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Background: Understanding how and when a new evidence-based clinical intervention becomes standard practice is crucial to ensure that healthcare is delivered in alignment with the most up-to-date knowledge. However, rigorous methods are needed to determine when a new clinical practice becomes normalized to the standard of care. To address this gap, this study qualitatively explores how, when, and why a clinical practice change becomes normalized within healthcare organizations. Methods: We used purposive sampling to recruit clinical leaders who worked in implementation science across diverse health contexts. Enrolled participants completed semi-structured interviews. Qualitative data analysis was guided by a modified version of the Normalization Process Theory (NPT) framework to identify salient themes. Identified normalization strategies were mapped to the Expert Recommendations for Implementation Change (ERIC) project. Results: A total of 17 individuals were interviewed. Participants described four key signals for identifying when a novel clinical practice becomes the new normal: 1) integration into existing workflows; 2) scaling across the entire organizational unit; 3) staff buy-in and ownership; and 4) sustainment without ongoing monitoring. Participants identified salient strategies to normalize new clinical interventions: 1) taking a patient approach; 2) gaining staff buy-in and ownership; and 3) conducting ongoing measurement of progress towards normalization. Conclusions: The results offer valuable insight into the indicators that signify when a novel clinical practice becomes normalized, and the strategies employed to facilitate this transition. These findings can inform future research to develop instruments that implementation leaders can use to systematically measure the clinical change process.
RESUMO
BACKGROUND: Although paternal involvement in the perinatal period is associated with benefits for maternal-child health and reduced obesity risk, fathers are seldom included in perinatal or obesity prevention efforts. Engaging community leaders and fathers as stakeholders in intervention development is a critical step in designing a father-inclusive intervention that is efficacious and responsive to their needs. METHODS: We conducted a structured engagement study, including community stakeholder engagement and qualitative interviews with new fathers, to inform the development of a prospective randomized controlled trial that includes mothers and fathers as equal partners in infant obesity prevention. We interpreted stakeholder feedback through the Consolidated Framework for Implementation Research (CFIR) framework. RESULTS: Between September 2019 and April 2020, we held a Community Engagement meeting, formed a Community Advisory Board, and conducted 16 qualitative interviews with new fathers. Stakeholder engagement revealed insights across CFIR domains including intervention characteristics (relative advantage, complexity, design quality & packaging), outer setting factors (cosmopolitanism and culture), individual characteristics (including self-efficacy, state of change, identification with the organization) and process (engagement and adaptation). Stakeholders discussed the diverse challenges and rewards of fatherhood, as well as the intrinsic paternal motivation to be a loving, supportive father and partner. Both community leaders and fathers emphasized the importance of tailoring program delivery and content to meet specific parental needs, including a focus on the social-emotional needs of new parents. CONCLUSIONS: A structured process of multidimensional stakeholder engagement was successful in improving the design of a father-inclusive perinatal obesity prevention interventions. Father engagement was instrumental in both reinforcing community ties and increasing our understanding of fathers' needs, resulting in improvements to program values, delivery strategies, personnel, and content. This study provides a practical approach for investigators looking to involve key stakeholders in the pre-implementation phase of intervention development. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04477577 . Registered 20 July 2020.
