Process Versus Outcomes Incentives for Lipid Management

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT02246959

Collaborator

Rutgers University (Other), University of California, San Francisco (Other), Carnegie Mellon University (Other), Lancaster General Hospital (Other)

764

Enrollment

Location

Arms

Duration (Months)

17.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Cardiovascular Disease	Behavioral: Process Incentive Behavioral: Outcome Incentive	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

764 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in LDL cholesterol from baseline to 12 months [12 months]

Secondary Outcome Measures

Statin Adherence [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania
Rutgers University
University of California, San Francisco
Carnegie Mellon University
Lancaster General Hospital

Investigators

Principal Investigator: Kevin Volpp, MD, PhD, University of Pennsylvania
Principal Investigator: Peter Reese, MD, MSCE, University of Pennsylvania
Principal Investigator: Iwan Barankay, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT02246959

Other Study ID Numbers:

1R01HL118195-01A1

First Posted:

Sep 23, 2014

Last Update Posted:

Feb 26, 2019

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Feb 26, 2019