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.
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.
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.
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.
Wellstar Health System
Marietta, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Altru Health System
Grand Forks, North Dakota, United States
VHC Health
Arlington, Virginia, United States
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
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
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
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
Implementation (RE-AIM): Observer Scoring of Clinician Fidelity to Shared Decision Making Behaviors in Audio-video Recorded Encounters
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
112,127
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
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
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
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
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
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
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
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
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
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
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
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