Developing a toolkit to implement the Statin Choice Conversation Aid at scale: application of a work reduction model

Abstract

Background Guidelines 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. Methods We 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. Results At 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. Conclusions We 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 registration ClinicalTrials.gov NCT02375815 . Electronic supplementary material The online version of this article (10.1186/s12913-019-4055-8) contains supplementary material, which is available to authorized users.

Overview of the main challenges in shared decision making in a multicultural and diverse society in the intensive and critical care setting

“…Although the health care context is complex and the variety of situation that can arise makes it impossible to prepare professionals for every occurrence: Organizations should try to create information packages for all the procedures where shared decision making is used as tool to aid the health care professional in communicating effectively all the relevant pieces of information to allow the patient or their next of kin to reach an informed decision. Leppin and colleagues have explored this approach with a toolkit to facilitate the cross‐organizational spread and scale of a shared decision making intervention called the Statin Choice Conversation Aid to support the recommended shared decision making approach in determining whether to use statins to prevent cardiovascular events in at‐risk patients . Training and capacity building, supported by specifically designed aids, in both health care professionals and patient has the potential to improve shared decision making and the patient‐reported quality of care .…”

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

“…The MCCN is a collaborative network linking more than 40 health systems around the globe with the research, education, and clinical expertise of Mayo Clinic. MCCN health systems have been involved in a variety of implementation-focused research studies and as such have served as a laboratory for exploring the challenges and opportunities of translating research into practice [ 22 , 33 , 34 ].…”

“…We assumed the following: (1) there will be > 400 evaluable patients per rollout in a health system during the study period (i.e., 1600 patients per health system with a total of 4800 encounters evaluable), (2) the intracluster correlation (ICC) is 0.10 with a between cluster variations of 0.025, and (3) a two-sided level of 0.05 for significance tests. Patient estimates are based on previous work to implement statin choice, where we saw a mean of 300 uses per month in each of three health systems [ 22 ]. Using methods for estimating sample size in a stepped wedge RCT [ 75 ], we estimate 97% power to detect the 10% increase in medications being recorded/prescribed in the EHR.…”

“…Integration of point-of-care SDM tools into the electronic health record (EHR) and associated workflows may support SDM but be insufficient for normalizing SDM into clinical routines [ 22 – 24 ]. Likewise, the availability of an SDM tool does not dictate fidelity to an SDM approach [ 25 ].…”

Envisioning Shared Decision Making: A Reflection for the Next Decade

“…Research studies that employed different approaches to disseminate point-of-care decision aids in varied clinical settings have yielded suboptimal results. 55-57 Could future implementation studies of SDM move beyond the implementation of SDM tools and, as in prior studies, integrate professional training and cultural interventions, 8,12,58,59 and, for example, promote choice awareness in the consultation, 57 or pursue multicomponent SDM interventions which combine tools, training, and patient engagement? 12 Shifts in mindset, system, and culture changes 60 to promote the space and time (mental, physical, emotional, and even spiritual) for important conversations could be compared to the sole incorporation of tools alone or with coaching.…”