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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors and patients make decisions about preventing heart disease. It focuses on the CV Prevention Choice Tool, which helps patients and doctors understand and decide on preventive care options. The trial tests various Implementation Facilitation Strategies for this tool across three health systems to determine the most effective method. Suitable candidates for this trial include adults aged 40-75 who have not experienced a heart attack or stroke and are receiving preventive care at participating primary care practices. As an unphased trial, it offers patients the chance to contribute to innovative strategies for heart disease prevention.

What prior data suggests that this shared decision making tool is safe for cardiovascular prevention?

Research has shown that the CV Prevention Choice Tool estimates heart attack risk using a simple calculator and pictures. This tool poses minimal risk as it primarily involves information sharing and decision support, without directly affecting the body, leading to very few safety concerns.

Studies have also shown that Implementation Facilitation Strategies assist healthcare providers in adopting new practices. These strategies aim to enhance care delivery and do not involve medical procedures, resulting in a very low risk to patients.

Both approaches focus on improving decision-making and care practices. They do not involve medications or invasive procedures, making them safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Shared Decision Making Tools for Cardiovascular Prevention trial because it aims to enhance how doctors and patients make decisions about preventing heart disease. Unlike traditional methods where decisions might be more one-sided, this approach emphasizes collaboration, ensuring that patients are actively involved in their care. The CV Prevention Choice Tool stands out by offering tailored information that helps patients understand their risks and the benefits of prevention strategies. Additionally, the trial's phased implementation approach—moving from usual care to active and then maintenance implementation—allows for gradual adaptation and sustainability in real-world settings. This could lead to more personalized and effective prevention plans, potentially revolutionizing cardiovascular care.

What evidence suggests that the CV Prevention Choice Tool and Implementation Facilitation Strategies could be effective for cardiovascular prevention?

This trial will evaluate the effectiveness of the CV Prevention Choice Tool and Implementation Facilitation Strategies in cardiovascular prevention. Research has shown that the CV Prevention Choice Tool helps people understand their risk of heart disease. It uses a risk calculator to estimate a person's chance of having heart problems over the next 10 years and presents this information with easy-to-understand visuals. This tool aids in deciding the best ways to prevent heart disease, which can include lifestyle changes or medications.

In this trial, some health systems will use the CV Prevention Choice Tool, while others will implement facilitation strategies to improve adherence to prevention guidelines. Studies have found that certain strategies help healthcare providers better follow prevention guidelines, leading to improved patient outcomes. These tools and strategies are designed to make it easier for patients and doctors to make informed decisions to prevent heart disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer Ridgeway, PhD

Principal Investigator

Mayo Clinic

Victor Montori, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Health systems are assigned to usual care and then move into active implementation of the CV Prevention Choice tool

2 years

Multiple visits as per health system schedule

Maintenance

All health systems move to maintenance implementation to ensure the CV Prevention Choice tool is part of routine practice

1 year

Follow-up

Participants are monitored for the effectiveness and adoption of the SDM tool in routine practice

1 year

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. shareddecisions.mayoclinic.org shareddecisions.mayoclinic.org/cvpreventiondecisionaid/

Heart Health: A CV Prevention Choice Tool | Home This conversation aid will help you and your clinician discuss your risk of heart attack and how to manage it.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9530931/

The design and development of an encounter tool to support ... A U.S. multicenter trial is estimating the effectiveness of CV Prevention Choice in achieving risk-concordant CV prevention while ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335522003011

The design and development of an encounter tool to ... A U.S. multicenter trial is estimating the effectiveness of CV Prevention Choice in achieving risk-concordant CV prevention while identifying the best ...

4. reporter.nih.gov reporter.nih.gov/project-details/10611866

Project Details - NIH RePORTER An effective and innovative tool that estimates CV risk and shows the impact and features of available lifestyle and pharmacological preventive interventions ...

5. carethatfits.org carethatfits.org/2021/09/02/heart-health-a-cardiovascular-prevention-choice-tool/

Heart Health: A Cardiovascular Prevention Choice Tool This tool uses the ASCVD risk calculator to estimate the patient's 10-year ASCVD risk and a 100-person pictograph to display this risk. Then we ...

6. carethatfits.org carethatfits.org/cardiovascular-primary-prevention-choice/

Cardiovascular (CV)Prevention Choice The CV Prevention Choice tool will be integrated within electronic medical record systems and implemented in primary care settings.

7. professional.heart.org professional.heart.org/en/guidelines-and-statements/ascvd-risk-calculator

2018 Prevention Guidelines Tool CV Risk Calculator The purpose of the ASCVD Risk Calculator is to estimate a patient's 10-year ASCVD risk at an initial visit to establish a reference point.