CClinicalTrials.gg
CompletedNCT04450914SDM4IPUpdated Jul 29, 2026Results posted

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

An interventional study of CV Prevention Choice Tool and Implementation Facilitation Strategies in Cardiovascular Risk and Cardiovascular Prevention, sponsored by Mayo Clinic. Completed at 4 sites in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
112,127
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Risk
  • Cardiovascular Prevention
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
112,127 participants (actual)

Study arms

  • 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

  • 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 · Behavioral: Implementation Facilitation Strategies

  • 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

Interventions

  • BehavioralCV 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.

  • BehavioralImplementation 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 3.5 years

  2. 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.

    Time frame: Approximately 3.5 years

  3. 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.

    Time frame: Approximately 3.5 years

  4. 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.

    Time frame: Approximately 3.5 years

  5. 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.

    Time frame: Approximately 1 year

  6. 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.

    Time frame: Approximately 1 year

  7. 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.

    Time frame: Approximately 1 year

  8. 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.

    Time frame: Approximately 1 year

  9. 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.

    Time frame: Approximately 3 years

  10. 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.

    Time frame: Approximately 3 years

  11. 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.

    Time frame: Approximately 3 years

  12. 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.

    Time frame: Approximately 3 years

  13. 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.

    Time frame: Approximately 3 years

  14. 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.

    Time frame: Approximately 3 years

  15. 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.

    Time frame: Approximately 3 years

Secondary outcomes

  1. 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.

    Time frame: Approximately 4 years

07

Results

Posted Jul 29, 2026

Participant flow

From Q2/Year 2 though Q3/Year 5, participants and clinicians in three health systems were enrolled and had access to a shared decision making tool (CV Prevention Choice) to support patient-clinician conversations about cardiovascular risk. There was no individual consent at enrollment; electronic health record information from eligible encounters were included. Encounters are patient-clinician clinical visits.

Step 1 (Q2/Year 2 through Q1/Year 3)
Participant flow — Step 1 (Q2/Year 2 through Q1/Year 3)
MilestoneSequence 1Sequence 2Sequence 3
Started82351040022673
Clinicians533648
Patients81821036422625
Completed82351040022673
Not completed000
Step 2 (Q4/Year 2 through Q4/Year 4)
Participant flow — Step 2 (Q4/Year 2 through Q4/Year 4)
MilestoneSequence 1Sequence 2Sequence 3
Started165081752836599
Clinicians584958
Patients164501747936541
Completed165081752836599
Not completed000
Step 3 (Q4/Year 4 through Q3/Year 5)
Participant flow — Step 3 (Q4/Year 4 through Q3/Year 5)
MilestoneSequence 1Sequence 2Sequence 3
Started79681177022147
Clinicians393852
Patients79291173222095
Completed79681177022147
Not completed000

Outcome measures

PrimaryReach (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.

Time frame:
Approximately 3.5 years
Reported as:
Count of participants · Participants
Reach (RE-AIM): The Percentage of Clinicians Who Ever Used CV Prevention Choice
ParticipantsUsual CareActive ImplementationMaintenance
Reach (RE-AIM): The Percentage of Clinicians Who Ever Used CV Prevention Choice408754
Statistical analysis
  • Usual Care vs Active Implementation vs Maintenance · Chi-squared · p = 0.0002 (The a priori threshold for statistical signficance was \<0.05.)
PrimaryEffectiveness (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.

Time frame:
Approximately 3.5 years
Reported as:
Count of participants · Participants
Effectiveness (RE-AIM): Clinician Perceptions of CV Prevention Choice Effectiveness
ParticipantsUsual CareActive ImplementationMaintenance
CV Prevention Choice supports SDM2223
CV Prevention Choice does not support SDM015
Unsure if CV Prevention Choice supports SDM500
PrimaryAdoption (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.

Time frame:
Approximately 3.5 years
Reported as:
Count of participants · Participants
Adoption (RE-AIM): The Percentage of Clinicians Who Adopted CV Prevention Choice in Routine Care
ParticipantsUsual CareActive ImplementationMaintenance
Adoption (RE-AIM): The Percentage of Clinicians Who Adopted CV Prevention Choice in Routine Care286740
Statistical analysis
  • Usual Care vs Active Implementation vs Maintenance · Chi-squared · p = 0.005 (The a priori threshold for statistical signficance was \<0.05.)
PrimaryAdoption (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.

