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

利用患者奖励金减少下肢创伤后与吸烟相关的手术并发症：一项随机临床试验

• 批准号: 10581870
• 负责人: Renan C Castillo
• 金额: $ 24.16万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10581870
• 关键词: Adoption; Architecture; Clinical; Collaborations; Complication; Consensus; Counseling; Coupled; Data; Day Surgery; Dose; Effectiveness; Enrollment; Goals; Hospitals; Incentives; Infection; Infrastructure; Injury; Inpatients; Intervention; Limb structure; Link; Literature; Lower Extremity; Measurement; Measures; Orthopedics; Outcome; Outcome Study; Patient Outcomes Assessments; Patient Self-Report; Patient-Focused Outcomes; Patients; Population; Public Health Schools; Quality of life; Randomized; Recovery; Reporting; Research; Research Design; Risk; Risk Factors; Sampling Studies; Smoking; Smoking Cessation Intervention; Standardization; Surgical Wound Infection; Surgical complication; Testing; Tobacco Use Cessation; Tobacco use; Trauma; Trauma Research; Trauma patient; Urine; cost; cost effective; critical period; data standards; design; disability; effectiveness evaluation; experience; follow-up; functional outcomes; future implementation; hospital readmission; improved; incentive strategies; injured; inpatient service; limb injury; motivational enhancement therapy; novel; payment; primary outcome; programs; randomized, clinical trials; response; satisfaction; scale up; secondary outcome; smoking cessation; soft tissue; standard of care; tobacco cessation intervention; trauma centers; wound

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.

项目摘要 在过去的几十年里，大量的证据已经积累了关于激励的好处和局限性- 基于戒烟干预。这些干预措施似乎显着增加戒烟率， 短期内，但这些减少不会持续超过奖励支付期。这些结果 现在已经在几项大型研究中得到了复制。然而，在骨科创伤环境中， 戒烟可以提供改善患者结果的独特机会。感染、骨不连和 软组织并发症可能是骨科创伤后不良结局的最大临床驱动因素。 在该领域有相当多的共识，吸烟大约使这些并发症的风险增加一倍， 并且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 在这个关键时期减少，基于激励的戒烟干预措施可能会 显著降低并发症发生率。 这项拟议的研究旨在研究多管齐下的戒烟和戒烟的有效性 干预与患者激励策略相结合，以减少低血糖后并发症 四肢创伤该研究是一项随机临床试验（RCT），采用两种方法：（a）最佳实践 干预（护理标准+住院患者面对面简短的吸烟咨询/动机访谈 再加上直接参加以州为基础的标准化戒烟支持计划）和（B）最好 实践干预+患者戒烟激励。这项研究的目的是提供 关于骨科创伤患者的患者激励措施在减少 并发症率和促进戒烟。如果成功，这种做法具有成本效益，而且易于实施 可以向全国的创伤患者提供这种方法。 本研究的主要结局是与再手术明显相关的主要肢体并发症的复合发生率。 住院，或当天手术，并与吸烟和烟草使用的骨科 文献：手术部位感染、骨不连和伤口裂开。除了主要结果外， 将跟踪几个次要结局，以检验与研究特定目的相关的假设：（1） 戒烟;（2）参与戒烟计划;（3）患者报告结局（PRO） 和生活质量;（4）与戒烟相关的临床结局;（5）患者报告的满意度 （6）恢复日常主要活动。 该研究还旨在检查患者激励量之间的剂量反应关系， 并发症的发生率和戒烟，通过实施一个随机激励架构， 接受不同金额付款的患者的子样本。