Financial Incentives for Medication Adherence (FIMA)
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Purpose
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 $40 for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive $40 for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study of $100 per full percent 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 | Intervention |
|---|---|
|
Diabetes Mellitus Hypertension Hyperlipidemia |
Behavioral: Monthly Financial Incentive Behavioral: Final Financial Incentive |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Financial Incentives for Medication Adherence |
- Improvement in hemoglobin A1c [ Time Frame: 8 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The investigators will assess blood pressure measurements at the start and end of the study.
- Lipid levels [ Time Frame: Eight months ] [ Designated as safety issue: No ]The investigators will assess lipid levels at the start and end of the study.
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2023 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Monthly Incentive
Subjects in this arm will receive a financial incentive of $40 in cash each month when they pick up their medications for diabetes, hypertension, and hypercholesterolemia at the pharmacy on time.
|
Behavioral: Monthly Financial Incentive
$40 per month in cash
|
|
Experimental: Monthly and Final Incentive
Subjects in this arm will receive a financial incentive of $40 in cash 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 of $100 for each full percentage point of decrease in their hemoglobin A1c over the eight-month course of the study.
|
Behavioral: Monthly Financial Incentive
$40 per month in cash
Behavioral: Final Financial Incentive
One-time payment of $100 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Elizabeth Rourke, MD | 617-414-6681 | elizabeth.rourke@bmc.org |
| United States, Massachusetts | |
| Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: Elizabeth Rourke, MD | |
| 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 |
More Information
No publications provided
| Responsible Party: | Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01678183 History of Changes |
| Other Study ID Numbers: | BU IRB H-30045, WS2069417 |
| Study First Received: | August 30, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hyperlipidemias Hypertension Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Dyslipidemias Lipid Metabolism Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013