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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
Sponsor:
Collaborators:
Pfizer
National Bureau of Economic Research, Inc.
Information provided by (Responsible Party):
Boston Medical Center

Tracking Information
First Submitted Date  ICMJE August 30, 2012
First Posted Date  ICMJE September 3, 2012
Last Update Posted Date February 2, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
Improvement in hemoglobin A1c [ Time Frame: 8 months ]
We will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
Improvement in blood pressure. [ Time Frame: Eight months ]
The investigators will assess blood pressure measurements at the start and end of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
Improvement in blood pressure. [ Time Frame: Eight months ]
We will assess blood pressure measurements at the start and end of the study.
Current Other Pre-specified Outcome Measures
 (submitted: November 5, 2012)
Lipid levels [ Time Frame: Eight months ]
The investigators will assess lipid levels at the start and end of the study.
Original Other Pre-specified Outcome Measures
 (submitted: August 31, 2012)
Lipid levels [ Time Frame: Eight months ]
We will assess lipid levels at the start and end of the study.
 
Descriptive Information
Brief Title  ICMJE Financial Incentives for Medication Adherence
Official Title  ICMJE Financial Incentives for Medication Adherence
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Hypertension
  • Hyperlipidemia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Monthly Financial Incentive
  • 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.
    Interventions:
    • Behavioral: Monthly Financial Incentive
    • Behavioral: Final Financial Incentive
  • No Intervention: Control
    These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2015)
74
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
100
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678183
Other Study ID Numbers  ICMJE BU IRB H-30045
WS2069417 ( Other Grant/Funding Number: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE
  • Pfizer
  • National Bureau of Economic Research, Inc.
Investigators  ICMJE
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
PRS Account Boston Medical Center
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP