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

NCT04450914 | Completed

• 1 other identifier: 20-002772
• Study Type: interventional
• Target: 112,127
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (9)

• Reach metrics

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• SDM Effectiveness

  Q1/Year 2 through Q3/Year 4

Study Arms (3)

Health Systems - First Step

OTHER

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

Health Systems - Second Step

OTHER

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; Behavioral: Implementation Facilitation Strategies

Health Systems - Third Step

OTHER

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

Interventions

CV Prevention Choice Tool 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 - First Step; Health Systems - Second Step; Health Systems - Third Step

Implementation Facilitation Strategies 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 - Second Step

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (4)

Wellstar Health System

Marietta, Georgia, 30060, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Altru Health System

Grand Forks, North Dakota, 58201, United States

Location

VHC Health

Arlington, Virginia, 22205, United States

Location

Related Publications (1)

• Ridgeway JL, Branda ME, Gravholt D, Brito JP, Hargraves IG, Hartasanchez SA, Leppin AL, Gomez YL, Mann DM, Nautiyal V, Thomas RJ, Behnken EM, Torres Roldan VD, Shah ND, Khurana CS, Montori VM. Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP). Implement Sci Commun. 2021 Apr 21;2(1):43. doi: 10.1186/s43058-021-00145-6.

  PMID: 33883035 DERIVED

Study Officials

• Jennifer Ridgeway, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Victor Montori, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 30, 2020
• Study Start: May 10, 2021
• Primary Completion: December 31, 2024
• Study Completion: April 29, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)