Washington University, the

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.