학술논문

A community-based group randomized trial to increase aspirin use for primary prevention of cardiovascular disease: Study protocol and baseline results for the 'Ask About Aspirin' initiative
Document Type
article
Source
Contemporary Clinical Trials Communications, Vol 22, Iss , Pp 100772- (2021)
Subject
Group-randomized trial
Cluster randomized trial
Cardiovascular diseases
Primary prevention
Aspirin
Protocol
Medicine (General)
R5-920
Language
English
ISSN
2451-8654
Abstract
Background: USPSTF evidence-based recommendations for the use of low-dose aspirin for primary prevention of cardiovascular disease were published in 2009. We describe a statewide campaign using innovative methods to educate the public and health communities about appropriate aspirin use. Methods/design: The “Ask About Aspirin” initiative is designed to lower the number of first heart attacks and strokes in the State of Minnesota by promoting the appropriate use of low dose aspirin. A health system intervention combined with an aspirin awareness media campaign will be evaluated in a pragmatic group randomized controlled trial including 267 primary care clinics within 84 health systems over a four year period. Matched pairs of geographic territories will be randomized to intervention (12 territories) or control (12 territories). The primary outcome of appropriate aspirin use will be measured at the individual level, by community-based telephone surveys of 100 participants in each of the 24 geographically determined clusters. Discussion: We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether evidence-based recommendations can be effectively disseminated in multiple health systems. Trial registration: ClinicalTrials.gov: NCT02607917.