Study method for a single-arm, multi-center implementation study of strategies for use by healthcare professionals in offering smokers an adapted proactive referral for online smoking cessation treatment in health check-up settings: a hybrid type 3 effectiveness-implementation study (N-EQUITY2405).

Introduction: Proactive referral, defined as a strategy to connect smokers with smoking cessation programs under the responsibility of healthcare professionals, is effective in increasing the uptake of such programs. A feasibility study in a health check-up setting of the Brief Tobacco Intervention with Proactive Referral (BTI-PR), our smoker-level implementation strategy for smoking cessation treatment (SCT), revealed that the BTI-PR could be delivered to 85.7% of smokers as intended by healthcare professionals following provider-level guidance on implementation, which included educational sessions and the provision of materials. The present study aimed to estimate smoker uptake of SCT following a multifaceted, provider-level implementation strategy in Japanese real-world health check-up settings. Methods: This single-arm, multi-center, uncontrolled hybrid type 3 effectiveness-implementation study is focused on providing stakeholders with the evidence necessary to support adoption of the BTI-PR together with its provider-level implementation strategy. The BTI-PR is a smoker-level implementation strategy for SCT which acts by motivating smokers to schedule an online SCT appointment by themselves. The provider-level implementation strategy consists of eight components: (a) conduct a training session, (b) provide a guide on the BTI-PR, (c) provide a checksheet for the BTI-PR, (d) provide a flyer on the online SCT, (e) conduct a kickoff meeting and request to discuss pre-specifiable matters, (f) schedule a pre-implementation phase, (g) request holding a review meeting and report, and (h) conduct a plenary meeting to share local knowledge. Primary outcome is the penetration of online SCT, namely the proportion of smokers eligible for the BTI-PR who attend the first session of the online SCT within 3 months after receiving the BTI-PR. Results: Data collection was completed in February 2026. A total of 24 healthcare professionals who received the provider-level implementation strategy delivered the BTI-PR to smokers to explore the primary outcome. The final analyses were commenced in March 2026. Conclusion: This study is expected to support the adoption of proactive referral together with an implementation strategy in health check-up settings, although causal inference remains limited. The findings will contribute to the implementation of effective smoking cessation support into preventive health services. Trial registration number: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064502; UMIN-CTR, number UMIN000056447.