Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP)

Jennifer L Ridgeway,Emma M Behnken,Victor M Montori,Juan P Brito,Charanjit S Khurana,Aaron L Leppin,Nilay D Shah,Vivek Nautiyal,Victor D Torres Roldan,Devin M Mann,Yvonne L Gomez,Sandra A Hartasanchez,Derek Gravholt,Ian G Hargraves,Randal J Thomas,Megan E Branda

doi:10.1186/s43058-021-00145-6

Abstract

BackgroundThe primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person’s CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV Prevention Choice) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use.MethodsThis is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV Prevention Choice as well as normalization of CV Prevention Choice in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV Prevention Choice reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM).DiscussionBy the project’s end, we 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.Trial registrationClinicalTrials.gov, NCT04450914. Posted June 30, 2020Trial statusThis study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.

Highlights

The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa
We estimated the intervention effect that can be detected with our stepped wedge design on proportion of patients with a medication of interest on record to be detectable at a 10% increase over usual care with CV PREVENTION CHOICE
Effective, risk-concordant, and well-implemented preventive care in clinical practice is paramount to mitigate the effect that CV disease has on public and personal health

Summary

Introduction

The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. While public health interventions (e.g., smoking bans) are best suited to reduce the burden of CV disease in the population, clinical prevention can more precisely target high-risk individuals. A persistent finding in realworld evidence indicates most clinical interventions are implemented in people at relatively lower CV risk, and few among people at the highest risk [5, 6]. This socalled risk-treatment paradox has been observed repeatedly across a range of CV-risk reducing interventions such as statins and aspirin [5,6,7]. Black patients (vs. white), women (vs. men), and those covered by Medicare Advantage (vs. commercial insurance with identical formulary coverage) have been found to be less likely to receive these agents [8, 9]

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