Financial Incentives for Medication Adherence (FIMA)
This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that many patients do not take their medications as prescribed by their doctors. This contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. The investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases.
The investigators plan to identify patients who get Primary Care at Boston Medical Center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. Subjects will be approached at the time of a regularly-scheduled appointment with their Primary Care doctor and offered the opportunity to participate in the study. All subjects who agree to participate in the study will meet with a Clinical Pharmacologist to review their medications in detail, and then undergo randomization. Subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients.
All patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. The observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients.
At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age greater than or equal to 18 years
- Speaks English, Spanish, or Haitian Creole
- Established patient in Boston Medical Center Section of General Internal Medicine Primary Care Practice
- Uses Boston Medical Center Pharmacy
- Diagnosed with diabetes for more than one year
- Prescribed medications for diabetes
- Last hemoglobin A1c > 7.9
Exclusion Criteria:
- Pregnant
- History of Brittle Diabetes
- Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Monthly Incentive
Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension, and hypercholesterolemia at the pharmacy on time.
The intervention is the cash incentive.
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A cash payment.
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实验性的:Monthly and Final Incentive
Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension and hypercholesterolemia at the pharmacy on time, as well as an additional financial incentive for each full percentage point of decrease in their hemoglobin A1c over the eight-month course of the study.
The two cash incentives are the intervention.
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A cash payment.
One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
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无干预:Control
These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in hemoglobin A1c
大体时间:8 months
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The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
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8 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in blood pressure.
大体时间:Eight months
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The investigators will assess blood pressure measurements at the start and end of the study.
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Eight months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lipid levels
大体时间:Eight months
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The investigators will assess lipid levels at the start and end of the study.
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Eight months
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合作者和调查者
调查人员
- 首席研究员:Elizabeth Rourke, MD、Boston Medical Center
- 首席研究员:Amitabh Chandra, Ph.D.、Harvard Kennedy School, National Bureau of Economic Research
- 首席研究员:Katherine Baicker, Ph.D.、Harvard School of Public Health, National Bureau of Economic Research
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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