Process Versus Outcomes Incentives for Lipid Management

NCT02246959 | Completed DMC

• 1 other identifier: 1R01HL118195-01A1
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Change in LDL cholesterol from baseline to 12 months

  12 months

Secondary Outcomes (1)

• Statin Adherence

  18 months

Study Arms (4)

Control Arm

NO INTERVENTION

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.

Process Arm

EXPERIMENTAL

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

Outcome Arm

EXPERIMENTAL

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

Process Plus Outcome Arm

EXPERIMENTAL

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; Behavioral: Outcome Incentive

Interventions

Process Incentive BEHAVIORAL

Daily sweepstake conditional on daily medication adherence

Process Arm; Process Plus Outcome Arm

Outcome Incentive BEHAVIORAL

Incentives conditional on LDL cholesterol reduction

Outcome Arm; Process Plus Outcome Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead
• Rutgers University: collaborator
• University of California, San Francisco: collaborator
• Carnegie Mellon University: collaborator
• Lancaster General Hospital: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 34605920 DERIVED

• 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.

  PMID: 33218296 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kevin Volpp, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Peter Reese, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Iwan Barankay, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: In a 4-arm, randomized controlled trial, we propose to 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.

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 23, 2014
• Study Start: February 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

US (1)