Testing a Community Intervention to Increase Aspirin Use

NCT ID: NCT02607917

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-16
• Study Completion Date: 2020-07-01

Brief Summary

This research will test the effect of mass media or mass media plus a clinic based education program will improve appropriate aspirin use for cardiovascular disease prevention. It is a group randomized design of 24 geographic areas in Minnesota with adjacent states serving as controls.

Detailed Description

Proposed is a demonstration and implementation project to increase the appropriate use of aspirin for primary prevention of acute myocardial infarction and stroke in the population of Minnesota. Although significant progress in the reduction of acute myocardial infarction and stroke is apparent, these cardiovascular disorders continue as the leading causes of morbidity and mortality. In recent years, and in the context of the positive results from large randomized clinical trials, there is growing consensus that aspirin, when appropriately used, reduces cardiovascular morbidity in men aged 45-79 and women aged 55-79 years. The use of aspirin for primary prevention was recommended in the U.S. Preventive Services Task Force Report in 2009 and more recently in the CDC/CMS 'Million Hearts' ABCs (aspirin, blood pressure, cholesterol, smoking) campaign. Aspirin use is also recommended in the Healthy People 2020 goals. However, many adults who would benefit, are not taking aspirin.

The investigators have been fortunate to receive a large philanthropic donation to launch a campaign to increase appropriate aspirin use in the State of Minnesota. The proposed grant requests funding to evaluate that campaign and the innovative approaches it proposes. In the context of a innovative mass media effort, the investigators intend to test new methods for health system change to increase appropriate aspirin use. Using a two-arm design, the investigators have defined 24 geographic areas in the state that will form the basis for a group-randomized trial. This design will allow us to distinguish the effects of the intervention methods. The interventions will be evaluated by sequential surveys of the target-age general population at baseline and follow-up. Appropriate aspirin use in that population will be the primary goal and endpoint. Simultaneous surveys of adjacent Upper Midwestern states (Iowa, North and South Dakota, Wisconsin) will assess secular trends. Morbidity and mortality data will monitor disease trends and complications associated with aspirin use.

A substantial pilot study in a middle sized community in Northern Minnesota allows us to refine and validate our intervention and measurement methods at the community level. This pilot also demonstrated behavior change of a magnitude supportive of our design assumptions.

This program, if successful, should result in a generalizable program tested in a real world population setting.

Conditions

Myocardial Infarction; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mass Media plus clinic intervention.

These geographic areas will receive the media plus clinic intervention over a two year period.

Group Type: EXPERIMENTAL

Mass Media plus clinic intervention.

Intervention Type: OTHER

Media

These geographic areas will receive the media intervention over a two year period.

Group Type: EXPERIMENTAL

Media

Intervention Type: OTHER

No Intervention

Adjacent states will receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mass Media plus clinic intervention.

Intervention Type: OTHER

Media

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy men age 45-79.
• Healthy women age 55-79
• per USPSTF 2009 recommendations

Exclusion Criteria

• History of cardiovascular disease
• aspirin allergy
• serious life-limiting illness

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Roeser S, Duval S, Luepker RV, Eder M, Finnegan JR, Van't Hof JR. Population cessation of aspirin use for the prevention of cardiovascular disease. Am J Prev Cardiol. 2025 Feb 8;21:100941. doi: 10.1016/j.ajpc.2025.100941. eCollection 2025 Mar.

Reference Type: DERIVED

PMID: 40103687 (View on PubMed)

Luepker RV, Eder M, Finnegan JR, Van't Hof JR, Oldenburg N, Duval S. Association of a Community Population and Clinic Education Intervention Program With Guideline-Based Aspirin Use for Primary Prevention of Cardiovascular Disease: A Nonrandomized Controlled Trial. JAMA Netw Open. 2022 May 2;5(5):e2211107. doi: 10.1001/jamanetworkopen.2022.11107.

Reference Type: DERIVED

PMID: 35536579 (View on PubMed)

Duval S, Van't Hof JR, Oldenburg NC, Eder M, Finnegan JR Jr, Luepker RV. 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.

Reference Type: DERIVED

PMID: 34027223 (View on PubMed)

Krzyzanowski B, Manson SM, Eder MM, Kne L, Oldenburg N, Peterson K, Hirsch AT, Luepker RV, Duval S. Use of a Geographic Information System to create treatment groups for group-randomized community trials: The Minnesota Heart Health Program. Trials. 2019 Mar 28;20(1):185. doi: 10.1186/s13063-019-3284-9.

Reference Type: DERIVED

PMID: 30922358 (View on PubMed)

Other Identifiers

1201M8921

Identifier Type: -

Identifier Source: org_study_id