Financial Incentives for Medication Adherence (FIMA)
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|ClinicalTrials.gov Identifier: NCT01678183|
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : February 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Hypertension Hyperlipidemia||Behavioral: Monthly Financial Incentive Behavioral: Final Financial Incentive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Financial Incentives for Medication Adherence|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||January 2015|
Experimental: 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.
Behavioral: Monthly Financial Incentive
A cash payment.
Experimental: 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.
Behavioral: Monthly Financial Incentive
A cash payment.
Behavioral: Final Financial Incentive
One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
No Intervention: Control
These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.
- Improvement in hemoglobin A1c [ Time Frame: 8 months ]The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
- Improvement in blood pressure. [ Time Frame: Eight months ]The investigators will assess blood pressure measurements at the start and end of the study.
- Lipid levels [ Time Frame: Eight months ]The investigators will assess lipid levels at the start and end of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678183
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Elizabeth Rourke, MD||Boston Medical Center|
|Principal Investigator:||Amitabh Chandra, Ph.D.||Harvard Kennedy School, National Bureau of Economic Research|
|Principal Investigator:||Katherine Baicker, Ph.D.||Harvard School of Public Health, National Bureau of Economic Research|