Using Patient Incentive Payments to Reduce Smoking Associated Surgical Complications Following Lower Extremity Trauma: A Randomized Clinical Trial

PROJECT SUMMARY Over the past few decades, substantial evidence has accrued about the benefits and limitations of incentive- based smoking cessation interventions. These interventions appear to significantly increase quit rates in the short term, but these reductions are not sustained beyond the incentive payment period. These results have now been replicated in several large studies. In the orthopaedic trauma setting, however, the short-term cessation in smoking may provide a unique opportunity to improve patient outcomes. Infection, nonunion and soft tissue complications are likely the biggest clinical drivers of poor outcomes following orthopaedic trauma. There is a fair amount of consensus in the field that smoking roughly doubles the risk of these complications, and the vast majority of complications occur during the first six months following trauma. If smoking rates could be reduced during this critical period, it is possible that incentive-based smoking cessation interventions may significantly reduce complication rates. The proposed study aims to examine the effectiveness of a multi-pronged smoking and tobacco cessation intervention in combination with a patient incentive strategy in the reduction of complications following lower extremity trauma. The study is a randomized clinical trial (RCT) of two approaches: (a) best practice intervention (standard of care + inpatient face-to-face brief smoking counseling/motivational interviewing coupled with direct enrollment in a state-based, standardized smoking cessation support program) and (b) best practice intervention + patient incentives for smoking cessation. The goal of this proposed study is to provide definitive evidence regarding the effectiveness of patient incentives for orthopedic trauma patients in reducing complication rates and promoting smoking cessation. If successful, this cost effective and readily implemented approach can be made available to trauma patients nationwide. We believe the proposed intervention will support a paradigm shift in the care of patients across the orthopaedic trauma spectrum, significantly improving outcomes, morbidity and costs for this population. The primary outcome for this study will be a composite rate of major limb complication clearly linked to re- hospitalization, or same day surgery and associated with smoking and tobacco use in the orthopaedic literature: surgical site infection, nonunion, and wound dehiscence. In addition to the primary outcomes, several secondary outcomes will be tracked to test the hypothesis associated with the study specific aims: (1) Smoking cessation; (2) Participation in smoking cessation programs; (3) Patient Reported Outcome (PROs) and Quality of Life; (4) Clinical Outcomes Associated with Smoking Cessation; (5) Patient reported satisfaction with overall treatment; (6) Return to Usual Major Activity. The study will also aim to examine the dose response relationship between the amount of patient incentives, the rate of complications, and smoking cessation by implementing a randomized incentive architecture with five sub-samples of patients receiving payments of varying amounts.