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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2025-04-29

Brief Summary

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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.

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Detailed Description

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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

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Cardiovascular Risk Cardiovascular Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Mixed method, hybrid implementation-effectiveness (Type III) step-wedge clustered randomized trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Health Systems - First Step

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).

Group Type OTHER

CV Prevention Choice Tool

Intervention Type BEHAVIORAL

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.

Health Systems - Second Step

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 Type OTHER

CV Prevention Choice Tool

Intervention Type BEHAVIORAL

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.

Implementation Facilitation Strategies

Intervention Type BEHAVIORAL

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.

Health Systems - Third Step

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 Type OTHER

CV Prevention Choice Tool

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
* Patient Participants: Adult patients (ages 40-75 years) with or without diabetes who have not experienced an atherothrombotic clinical event and receive preventive care at a participating primary care practice will be eligible to participate.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No