INTRODUCTION: The Implementation Research Logic Model (IRLM) is a key tool for guiding evidence-based health care implementation. However, multilevel interventions are inherently complex, making it challenging to distinguish the inter-relationships between clinical and implementation interventions. AIMS: To address this, we developed the Clinical, Service, and Implementation Intervention Research Logic Model (CSII-RLM) to support the co-design and implementation of ProCure, a database that supports clinicians with off-label therapy applications in pediatric precision medicine. METHODS: We deductively coded and analyzed a qualitative dataset using the Consolidated Framework for Implementation Research (CFIR), generated from 17 pediatric health care professional semi-structured interviews. We entered the synthesized data into the IRLM Clinical Intervention template and made adaptations to allow for a more comprehensive fit of the data, resulting in the CSII-RLM. We incorporated worked examples and developed algorithms to demonstrate application and functionality. RESULTS: The new intermediary "Service Intervention" successfully defined ProCure as a separate, supporting intervention within the broader context of pediatric precision medicine. Worked examples demonstrate how the CSII-RLM distinguishes between clinical and service-level interventions and helps to capture and understand real-world implementation. Novel algorithms further support the development and understanding of causal pathways for each intervention. CONCLUSIONS: The CSII-RLM is a promising tool that can assist the design and implementation of service interventions to support complex clinical interventions within the health care setting. The application of the CSII-RLM has been demonstrated in the implementation planning phase of ProCure and will continue to be tested and refined throughout its implementation. SPANISH ABSTRACT: http://links.lww.com/IJEBH/A582.
McKay et al. (Thu,) studied this question.