Financial Incentives for Medication Adherence (FIMA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pfizer
National Bureau of Economic Research, Inc.
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01678183
First received: August 30, 2012
Last updated: November 26, 2013
Last verified: October 2012
  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 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 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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678183

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Pfizer
National Bureau of Economic Research, Inc.
Investigators
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 26, 2013
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 July 31, 2014