Contingency Management for Veteran Smokers Undergoing Elective Major Surgery: Protocol and Rationale for a Pilot Randomized Controlled Trial

Abstract Background Smoking is the leading risk factor for postoperative complications and is associated with longer hospital stays, reoperations, and 30-day mortality. Smoking rates among patients undergoing major elective surgery are high (22.3%‐43.0%). It is urgent to identify efficacious, strategically timed smoking cessation interventions for patients undergoing surgery. Objective The goal of this pilot randomized controlled trial is to design and test the feasibility of the first mobile contingency management (mCM) smoking-cessation intervention for military veterans undergoing major elective surgery and to evaluate the effectiveness of mCM compared to treatment as usual (TAU) as exploratory analysis. Methods We will adapt and adjust a contingency management protocol for delivery over 5 weeks using mobile carbon monoxide monitoring in the perioperative period. We will then test its feasibility and effectiveness in veteran smokers undergoing major elective surgery (n=36). Participants will be randomized to receive mCM or TAU. Both groups will receive pharmacotherapy. The feasibility of mCM will be assessed by (1) recruitment rate, (2) level of engagement, and (3) retention. We will also compare mCM with TAU on smoking cessation outcomes (quit attempts, cigarettes per day, and nicotine dependence severity) over 5 weeks to examine effectiveness. Results This pilot trial has been funded since July 2024, and a 1-year no-cost extension has been granted through June 2027. The recruitment and data collection started in December 2025. The first participant consented on December 12, 2026. As of May 2026, 18 participants have been enrolled and randomized in this pilot trial. Enrollment of the last participant is expected to be in March 2027 to reach a target of 36 enrolled participants, and the data collection is expected to be completed by April 2027. There will be no interim data analysis, but preliminary analysis is expected to be completed by August 2027, and all data analyses will be completed by the end of 2027. Conclusions Novel interventions to support smoking cessation may reduce morbidity, mortality, and health care costs for patients undergoing major surgery. mCM has a high potential to implement widely to improve surgical outcomes.