Integrated Smoking Cessation for Smokers With Serious Mental Illness: Protocol for a Convergent Mixed Methods Implementation Evaluation Study.

Background: Tobacco smoking is associated with significant morbidity and premature mortality in individuals with serious mental illness. A 2-year pragmatic clinical trial (PCORI PCS-1504-30472) that enrolled 1100 individuals with serious mental illness in the greater Boston area was conducted to test 2 interventions for tobacco cessation for individuals with serious mental illness: (1) academic detailing, which delivers education to primary care providers and highlights first-line pharmacotherapy for smoking cessation, and (2) provision of community health worker support to smoker participants. Implementing and scaling this intervention in other settings will require the systematic identification of barriers and facilitators, as well as the identification of relevant subgroups, effective and unique components, and setting-specific factors.

Objective: This protocol outlines the proposed mixed methods evaluation of the pragmatic clinical trial to (1) identify barriers and facilitators to effective implementation of the interventions, (2) examine group differences among primary care physicians, and (3) identify barriers that stakeholders such as clinical, payor, and policy leaders would anticipate to impact the implementation of effective components of the intervention.

Methods: Qualitative interviews will be conducted with all study community health workers and selected smoker participants, primary care providers, and other stakeholders. Measures of performance and engagement will guide purposive sampling. The Consolidated Framework for Implementation Research will guide qualitative data collection and analysis in accordance with the following framework approach: (1) familiarization, (2) identifying a thematic framework, (3) indexing, (4) charting, and (5) mapping and interpretation. Joint display analyses will be constructed to analyze and draw conclusions across the quantitative and qualitative data.

Results: The 3-year cluster-randomized trial has concluded, and the analysis of primary outcomes is underway. Results from the pragmatic trial and this mixed methods implementation evaluation will be used to help disseminate, scale, and expand a systems intervention.

Conclusions: The results of this mixed methods implementation evaluation will inform strategies for dissemination and solutions to potential barriers to the implementation of interventions from a smoking cessation trial for individuals with serious mental illness.

International Registered Report Identifier (irrid): DERR1-10.2196/25390.