Hypertension Clinical Trial
Official title:
Financial Incentives for Medication Adherence
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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