Process Versus Outcomes Incentives for Lipid Management

Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management

In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12 months.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Diabetes
• Intervention / Treatment: Behavioral: Process Incentive; Behavioral: Outcome Incentive

• Study Type: Interventional
• Enrollment (Actual): 764
• 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 to 90 years (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 ASCVD (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 ASCVD or diabetes with LDLC with an LDL greater than or equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%;
• Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl
• A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
• Low medication adherence on self-report completed during enrollment

Exclusion Criteria:

• Under 18 years old
• A contraindication to further statin use or have suffered statin side effects, such as myopathy
• Will not or cannot give consent
• A history of active or progressive liver disease
• Participating in another clinical trial with related aims
• Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)

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 electronic pill bottles for their statin medication but are not enrolled in the sweepstakes.
Experimental: Process Arm; Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.	Behavioral: Process Incentive; Daily sweepstake conditional on daily medication adherence
Experimental: Outcome Arm; Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL.	Behavioral: Outcome Incentive; Incentives conditional on LDL cholesterol reduction
Experimental: Process Plus Outcome Arm; Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.	Behavioral: Process Incentive; Daily sweepstake conditional on daily medication adherence; Behavioral: Outcome Incentive; Incentives conditional on LDL cholesterol reduction

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Statin Adherence	18 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: University of California, San Francisco; Lancaster General Hospital; 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.
• Reese PP, Barankay I, Putt M, Russell LB, Yan J, Zhu J, Huang Q, Loewenstein G, Andersen R, Testa H, Mussell AS, Pagnotti D, Wesby LE, Hoffer K, Volpp KG. Effect of Financial Incentives for Process, Outcomes, or Both on Cholesterol Level Change: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2121908. doi: 10.1001/jamanetworkopen.2021.21908.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 1R01HL118195-01A1 (U.S. NIH Grant/Contract)