Comparison of Outreach Approaches to Increase Enrollment in a Healthy Cholesterol Study

A Randomized Controlled Trial of Outreach Approaches to Increase Enrollment in the Habit Formation for Adherence to Statin Use and LDL Reduction Study

This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the study by enrolling on an online platform. Group 1 will receive the recruitment letter in a normal sized envelope, Group 2 will receive the recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image of an Amazon gift card and told they will receive a $25 gift card if they enroll in the study. All other groups are told that they will receive a $25 check upon enrollment in the study.

Inclusion Criteria:

• Diabetes and or history of CVD
• LDL > or = 130 mg/dl - measured during screening
• A prescription filled for statin medication within the last 12 months
• Medication Possession Ratio (MPR) <80%
• CVS Caremark Beneficiary

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
• Currently participating in another clinical trial with related aims
• Co-morbidities likely to lead to death within a short-period