Financial Incentives for Medication Adherence

NCT01678183 | Completed

• 2 other identifiers: BU IRB H-30045WS2069417
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Secondary Outcomes (1)

• Improvement in blood pressure.

  Eight months

Other Outcomes (1)

• Lipid levels

  Eight months

Study Arms (3)

Monthly Incentive

EXPERIMENTAL

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

Monthly and Final Incentive

EXPERIMENTAL

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; Behavioral: Final Financial Incentive

Control

NO INTERVENTION

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

Interventions

Monthly Financial Incentive BEHAVIORAL

A cash payment.

Monthly Incentive; Monthly and Final Incentive

Final Financial Incentive BEHAVIORAL

One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.

Monthly and Final Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• History of Brittle Diabetes
• Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c

Sponsors & Collaborators

• Boston Medical Center: lead
• Pfizer: collaborator
• National Bureau of Economic Research, Inc.: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

US (1)