NCT04450914

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112,127 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary prevention of cardiovascular (CV) events is often more intense in individuals at lower risk and vice versa (the so called "risk-treatment paradox") in part due to unawareness of each person's CV risk, of their preferences for prevention interventions, and of their feasibility in each person's daily life. Clinical practice guidelines recommend that clinicians and patients work together to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences, a process called shared decision making (SDM). Despite the availability of an innovative and effective tool that estimates CV risk, shows the impact and features of available lifestyle and pharmacological preventive interventions, and thus can facilitate CV treatment discussions between clinicians and patients, this type of SDM does not routinely happen in practice. The challenge therefore is to identify strategies to increase adoption of this type of SDM in real-world clinical practices. This 4-year study - proposed by a multidisciplinary team with expertise in preventive cardiology, SDM, and implementation science - aims to integrate an SDM tool (the CV Prevention Choice tool) in the primary care practices of three diverse health care systems in the U.S. and study both the tool and tailored strategies that foster its adoption and routine use. The study will use a mixed method, hybrid implementation-effectiveness (Type III) step-wedge clustered randomized trial design to determine: * Implementation effectiveness (Aim 1) by evaluating the settings (including local workflow and policies) in which the CV Prevention Choice tool is implemented and the engagement of users in implementation strategies; implementation outcomes (e.g., reach, adoption) associated with these strategies; and how implementation fosters routine adoption of SDM and the CV Prevention Choice tool in primary care practices, and * SDM effectiveness (Aim 2) estimated by the extent to which individual CV prevention plans are feasible and congruent with each person's estimated CV risk and preferences. The investigators hypothesize that efforts to assess local needs and use them to develop tailored implementation approaches will foster greater adoption of SDM in practice. They further hypothesize that individual preventive care plans will be congruent with estimated risk when clinicians adopt the SDM tool. The broad goal is to promote patient-centered care that effectively reduces the substantial burden of CV disease among Americans. By the project's end, the investigators expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care.

Conditions

• Cardiovascular Risk
• Cardiovascular Prevention

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-10
• Primary completion: 2024-12-31
• Completion: 2025-04-29
• First posted: 2020-06-30
• Last updated: 2025-05-02

Locations

4 sites across 1 country: United States