Shared Decision Making Tools for Cardiovascular Prevention

(SDM4IP Trial)

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Non-English speakers, Cognitive deficits

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

112127 Participants Needed

Trial Summary

What is the purpose of this trial?

Cardiovascular (CV) disease is the #1 cause of premature mortality and substantial morbidity in the U.S. Despite clinical guidelines, most clinical interventions are implemented in people at relatively lower CV risk, and few among people at the highest risk. Shared decision making (SDM) can mitigate the risk-treatment paradox by reducing risk blindness and lack of fit of the preventive regimen, but the adoption of SDM in routine clinical care is incomplete. This study addresses SDM adoption of a CV prevention SDM tool in three health systems.

Research Team

Jennifer Ridgeway, PhD

Principal Investigator

Mayo Clinic

Victor Montori, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 40-75 who are at risk of cardiovascular disease but haven't had a heart attack or stroke. It's open to those with or without diabetes receiving care at certain clinics. Clinicians from these practices can also join. People who don't speak English or have cognitive issues affecting consent are excluded.

Inclusion Criteria

Clinician Participants: All clinicians who are affiliated with a participating primary care practice and care for adult patients eligible for CV prevention will be invited to participate.

I am between 40-75 years old, may or may not have diabetes, and have never had a clot-related heart or brain event.

Exclusion Criteria

Individuals who do not speak English or have any sort of cognitive deficit that would impact their ability to consent to participate in the study will not be invited to participate.

Treatment Details

Interventions

• CV Prevention Choice Tool
• Implementation Facilitation Strategies

Trial Overview The study tests a Shared Decision Making (SDM) tool designed to improve individualized cardiovascular prevention strategies in clinical settings, aiming to better match treatments with patient risks across three health systems.

Participant Groups

Group I: Health Systems - Third Step Experimental Treatment 1 Intervention

Each health system will consist of clinicians who are affiliated with primary care practices and patients who are eligible for CV primary prevention discussions.In the third step, all health systems will move to maintenance implementation.

Group II: Health Systems - Second Step Experimental Treatment 2 Interventions

Each health system will consist of clinicians who are affiliated with primary care practices and patients who are eligible for CV primary prevention discussions. In the second step, health systems (in an order to be determined by randomization and staggered over time) will move into active implementation.

Group III: Health Systems - First Step Experimental Treatment 1 Intervention

Each health system will consist of clinicians who are affiliated with primary care practices and patients who are eligible for CV primary prevention discussions. In the first step, health systems will be assigned to usual care (passive implementation of CV Prevention Choice).

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+