Abstract

BackgroundGuidelines recommend shared decision making (SDM) for determining whether to use statins to prevent cardiovascular events in at-risk patients. We sought to develop a toolkit to facilitate the cross-organizational spread and scale of a SDM intervention called the Statin Choice Conversation Aid (SCCA) by (i) assessing the work stakeholders must do to implement the tool; and (ii) orienting the resulting toolkit’s components to communicate and mitigate this work.MethodsWe conducted multi-level and mixed methods (survey, interview, observation, focus group) characterizations of the contexts of 3 health systems (n = 86, 84, and 26 primary care clinicians) as they pertained to the impending implementation of the SCCA. We merged the data within implementation outcome domains of feasibility, appropriateness, and acceptability. Using Normalization Process Theory, we then characterized and categorized the work stakeholders did to implement the tool. We used clinician surveys and IP address-based tracking to calculate SCCA usage over time and judged how stakeholder effort was allocated to influence outcomes at 6 and 18 months. After assessing the types and impact of the work, we developed a multi-component toolkit.ResultsAt baseline, the three contexts differed regarding feasibility, acceptability, and appropriateness of implementation. The work of adopting the tool was allocated across many strategies in complex and interdependent ways to optimize these domains. The two systems that allocated the work strategically had higher uptake (5.2 and 2.9 vs. 1.1 uses per clinician per month at 6 months; 3.8 and 2.1 vs. 0.4 at 18 months, respectively) than the system that did not. The resulting toolkit included context self-assessments intended to guide stakeholders in considering the early work of SCCA implementation; and webinars, EMR integration guides, video demonstrations, and an implementation team manual aimed at supporting this work.ConclusionsWe developed a multi-component toolkit for facilitating the scale-up and spread of a tool to promote SDM across clinical settings. The theory-based approach we employed aimed to distinguish systems primed for adoption and support the work they must do to achieve implementation. Our approach may have value in orienting the development of multi-component toolkits and other strategies aimed at facilitating the efficient scale up of interventions.Trial registrationClinicalTrials.govNCT02375815.

Highlights

  • Guidelines recommend shared decision making (SDM) for determining whether to use statins to prevent cardiovascular events in at-risk patients

  • The Statin Choice Conversation Aid (SCCA) was tested in several randomized trials [4,5,6,7] and most of the results suggested the conversation aid led to increased patient knowledge, greater patient comfort with the decision making process, and better alignment of prescription with estimated cardiovascular risk; one trial showed improvement in patient self-reported adherence to treatment at 3 months [4]

  • Assess Implementation context and readiness assessment Qualitatively, we found few clear distinctions between the Outer Settings or Individual Characteristics of the three systems, their Inner Settings differed in regards to organizational size, structure, maturity, culture, and capacity for collaboration, communication, and implementation

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Summary

Introduction

Guidelines recommend shared decision making (SDM) for determining whether to use statins to prevent cardiovascular events in at-risk patients. The SCCA was integrated into the Mayo Clinic electronic medical record (EMR) and made available for passive external dissemination on the Mayo Clinic Shared Decision Making National Resource Center website (statindecisionaid.mayoclinic.org) This passive dissemination had resulted in more than 166,000 hits on the website in 2016, but use of the tool from within the EMR remained limited to Mayo Clinic [8]; limited evidence of adoption by Mayo and other organizations existed [9]. The Centers for Medicare and Medicaid Services, in partnership with the Million Hearts initiative, started a demonstration project focused on using SDM for cardiovascular risk reduction [11] Together, this resulted in increased interest nationally in the routine use of SDM and other tools to support the decision to initiate statins for primary prevention

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