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

项目总结 在过去的几十年里，关于激励的好处和局限性的大量证据已经积累起来- 以戒烟干预为基础。这些干预措施似乎显著提高了戒烟率。 短期内，但这些削减不会持续到奖励支付期之后。这些结果产生了 现在已经在几项大型研究中得到了重复。然而，在骨科创伤环境中，短期内 戒烟可能会提供一个独特的机会来改善患者的预后。感染、骨不连和 软组织并发症可能是骨科创伤后预后不佳的最大临床驱动因素。 这一领域有相当多的共识，即吸烟大致会使这些并发症的风险增加一倍， 绝大多数并发症发生在创伤后的前六个月。如果吸烟率可以 在这一关键时期，基于激励的戒烟干预措施可能会减少 显著降低并发症发生率。 这项拟议的研究旨在检查多管齐下的吸烟和戒烟的有效性。 干预结合患者激励策略减少低血压患者术后并发症 四肢创伤。该研究是两种方法的随机临床试验(RCT)：(A)最佳实践 干预(护理标准住院患者面对面简短吸烟咨询/激励性访谈 加上直接参加以州为基础的标准化戒烟支持计划)和(B)最佳 实践干预：鼓励患者戒烟。这项拟议研究的目标是提供 患者激励对骨科创伤患者减少创伤的有效性的明确证据 并发症发生率和促进戒烟。如果成功，这将具有成本效益并易于实施 可以在全国范围内向创伤患者提供这种方法。 这项研究的主要结果将是主要肢体并发症的综合比率明显与再发 住院或同日手术与骨科吸烟和烟草使用有关 文献：手术部位感染、骨不连和伤口裂开。除了主要结果外， 将跟踪几个次要结果，以检验与研究特定目标相关的假设：(1) 戒烟；(2)参与戒烟计划；(3)患者报告结果(PRO) 和生活质量；(4)与戒烟相关的临床结果；(5)患者报告的满意度 综合治疗；(6)恢复正常的主要活动。 这项研究还将旨在检查患者激励措施的数量之间的剂量反应关系， 通过实施随机激励架构来降低并发症发生率和戒烟 接受不同金额付款的患者的亚样本。

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. 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.