Clinical trial NCT01798784: Habit Formation for Adherence to Statin Use and LDL Reduction
Official title: Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
name: Rutgers University
name: National Institute on Aging (NIA)
First posted: 2013-02-26
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in LDL from baseline to 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Statin Adherence 6 months after active phase of intervention
timeFrame: 6 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: Iwan Barankay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Peter Reese, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.