Time frame:
Approximately 3.5 years
Reported as:
Count of participants · Participants
Adoption (RE-AIM): Clinician Perceptions of CV Prevention Choice Adoption
ParticipantsUsual CareActive ImplementationMaintenance
Reasons for adopting3224
Reasons for not adoption414
PrimaryImplementation (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.

Time frame:
Approximately 1 year
Reported as:
Mean · score on a scale
Implementation (RE-AIM): Observer Scoring of Clinician Fidelity to Shared Decision Making Behaviors in Audio-video Recorded Encounters
score on a scaleUsual CareActive ImplementationMaintenance
Implementation (RE-AIM): Observer Scoring of Clinician Fidelity to Shared Decision Making Behaviors in Audio-video Recorded Encounters——0.67 ± 0.50
PrimaryImplementation (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.

Time frame:
Approximately 1 year
Reported as:
Mean · score on a scale
Implementation (RE-AIM): Average Patient-reported Rating of the Quality of Shared Decision Making After a Clinical Encounter
score on a scaleUsual CareActive ImplementationMaintenance
Implementation (RE-AIM): Average Patient-reported Rating of the Quality of Shared Decision Making After a Clinical Encounter——37.2 ± 7.9
PrimaryImplementation (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.

Time frame:
Approximately 1 year
Reported as:
Mean · score on a scale
Implementation (RE-AIM): Average Patient-reported Quality of Care After a Clinical Encounter
score on a scaleUsual CareActive ImplementationMaintenance
Implementation (RE-AIM): Average Patient-reported Quality of Care After a Clinical Encounter——49 ± 2.6
PrimaryMaintenance (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.

Time frame:
Approximately 1 year
Reported as:
Count of participants · Participants
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
ParticipantsUsual CareActive ImplementationMaintenance (First Two Months)Maintenance (Last Four Months)
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——4343
Statistical analysis
  • Maintenance (First Two Months) vs Maintenance (Last Four Months) · Chi-squared · p = 0.99 (The a priori threshold for statistical significance was \<0.05)
PrimaryMaintenance (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.

Time frame:
Approximately 3 years
Reported as:
Count of participants · Participants
Maintenance (RE-AIM): Clinician Self-reported Perception of How CV Prevention Choice Differs From Usual Ways of Working
ParticipantsUsual CareActive ImplementationMaintenance
Strongly disagree—01
Disagree—114
Neither agree nor disagree—1113
Agree—81
Strongly agree—20
Missing—21
Statistical analysis
  • Active Implementation vs Maintenance · Cochran-Armitage trend test · p = <.0001 (The a priori threshold for statistical significance was \<0.05)
PrimaryMaintenance (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.

Time frame:
Approximately 3 years
Reported as:
Count of participants · Participants
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether CV Prevention Choice Has Potential Value for Their Work
ParticipantsUsual CareActive ImplementationMaintenance
Strongly disagree—09
Disgree—313
Neither agree nor disagree—52
Agree—94
Strongly agree—61
Missing—11
Statistical analysis
  • Active Implementation vs Maintenance · Cochran-Armitage trend test · p = <0.0001 (The a priori threshold for statistical significance was \<0.05)
PrimaryMaintenance (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.

Time frame:
Approximately 3 years
Reported as:
Count of participants · Participants
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether There Are Key People to Drive CV Prevention Choice Forward and Get Others Involved
ParticipantsUsual CareActive ImplementationMaintenance
Strongly disagree—15
Disagree—215
Neither agree nor disagree—47
Agree—131
Strongly agree—31
Missing—11
Statistical analysis
  • Active Implementation vs Maintenance · Cochran-Armitage trend test · p = <.0001 (The a priori threshold for statistical significance was \<0.05)
PrimaryMaintenance (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.

Time frame:
Approximately 3 years
Reported as:
Count of participants · Participants
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether CV Prevention Choice Can be Easily Integrated Into Existing Work
ParticipantsUsual CareActive ImplementationMaintenance
Strongly disagree—310
Disagree—29
Neither agree nor disagree—73
Agree—55
Strongly agree—52
Missing—21
Statistical analysis
  • Active Implementation vs Maintenance · Cochran-Armitage trend test · p = 0.0753 (The a priori threshold for statistical significance was \<0.05)
PrimaryMaintenance (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.

Time frame:
Approximately 3 years
Reported as:
Count of participants · Participants
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether Sufficient Training Was Provided to Implement CV Prevention Choice
ParticipantsUsual CareActive ImplementationMaintenance
Strongly disagree—08
Disagree—79
Neither agree nor disagree—46
Agree—103
Strongly agree—12
Missing—22
Statistical analysis
  • Active Implementation vs Maintenance · Cochran-Armitage trend test · p = 0.0034 (The a priori threshold for statistical significance was \<0.05)
PrimaryMaintenance (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.

