Adapting a workplace tobacco control program in small and medium-sized enterprises: identifying “key forms” for fidelity and flexibility using FRAME-IS

Background: Workplace smoking cessation programs remain underused in small and medium-sized enterprises (SMEs) due to limited resources and implementation barriers. interactive assistance via eHealth for SMEs' employers and healthcare manager teams on tobacco control (eSMART-TC), was developed to address this gap. Effective contextual adaptation is essential for optimizing implementation strategies in real-world settings. To address this, we analyzed how the eSMART-TC strategies were adapted to diverse workplace contexts, aiming to clarify which components were essential and which could be modified to maintain effectiveness. In doing so, we proposed and operationalized the concept of "Key forms"-strategy elements that should remain unchanged to ensure fidelity. This study applied the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) to systematically document and analyze these adaptations. Methods: This study analyzed data from the waitlist control group of the eSMART-TC cluster randomized controlled trial. Program delivery to the waitlist control group was designed to permit context-specific adaptations, with the condition that all adaptations be documented using the FRAME-IS framework. Data sources included provider checklists, discussion transcripts, employee surveys, and company-level evaluations. Adaptations were assessed using the Function and Forms Matrix to distinguish core functions from specific forms and to identify modifications necessary for optimization. Results: Of 26 identified forms supporting four core functions, 19 were classified as essential for maintaining fidelity. Seven forms, primarily involving session frequency and duration, were modified during implementation. These reactive yet context-sensitive changes aimed to meet organizational needs and improve feasibility. Provider discussions facilitated the identification of acceptable adaptations, underscoring the value of co-creation. Conclusion: The study protocol has been registered in the UMIN Clinical Trials Registry (UMIN-CTR; ID: UMIN000044526). Registered on 06/14/2021.