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Shared Decision Making Tools for Cardiovascular Prevention (SDM4IP Trial)

N/A

Waitlist Available

Led By Jennifer Ridgeway, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up q1/year 4 through q3/year 4

Awards & highlights

SDM4IP Trial Summary

This trial found that a CV prevention tool, when used in routine care, helped reduce risk blindness and lack of fit of the preventive regimen.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves decision-making tools rather than medications, traditional side effects aren't expected. However, there may be indirect effects on patients' stress levels due to discussions about their cardiovascular risks.

SDM4IP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ q1/year 4 through q3/year 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~q1/year 4 through q3/year 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and q1/year 4 through q3/year 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adoption metrics

Adoption perceptions

Effectiveness perceptions

+6 more

Secondary outcome measures

SDM Effectiveness

SDM4IP Trial Design

3Treatment groups

Experimental Treatment

Group I: Health Systems - Third StepExperimental Treatment1 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 StepExperimental Treatment2 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 StepExperimental Treatment1 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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,762,284 Total Patients Enrolled

2 Trials studying Cardiovascular Risk

350 Patients Enrolled for Cardiovascular Risk

Jennifer Ridgeway, PhDPrincipal InvestigatorMayo Clinic

Victor Montori, MDPrincipal InvestigatorMayo Clinic

6 Previous Clinical Trials

1,479 Total Patients Enrolled

1 Trials studying Cardiovascular Risk

313 Patients Enrolled for Cardiovascular Risk

Media Library

Health Systems - First Step Clinical Trial Eligibility Overview. Trial Name: NCT04450914 — N/A

Cardiovascular Risk Research Study Groups: Health Systems - First Step, Health Systems - Second Step, Health Systems - Third Step

Cardiovascular Risk Clinical Trial 2023: Health Systems - First Step Highlights & Side Effects. Trial Name: NCT04450914 — N/A

Health Systems - First Step 2023 Treatment Timeline for Medical Study. Trial Name: NCT04450914 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must one meet to join this medical trial?

"This medical trial is recruiting 4800 people between 40 and 75 years old with a history of cardiovascular risk. In order to be eligible, patients must have not experienced an atherothrombotic clinical event and receive preventative care at one of the participating primary care practices; while clinicians affiliated with those practices that tend to adult patients suitable for CV prevention will also take part in this research initiative."

Answered by AI

Is this experiment available to individuals aged 35 and above?

"Individuals aged 40-75 are eligible to participate in this clinical trial."

Answered by AI

Is there still an opportunity for individuals to enroll in this clinical trial?

"According to clinicaltrials.gov, this trial has concluded its recruitment process and is no longer actively seeking participants; however, there are currently 82 other trials that remain open for enrollment. This particular study was originally posted on May 10th 2021 and last modified September 3rd 2022."

Answered by AI

How many research centers are participating in this experiment?

"This trial is available in a total of 5 sites, such as Grand Forks, Rochester and Marietta. Participants are encouraged to select the nearest location to decrease their commute time if they decide to join this experiment."

Answered by AI

Recent research and studies

Implementation Science CommunicationsJournal

Increasing Risk-concordant Cardiovascular Care in Diverse Health Systems: A Mixed Methods Pragmatic Stepped Wedge Cluster Randomized Implementation Trial of Shared Decision Making (SDM4IP)

Ridgeway, Jennifer L., Megan E. Branda, Derek Gravholt, Juan P. Brito, Ian G. Hargraves, Sandra A. Hartasanchez, Aaron L. Leppin, et al.. 2021. “Increasing Risk-concordant Cardiovascular Care in Diverse Health Systems: A Mixed Methods Pragmatic Stepped Wedge Cluster Randomized Implementation Trial of Shared Decision Making (SDM4IP)”. Implementation Science Communications. Springer Science and Business Media LLC. doi:10.1186/s43058-021-00145-6.

clinicaltrials.govStudy

Implementing Shared Decision Making (SDM) For Individualized CV Prevention (SDM4IP)

Jennifer L. Ridgeway 2021. "Implementing Shared Decision Making (SDM) For Individualized CV Prevention (SDM4IP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04450914.