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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 .

Objective: Although the assistance of caregivers is critical to patients undertaking self-care, little is known about their participation in visits and involvement in decision making. We sought to examine this caregiver participation in shared decision making through videographic analysis., Methods: We identified video recordings from outpatient visits in which a healthcare professional, patient, and caregiver participated, drawn from five practice-based randomized trials testing the efficacy of decision aids vs. usual care. Two reviewers, working independently, coded videos to explore caregiver engagement in the clinical encounter, clinician facilitation of that engagement, and the influence of decision aids in the engagement process., Results: In most of the 37 videos coded, caregivers' participation was self-triggered. We saw no impact of the use of decision aids on caregiver participation. Clinicians did not address the caregivers' preferred level of involvement in decision making in any of the video recorded encounters analyzed., Conclusion: In this analysis, most clinicians did not engage caregivers in outpatient visits for chronic care. While the use of decision aids improves communication between patient and clinician, they do not appear to affect caregiver involvement during consultations., Practice Implications: Research on the comparative effectiveness of ways to engage caregivers to optimize patient-important outcomes, including enhancing the shared decision making process is necessary., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice., Methods/design: We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms., Discussion: Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices., Trial Registration: NCT00388050.