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Abstract 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 Background Many healthcare organizations have developed disclosure policies for large-scale adverse events, including the Veterans Health Administration (VA). This study evaluated VA’s national large-scale disclosure policy and identifies gaps and successes in its implementation. Methods Semi-structured qualitative interviews were conducted with leaders, hospital employees, and patients at nine sites to elicit their perceptions of recent large-scale adverse events notifications and the national disclosure policy. Data were coded using the constructs of the Consolidated Framework for Implementation Research (CFIR). Results We conducted 97 interviews. Insights included how to handle the communication of large-scale disclosures through multiple levels of a large healthcare organization and manage ongoing communications about the event with employees. Of the 5 CFIR constructs and 26 sub-constructs assessed, seven were prominent in interviews. Leaders and employees specifically mentioned key problem areas involving 1) networks and communications during disclosure, 2) organizational culture, 3) engagement of external change agents during disclosure, and 4) a need for reflecting on and evaluating the policy implementation and disclosure itself. Patients shared 5) preferences for personal outreach by phone in place of the current use of certified letters. All interviewees discussed 6) issues with execution and 7) costs of the disclosure. Conclusions CFIR analysis reveals key problem areas that need to be addresses during disclosure, including: timely communication patterns throughout the organization, establishing a supportive culture prior to implementation, using patient-approved, effective communications strategies during disclosures; providing follow-up support for employees and patients, and sharing lessons learned.