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

NCT04450914 | Completed Results

• 2 other identifiers: 20-002772R01HL151662-01
• 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 (15)

• Reach (RE-AIM): The Percentage of Clinicians Who Ever Used CV Prevention Choice

  Percentage of clinicians who used CV Prevention Choice, among all eligible clinicians in participating settings. Clinicians were eligible if they had at least one encounter during the period evaluated. Utilization was recorded in the electronic health record. Higher percentages indicate greater intervention reach.

  Approximately 3.5 years

• Effectiveness (RE-AIM): Clinician Perceptions of CV Prevention Choice Effectiveness

  Perceptions of CV Prevention Choice effectiveness, including whether it helps support shared decision making conversations, as assessed through interviews with eligible clinicians. Participant counts reflect the number of interview participants in the arm/group who indicated CV Prevention Choice supports shared decision making, does not support shared decision making, or were unsure whether it supported shared decision making.

  Approximately 3.5 years

• Adoption (RE-AIM): The Percentage of Clinicians Who Adopted CV Prevention Choice in Routine Care

  Percentage of eligible clinicians that used CV Prevention Choice in encounters identified in the electronic health record as a visit for preventive care (visit reason listed as annual exam or annual wellness visit), among all eligible preventive care encounters. Utilization was recorded in the electronic health record. Higher percentages indicate greater adoption.

  Approximately 3.5 years

• Adoption (RE-AIM): Clinician Perceptions of CV Prevention Choice Adoption

  Perceptions of CV Prevention Choice adoption, including reasons for adopting it or failing to adopt it in routine care, as assessed through interviews with eligible clinicians. Participant counts reflect the number of interview participants in the arm/group who gave reasons for adopting or not adopting CV Prevention Choice.

  Approximately 3.5 years

• Implementation (RE-AIM): Observer Scoring of Clinician Fidelity to Shared Decision Making Behaviors in Audio-video Recorded Encounters

  A sample of clinical encounters were audio-video recorded, reviewed by trained study staff, and scored using a fidelity checklist with 10 items indicating shared decision making behaviors. Each item was scored on a on a scale from -1=Behavior was undermined by comment or action to 4=The behavior is exhibited to a very high standard. An overall average score ranging from -1 to 4 was created by averaging the 10 item scores. A higher mean score indicates greater fidelity to the core components of shared decision making.

  Approximately 1 year

• Implementation (RE-AIM): Average Patient-reported Rating of the Quality of Shared Decision Making After a Clinical Encounter

  The quality of shared decision making was assessed using the Shared Decision Making Questionnaire (SDM-Q-9), which is a patient self-report measure designed to measure the extent and quality of shared decision making in a clinical encounter from the patient perspective. The nine items are scored on a 6-point Likert scale from 1 (Completely Disagree) to 6 (Completely Agree). Scores are summed and transformed to a 0-100 scale, with higher scores indicating greater perceived involvement in decision-making.

  Approximately 1 year

• Implementation (RE-AIM): Average Patient-reported Quality of Care After a Clinical Encounter

  The quality of care was assessed using the 10-item Consultation and Relational Empathy (CARE) Measure, which is a patient-reported measure of the experience of care in a clinical encounter. Higher scores are indicative of higher patient reported relational empathy in the consultation. Items are scored from 1 (Poor) to 5 (Excellent) and summed for a range of scores from 10 to 50. Higher scores indicate more positive assessment of care processes.

  Approximately 1 year

• Maintenance (RE-AIM): The Percentage of Clinicians Using CV Prevention Choice at the End of the Maintenance Period Compared to the Beginning of the Period

  The percentage of clinicians using CV Prevention Choice, as indicated in the electronic health record, at the transition to the maintenance period was compared to the percentage in the last two months of the maintenance phase. Equivalent or higher percentage use at the end of the maintenance stage indicates maintenance of the tool as part of routine practice.

  Approximately 1 year

• Maintenance (RE-AIM): Clinician Self-reported Perception of How CV Prevention Choice Differs From Usual Ways of Working

  Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "I can see how it differs from usual ways of working" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.

  Approximately 3 years

• Maintenance (RE-AIM): Clinician Self-reported Perception of Whether CV Prevention Choice Has Potential Value for Their Work

  Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "I can see the potential value of it for my own work" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.

  Approximately 3 years

• Maintenance (RE-AIM): Clinician Self-reported Perception of Whether There Are Key People to Drive CV Prevention Choice Forward and Get Others Involved

  Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "There are key people who drive it forward and get others involved" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.

  Approximately 3 years

• Maintenance (RE-AIM): Clinician Self-reported Perception of Whether CV Prevention Choice Can be Easily Integrated Into Existing Work

  Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "I can easily integrate it into my existing work" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.

  Approximately 3 years

• Maintenance (RE-AIM): Clinician Self-reported Perception of Whether Sufficient Training Was Provided to Implement CV Prevention Choice

  Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "Sufficient training is provided to enable staff to implement it" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.

  Approximately 3 years

• Maintenance (RE-AIM): Clinician Self-reported Perception of Management Support for CV Prevention Choice

  Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "Management adequately supports it" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.

  Approximately 3 years

• Maintenance (RE-AIM): Clinician Self-reported Perception of Whether Staff Agree CV Prevention Choice is Worthwhile

  Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "The staff agree that it is worthwhile" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.

  Approximately 3 years

Secondary Outcomes (1)

• Effectiveness: The Predicted Marginal Probability of Statin Use is Concordant With Estimated Cardiovascular Risk

  Approximately 4 years

Study Arms (3)

Sequence 1

OTHER

Sequence 1 began usual care (Step 1) on 9/24/2021, entered the active implementation period (Step 2) on 3/24/2022, and entered the maintenance period (Step 3) on 4/1/2024. In usual care, clinicans had access to CV Prevention Choice in their electronic health record but there were no other active implementation strategies deployed (passive implementation). The active implementation period included deployment of tailored implementaiton strategies. In the maintenance period, active implementation support ended but clinicians still had access to CV Prevention Choice in the EHR

Behavioral: CV Prevention Choice Tool

Sequence 2

OTHER

Sequence 2 began usual care (Step 1) on 4/13/2022, entered the active implementation period (Step 2) on 10/14/2022, and entered the maintenance period (Step 3) on 4/1/2024. In usual care, clinicans had access to CV Prevention Choice in their electronic health record but there were no other active implementation strategies deployed (passive implementation). The active implementation period included deployment of tailored implementaiton strategies. In the maintenance period, active implementation support ended but clinicians still had access to CV Prevention Choice in the EHR.

Behavioral: CV Prevention Choice Tool; Behavioral: Implementation Facilitation Strategies

Sequence 3

OTHER

Sequence 3 began usual care (Step 1) on 6/13/2022, entered the active implementation period (Step 2) on 12/13/2022, and entered the maintenance period (Step 3) on 4/1/2024. In usual care, clinicans had access to CV Prevention Choice in their electronic health record but there were no other active implementation strategies deployed (passive implementation). The active implementation period included deployment of tailored implementaiton strategies. In the maintenance period, active implementation support ended but clinicians still had access to CV Prevention Choice in the EHR.

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.

Sequence 1; Sequence 2; Sequence 3

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.

Sequence 2

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
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

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 (2)

• Ridgeway JL, Branda ME, Bagewadi S, Montori V, Jackson H, Nautiyal V, Dagoberg A, Gomez YL, Gharai H, Khurana CS, Louks K, Gravholt DL, Montori VM. Champions and early adopters in an implementation-effectiveness study of shared decision making: implications for interpersonal strategies. Implement Sci Commun. 2026 May 30. doi: 10.1186/s43058-026-00977-0. Online ahead of print.

  PMID: 42218566 DERIVED

• 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

Results Point of Contact

• Title: Dr. Ridgeway
• Organization: Mayo Clinic

ridgeway.jennifer@mayo.edu

5072844993

Study Officials

• Jennifer Ridgeway, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Victor Montori, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: July 29, 2026
• Results First Posted: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)