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

NCT04450914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112127

Last updated 2025-05-02

No results posted yet for this study

Summary

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.

Conditions

  • Cardiovascular Risk
  • Cardiovascular Prevention

Interventions

BEHAVIORAL

CV Prevention Choice Tool

The CV Prevention Choice SDM tool is a shared decision making intervention. It is embedded in the electronic health record and uses EHR data to estimate and display cardiovascular risk for individual patients and then foster conversations between clinicians and patients about available options for preventive care based on individual risk and preferences.

BEHAVIORAL

Implementation Facilitation Strategies

During the active implementation stage, health systems will deploy tailored implementation facilitation and other tailored implementation strategies aimed at increasing adoption and use of shared decision making using CV Prevention Choice.

Sponsors & Collaborators

Principal Investigators

  • Jennifer Ridgeway, PhD · Mayo Clinic

  • Victor Montori, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2024-12-31
Completion
2025-04-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450914 on ClinicalTrials.gov