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Financial Incentives for Medication Adherence (FIMA)

Primary Purpose

Diabetes Mellitus, Hypertension, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monthly Financial Incentive
Final Financial Incentive
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Monthly Incentive

Monthly and Final Incentive

Control

Arm Description

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.

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.

These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.

Outcomes

Primary Outcome Measures

Improvement in hemoglobin A1c
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.
The investigators will assess blood pressure measurements at the start and end of the study.

Full Information

First Posted
August 30, 2012
Last Updated
January 30, 2015
Sponsor
Boston Medical Center
Collaborators
Pfizer, National Bureau of Economic Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01678183
Brief Title
Financial Incentives for Medication Adherence
Acronym
FIMA
Official Title
Financial Incentives for Medication Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Pfizer, National Bureau of Economic Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monthly Incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
Monthly and Final Incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.
Intervention Type
Behavioral
Intervention Name(s)
Monthly Financial Incentive
Intervention Description
A cash payment.
Intervention Type
Behavioral
Intervention Name(s)
Final Financial Incentive
Intervention Description
One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
Primary Outcome Measure Information:
Title
Improvement in hemoglobin A1c
Description
The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Improvement in blood pressure.
Description
The investigators will assess blood pressure measurements at the start and end of the study.
Time Frame
Eight months
Other Pre-specified Outcome Measures:
Title
Lipid levels
Description
The investigators will assess lipid levels at the start and end of the study.
Time Frame
Eight months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Rourke, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amitabh Chandra, Ph.D.
Organizational Affiliation
Harvard Kennedy School, National Bureau of Economic Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine Baicker, Ph.D.
Organizational Affiliation
Harvard School of Public Health, National Bureau of Economic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Financial Incentives for Medication Adherence

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