Clinical trial NCT02246959: Process Versus Outcomes Incentives for Lipid Management
Official title: Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Cardiovascular Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Rutgers University
name: University of California, San Francisco
name: Carnegie Mellon University
name: Lancaster General Hospital
First posted: 2014-09-23
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in LDL cholesterol from baseline to 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Statin Adherence
timeFrame: 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Peter Reese, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Iwan Barankay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.