to improve control of glucose, blood pressure, and lipids.
详细描述
This randomized trial tested the hypothesis that a telephone contact with a patient recently prescribed a new medication for uncontrolled glycated hemoglobin (A1c), blood pressure, or low-density lipoprotein cholesterol would improve (a) primary medication adherence, (b) medication persistence, (c) medication possession ratio, and (d) A1c, blood pressure or low-density lipoprotein cholesterol control. This study was part of the larger Agency for Healthcare Research and Quality funded SUPREME-DM study. The clinical trial reported here was coordinated and led by HealthPartners Institute for Education and Research, while data collection was coordinated through Kaiser Permanente Northwest and analysis was conducted at Kaiser Permanente Colorado. The clinical intervention sites for this study included Kaiser Permanente Northern California, Group Health Cooperative, Marshfield Clinic, and Geisinger Clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At each clinical intervention site, study subjects were selected if they:
- •were age 18-75 years
- •met study criteria for diabetes mellitus before study enrollment
- •received clinical care at a designated clinic or medical center involved in this study for at least 15 months before enrollment
- •were prescribed a new class of medication (not filled in the past 180 days) for A1c, BP, or LDL that was uncontrolled at the time of medication prescription (A1c>=8%, systolic BP>= 140 mm Hg, or LDL >=100 mg/dL).
排除标准
- •Study subjects were excluded if they were younger than 18 years of age
- •Older than 75 years of age
- •Did not have evidence of diabetes mellitus prior to study enrollment
- •Were not receiving care at a clinic site involved in this study for at least 15 months before enrollment
- •Did not have prescribed a new class of medication for uncontrolled A1c, BP or LDL.
结局指标
主要结局
120 day medication adherence
时间窗: 120 days
In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) \>= 8%, Blood pressure \>= 140/90 mm Hg, or low-density lipoprotein cholesterol \>=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (b) \>=2 medication fills within 180 days of prescription,
60 day Medication Adherence
时间窗: 60 days
In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) \>= 8%, blood pressure \>= 140/90 mm Hg, or low-density lipoprotein cholesterol \>=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (a) first medication fill within 60 days of prescription,
次要结局
- Composite Control Level of Blood pressure, A1c and/or LDL(180 days)