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

Sue Duval; Jeremy R Van't Hof; Niki C Oldenburg; Milton Eder; John R Finnegan Jr; Russell V Luepker

doi:10.1016/j.conctc.2021.100772

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

Contemp Clin Trials Commun. 2021 Apr 19:22:100772. doi: 10.1016/j.conctc.2021.100772. eCollection 2021 Jun.

Authors

Sue Duval¹, Jeremy R Van't Hof¹, Niki C Oldenburg¹, Milton Eder², John R Finnegan Jr³, Russell V Luepker^{1

3}

Affiliations

¹ Cardiovascular Division, University of Minnesota Medical School, Minneapolis, MN, USA.
² Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA.
³ Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.

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.

Keywords: Aspirin; Cardiovascular diseases; Cluster randomized trial; Group-randomized trial; Primary prevention; Protocol.

Associated data

ClinicalTrials.gov/NCT02607917