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

April 30, 2025 updated by: Jennifer L. Ridgeway, Mayo Clinic
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health System
    • Virginia
      • Arlington, Virginia, United States, 22205
        • VHC Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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).
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.
Other: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reach metrics
Time Frame: Q1/Year 2 through Q3/Year 4
Proportion of eligible clinicians who accessed CV Prevention Choice (among all eligible clinicians), as indicated by EHR user metrics. Higher proportions indicate greater reach.
Q1/Year 2 through Q3/Year 4
Effectiveness perceptions
Time Frame: Q1/Year 2 through Q3/Year 4
Qualitative findings of the perceptions of tool effectiveness, as assessed through interviews and focus groups with eligible clinicians.
Q1/Year 2 through Q3/Year 4
Adoption metrics
Time Frame: Q1/Year 2 through Q3/Year 4
Proportion of eligible clinicians that used CV Prevention Choice in encounters identified in the EHR as being eligible for a CV preventive care discussion (among all eligible visits), as indicated by EHR user metrics. Higher proportions indicate greater adoption.
Q1/Year 2 through Q3/Year 4
Adoption perceptions
Time Frame: Q1/Year 2 through Q3/Year 4
Qualitative findings of reasons for adoption of or failure to adopt CV Prevention Choice, as assessed through interviews and focus groups with eligible clinicians.
Q1/Year 2 through Q3/Year 4
Implementation fidelity
Time Frame: Q1/Year 4 through Q3/Year 4
A sample of SDM clinical encounters will be audio-video recorded. Recordings will be reviewed and scored according to a five-point SDM fidelity checklist. Higher scores indicate greater fidelity to the core components of SDM.
Q1/Year 4 through Q3/Year 4
Implementation SDM quality
Time Frame: Q1/Year 4 through Q3/Year 4
Adherence to SDM quality will be assessed among a sample of patients with SDM clinical encounters using the Shared Decision Making Questionnaire (SDM-Q-9) questionnaire. Higher scores are indicative of higher levels of SDM occurring in the encounter. Range of scores is 0 to 100.
Q1/Year 4 through Q3/Year 4
Implementation care quality
Time Frame: Q1/Year 4 through Q3/Year 4
Care quality will be assessed among a sample of patients with SDM clinical encounters using the 10-item CARE Patient Feedback Measure. Higher scores are indicative of higher patient reported relational empathy in the consultation. Range of scores is 10 to 50.
Q1/Year 4 through Q3/Year 4
Maintenance metrics
Time Frame: Q1/Year 4 through Q3/Year 4
Change in CV PREVENTION CHOICE use, as indicated by EHR user metrics for eligible clinicians, at the start and end of the maintenance stage. Equivalent or higher use at the end of the maintenance stage indicates maintenance of the tool as part of routine practice.
Q1/Year 4 through Q3/Year 4
Maintenance self-report
Time Frame: Q1/Year 4 through Q3/Year 4
The NoMAD questionnaire will be administered to clinicians to assess normalization of CV Prevention Choice into practice. The NoMAD questionnaire is a continuous outcome converted to a 0-100 point scale, where higher scores indicate higher levels or normalization of CV Prevention Choice into routine care.
Q1/Year 4 through Q3/Year 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SDM Effectiveness
Time Frame: Q1/Year 2 through Q3/Year 4
The assessment of statin prescription post encounter of interest is congruent with the patient estimated CV Risk based off EHR data.
Q1/Year 2 through Q3/Year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Ridgeway, PhD, Mayo Clinic
  • Principal Investigator: Victor Montori, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-002772

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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