Implementation science to scale and sustain tobacco treatment leveraging point of care paradigm and health information technology - we propose to evaluate scale-up and sustainment strategies to…

The National Cancer Institute (NCI) awarded Washington University a $1,594,797 Cooperative Agreement on September 4, 2025, under the 21st Century Cures Act - Beau Biden Cancer Moonshot program (CFDA 93.353) to conduct implementation science research evaluating scale-up and sustainment strategies for tobacco use treatment (TUT) in cancer survivors. The project, titled "Implementation Science to Scale and Sustain Tobacco Treatment Leveraging Point of Care Paradigm and Health Information Technology" (IMPACT), will deliver a rigorous two-phase study examining how implementation strategies and clinical context influence the successful adoption and sustainability of tobacco treatment programs across diverse cancer care settings. The award period extends through August 31, 2027.

The cooperative agreement funds a research initiative structured in two phases: a UG3 planning phase (years 1-2) focused on establishing feasibility and refining implementation strategies across four regional hubs, followed by a projected UH3 phase implementing a cluster-randomized controlled trial across 72 cancer clinics. The project leverages the Practical, Robust Implementation and Sustainability Model (PRISM) framework to identify contextual needs, harmonize outcomes, and test comparative implementation strategies. Sub-awardees include Vanderbilt University Medical Center (site PI Dr. Hilary Tindle), the University of Pennsylvania (site PI Dr. Robert Schnoll), and the Veteran Research and Education Foundation of St. Louis (site PI Dr. Theodore Thomas), each contributing clinical expertise, electronic health record data harmonization, and research staff to evaluate tobacco treatment reach, strategy fidelity, and implementation outcomes across diverse patient populations and clinic settings.

Implementation science to scale and sustain tobacco treatment leveraging point of care paradigm and health information technology - we propose to evaluate scale-up and sustainment strategies to promote tobacco use treatment (TUT) in cancer survivors. In a landmark study of 28 cancer centers, we learned that scale-up success is a function of both implementation strategies and clinical context. Clinic selection of implementation strategies varies, and the same strategies do not yield consistent outcomes across variable contexts. We need a rigorous comparison of commonly used strategies, knowledge on how context (and context-strategy fit) impacts scale-up and sustainment, and how to enhance scale-up and sustainment with additional strategies. In the UG3 phase, we will leverage the practical, robust implementation and sustainability model (prism), a context-based extension of the reach, effectiveness, adoption, implementation, maintenance (RE-aim) framework, to adapt/refine strategies, harmonize outcomes, and establish trial feasibility across a range of clinic settings. UG3 phase: aim 1: engage clinics using multilevel prism to identify contextual needs, core functions, and forms of strategies to scale-up and sustain TUT in a common protocol for use in the UH3. Aim 2: establish the feasibility of a multi-stage RCT by demonstrating fidelity of strategy components, harmonized outcome availability, and refined thresholds for the successful reach of TUT. Go/no-go threshold: to proceed to the UH3 phase, we must achieve >80% strategy fidelity, >80% outcome availability, and >15% TUT reach (based on empirical C3I data). UH3 phase: using a type 3 effectiveness-implementation hybrid design, we will test strategies in a 2-stage cluster-randomized smart trial of 72 clinics across 4 regional hubs. Stage 1 is a 4-arm cluster RCT to assess scale-up strategies. In stage 2, non-responder clinics will proceed to a 2-arm cluster RCT to compare scale enhancement strategies. Responder clinics will undergo a 2-arm cluster RCT to compare sustainment strategies. Aim 3: assess the effect of scale-up strategies on TUT reach and effectiveness. We hypothesize that referral to specialist, point of care, and combination will result in higher reach and effectiveness, compared to usual care. In a sub-aim, we will evaluate scale enhancement in non-responder clinics and hypothesize precision implementation (PI)+biological precision treatment (BPT) will result in higher TUT reach, compared to PI alone. Aim 4: test the effect of sustainment strategies on the maintenance of strategy component delivery, TUT reach, and effectiveness. We hypothesize that a clinic data-driven facilitation strategy (precision facilitation) will result in higher maintenance outcomes than general facilitation. Aim 5. Examine implementation outcomes and determinants associated with comparative strategies. This proposal will develop a contextually-informed algorithm for cancer clinics in selecting optimal implementation strategies for TUT and advance implementation science in refining the strategy-context fit and metrics to inform precision efforts to scale-up and sustain TUT for cancer survivors.