Time frame:
Approximately 3 years
Reported as:
Count of participants · Participants
Maintenance (RE-AIM): Clinician Self-reported Perception of Management Support for CV Prevention Choice
ParticipantsUsual CareActive ImplementationMaintenance
Strongly disagree—06
Disagree—59
Neither agree nor disagree—010
Agree—122
Strongly agree—51
Missing—22
Statistical analysis
  • Active Implementation vs Maintenance · Cochran-Armitage trend test · p = 0.0004 (The a priori threshold for statistical significance was \<0.05)
PrimaryMaintenance (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.

Time frame:
Approximately 3 years
Reported as:
Count of participants · Participants
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether Staff Agree CV Prevention Choice is Worthwhile
ParticipantsUsual CareActive ImplementationMaintenance
Strongly disagree—11
Disagree—17
Neither agree nor disagree—1017
Agree—83
Strongly agree—10
Missing—32
Statistical analysis
  • Active Implementation vs Maintenance · Cochran-Armitage trend test · p = 0.0281 (The a priori threshold for statistical significance was \<0.05)
SecondaryEffectiveness: 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.

Time frame:
Approximately 4 years
Reported as:
Least squares mean · Percent Probability
Effectiveness: The Predicted Marginal Probability of Statin Use is Concordant With Estimated Cardiovascular Risk
Percent ProbabilityUsual CareActive ImplementationMaintenance
Less than 7.5%32.2 (31.5 to 32.9)35.6 (34.9 to 36.2)36.1 (35.4 to 36.8)
7.5% to 19.9%43.9 (43.0 to 44.8)48.7 (47.9 to 49.5)52.2 (51.3 to 53.1)
20% to 29.9%53.1 (51.6 to 54.5)57.4 (56.4 to 58.4)60.9 (59.6 to 62.1)
30% or greater59.5 (57.5 to 61.5)64.1 (62.7 to 65.4)67.1 (65.4 to 68.8)
Statistical analysis
  • Usual Care vs Active Implementation vs Maintenance · Mixed Models Analysis · p = <0.001 (General Estimating Equation with repeated measure of patient encounters were assessed, reporting the chi-square test statistic for the interaction term the group/arm and risk categories, providing output at the patient level.)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sequence 1———
Sequence 2———
Sequence 3———

Baseline characteristics

Baseline demographic characteristics are reported for participants at the time of their initial enrollment, and participants were only included once. Baseline demographics were not collected for clinicians.

Age, Continuous
Age, Continuous(years)Sequence 1Sequence 2Sequence 3Total
Mean57.1 ± 9.8255.3 ± 10.5857.3 ± 10.0856.8 ± 10.19
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Sequence 1Sequence 2Sequence 3Total
Female10440121702523347843
Male8647101131909637856
Other or not reported0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Total
Hispanic or Latino370157420223966
Not Hispanic or Latino18507141014141574023
Unknown or Not Reported21066088927710
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Total
American Indian or Alaska Native5094259610
Asian273113513642772
Native Hawaiian or Other Pacific Islander10173158
Black or African American29922501011212661
White17629137312914360503
More than one race11348598957
Unknown or Not Reported356476030228138
Atherosclerotic Cardiovascular Disease (ASCVD) Risk
Atherosclerotic Cardiovascular Disease (ASCVD) Risk(Participants)Sequence 1Sequence 2Sequence 3Total
Less than 7.58538150592173045327
7.5 to 19.935804732905417366
20 to 29.956584617913202
30 or greater640416461175419804
08

Study locations

4 sites
  • Wellstar Health System
    Marietta, Georgia 30060, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Altru Health System
    Grand Forks, North Dakota 58201, United States
  • VHC Health
    Arlington, Virginia 22205, United States
09

References and documents

Publications

  • 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. PubMed 42218566 ↗
  • 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. PubMed 33883035 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 17, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04450914
Lead sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Jennifer L. Ridgeway (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jun 30, 2020
Start date
May 10, 2021
Primary completion
Dec 31, 2024
Completion
Apr 29, 2025
Results posted
Jul 29, 2026
Last update
Jul 29, 2026

Study contacts

Jennifer Ridgeway, PhD
principal investigator · Mayo Clinic
Victor Montori, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion