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

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: Completed
• Conditions: Cardiovascular Risk; Cardiovascular Prevention
• Intervention / Treatment: Behavioral: CV Prevention Choice Tool; Behavioral: Implementation Facilitation Strategies

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: Interventional
• Enrollment (Actual): 112127
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence 1; 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; 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: Sequence 2; 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; 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: Sequence 3; 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; 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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: The Predicted Marginal Probability of Statin Use is Concordant With Estimated Cardiovascular Risk	Patient risk-concordance was assessed using all of the patient's encounter level data. Statin prescription status was captured in the EHR up to 30 days after the encounter (i.e., the patient-clinician clinical visit) and their estimated 10-year risk of developing a first atherosclerotic cardiovascular disease (ASCVD) event, calculated using the Pooled Cohort Equation and data from the EHR including: age, race, total cholesterol, HDL cholesterol, systolic blood pressure, smoking status, diabetes status, and whether the individual is receiving treatment for high blood pressure (if systolic blood pressure is greater than 120 mmHg). Risk concordance was defined as having a statin prescription in groups where ASCVD risk was > or equal to 7.5% and not having a statin prescription if it was < 7.5%. The least square means, using the patient's encounter level data, provides a marginal probability of the proportion of patients that would have a statin prescription within the risk*arm/group.	Approximately 4 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jennifer Ridgeway, PhD, Mayo Clinic; Principal Investigator: Victor Montori, MD, Mayo Clinic

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20-002772; R01HL151662-01 (U.S. NIH Grant/Contract)

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