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Background: Shared Decision-Making to discuss how the benefits and harms of lung cancer screening align with patient values is required by the US Centers for Medicare and Medicaid and recommended by multiple organizations. Barriers at organizational, clinician, clinical encounter, and patient levels prevent SDM from meeting quality standards in routine practice. We developed an implementation plan, using the socio-ecological model, for Shared Decision-Making for lung cancer screening for the Department of Veterans Affairs (VA) New England Healthcare System. Because understanding the local context is critical to implementation success, we sought to proactively tailor our original implementation plan, to address barriers to achieving guideline-concordant lung cancer screening. Methods: We conducted a formative evaluation using an ethnographic approach to proactively identify barriers to Shared Decision-Making and tailor our implementation plan. Data consisted of qualitative interviews with leadership and clinicians from seven VA New England medical centers, regional meeting notes, and Shared Decision-Making scripts and documents used by providers. Tailoring was guided by the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Results: We tailored the original implementation plan to address barriers we identified at the organizational, clinician, clinical encounter, and patient levels. Overall, we removed two implementation strategies, added five strategies, and modified the content of two strategies. For example, at the clinician level, we learned that past personal and clinical experiences predisposed clinicians to focus on the benefits of lung cancer screening. To address this barrier, we modified the content of our original implementation strategy Make Training Dynamic to prompt providers to self-reflect about their screening beliefs and values, encouraging them to discuss both the benefits and potential harms of lung cancer screening. Conclusions: Formative evaluations can be used to proactively tailor implementation strategies to fit local contexts. We tailored our implementation plan to address unique barriers we identified, with the goal of improving implementation success. The FRAME-IS aided our team in thoughtfully addressing and modifying our original implementation plan. Others seeking to maximize the effectiveness of complex interventions may consider using a similar approach. [ABSTRACT FROM AUTHOR]

We provide practical guidance about using co-design methods to collaborate with patients to create patient-facing interventions, which others can use when undertaking similar projects. This is a narrative review synthesizing co-design principles and published literature with our experience working alongside five Veteran patients of the U.S. Department of Veterans Affairs in New England to co-design a portfolio of patient-facing materials to improve patient-centered care coordination. Our process took 12 weeks (April – June 2022) and was conducted entirely via video conference. Co-design is a participatory research method. Its principles include sharing power over the research process and products, agency for all participants, embracing a plurality of forms of knowledge, and mutual and reciprocal benefit. We describe three stages of the co-design process (preparatory work; design and development; feedback and closure), strategies and techniques we used at each stage, challenges we faced, and considerations for addressing them. Co-designing patient-facing interventions blends different forms of knowledge to produce practical, contextually specific interventions with ownership by the people who will use them. Co-design is a feasible methodology for most health services research teams whose goal is to intensify patient engagement in research. • Researchers are increasingly engaging patients as collaborators. • Co-design is a participatory methodology for patient engagement in research. • Its principles include shared ownership and respect for patients' knowledge. • We provide practical guidance for co-designing patient-facing interventions. [ABSTRACT FROM AUTHOR]