Habit Formation for Adherence to Statin Use and LDL Reduction

Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk

In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use and sustained reductions in LDL cholesterol after financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to 12 months (6 months after cessation of financial incentives).

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Behavioral: Sweepstake Incentive 1; Behavioral: Sweepstake Incentive 2; Behavioral: Sweepstake Incentive 3

• Study Type: Interventional
• Enrollment (Actual): 805
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals at high risk of a cardiac event, specifically one of the following:
• Individuals with clinical CVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
• Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
• Individuals without clinical CVD or diabetes with LDL greater than or equal to 100 mg/dl and estimated 10-year CVD risk 7.5%;
• Individuals without clinical CVD or diabetes with LDL cholesterol greater than or equal to 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
• Medication Possession Ratio (MPR) less than or equal to 80%
• Low medication adherence on self-report completed during enrollment

Exclusion Criteria:

• Less than 18 years old
• Contraindication to further statin use or have suffered side effects from statins, such as myopathy
• Will not or cannot give consent
• History of active or progressive liver disease or abnormal liver function tests on baseline screening when applicable
• Currently participating in another clinical trial with related aims
• Co-morbidities likely to lead to death within a short-period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Arm 1 will be the Control arm, in which participants receive an electronic pill container and are provided with daily reminders to take their medication but are not enrolled in the sweepstakes.
Experimental: Sweepstakes Incentive 1; Arm 2 will be a sweepstakes incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.	Behavioral: Sweepstake Incentive 1; Daily sweepstake conditional on daily medication adherence
Experimental: Sweepstake Incentive 2; Arm 3 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which monetary prizes may be awarded if participants take their medication prior to receiving a reminder.	Behavioral: Sweepstake Incentive 2; Daily sweepstake conditional on daily medication adherence
Experimental: Sweepstake Incentive 3; Arm 4 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which each participant maintains an account that will accumulate money based on their medication adherence throughout the study.	Behavioral: Sweepstake Incentive 3; Daily sweepstake conditional on daily medication adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in LDL from baseline to 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Statin Adherence 6 months after active phase of intervention	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA); Rutgers University; Carnegie Mellon University
• Investigators: Principal Investigator: Peter Reese, MD, MSCE, University of Pennsylvania; Principal Investigator: Iwan Barankay, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• Russell LB, Norton LA, Pagnotti D, Sevinc C, Anderson S, Finnerty Bigelow D, Iannotte LG, Josephs M, McGilloway R, Barankay I, Putt ME, Reese PP, Asch DA, Goldberg LR, Mehta SJ, Tanna MS, Troxel AB, Volpp KG. Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists. Med Decis Making. 2021 Jan;41(1):9-20. doi: 10.1177/0272989X20973160. Epub 2020 Nov 20.
• Barankay I, Reese PP, Putt ME, Russell LB, Phillips C, Pagnotti D, Chadha S, Oyekanmi KO, Yan J, Zhu J, Volpp KG, Clapp JT. Qualitative Exploration of Barriers to Statin Adherence and Lipid Control: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e219211. doi: 10.1001/jamanetworkopen.2021.9211.
• Barankay I, Reese PP, Putt ME, Russell LB, Loewenstein G, Pagnotti D, Yan J, Zhu J, McGilloway R, Brennan T, Finnerty D, Hoffer K, Chadha S, Volpp KG. Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019429. doi: 10.1001/jamanetworkopen.2020.19429.
• Putt ME, Reese PP, Volpp KG, Russell LB, Loewenstein G, Yan J, Pagnotti D, McGilloway R, Brennen T, Finnerty D, Hoffer K, Chadha S, Barankay I. The Habit Formation trial of behavioral economic interventions to improve statin use and reduce the risk of cardiovascular disease: Rationale, design and methodologies. Clin Trials. 2019 Aug;16(4):399-409. doi: 10.1177/1740774519846852. Epub 2019 May 31.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1R01AG043844-01 (U.S. NIH Grant/Contract); 5R01AG043844 (U.S. NIH Grant/Contract)