Project 2 - Translational Clinic

项目 2 - 转化诊所

• 批准号: 9754092
• 负责人: James M Davis
• 金额: $ 37.77万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9754092
• 关键词: Abstinence; Affect; Algorithmic Analysis; Algorithms; Animals; Behavior Therapy; Biochemical; Bupropion; Clinic; Clinical; Clinical Trials; Comorbidity; Costs and Benefits; Crossover Design; Cues; Data; Dependence; Development; Economics; Electronic cigarette; Elements; Enrollment; Funding; Future; Generations; Health system; Healthcare Systems; Human; Infrastructure; Instruction; Insurance; Investigation; Low income; Medical Students; Nicotine; Nicotine Dependence; Observational Study; Outcome; Outcome Study; Patch Tests; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacotherapy; Positioning Attribute; Postdoctoral Fellow; Program Sustainability; Randomized; Research; Site; Smoker; Smoking; Telephone; Testing; Translating; Translational Research; Treatment Efficacy; Universities; Visit; arm; base; cigarette addiction; clinical practice; comparative; cost; design; disorder later incidence prevention; distress tolerance; doctoral student; educational atmosphere; follow-up; graduate student; medication compliance; medication nonadherence; nicotine replacement; operation; programs; prospective; psychologic; recruit; response; smoking cessation; treatment arm; treatment group; treatment optimization; treatment strategy; varenicline

The overarching aim of Project-2 is the completion of an observational study (n = 3000) designed to test the P50-developed adaptive pharmacotherapy algorithm within the “Translational Smoking Cessation Program” (TSCP). During the past four years of P50 funding we have developed a pharmacotherapy “Algorithm” that uses response to nicotine “Test-Patch,” together with dependence testing, to allocate smokers to specific pharmacotherapies. Aim 1. The study will randomize 30 Duke University clinics participating in the Translational Smoking Cessation Program (TSCP) to Algorithm-based pharmacotherapy or Varenicline. After recruitment of 1500 (50%) subjects, the randomization status of clinics will be reversed (crossover design), allowing for control of both clinic effects and order effects. We hypothesize 1) that smokers treated in the TSCP with Algorithm-based pharmacotherapy vs. Varenicline will show significantly higher biochemically confirmed 12-week post-quit 30-day continuous abstinence (primary study outcome), and 2) that Algorithm-based pharmacotherapy compared to Varenicline will show significantly higher self-reported abstinence at 26- and 52-week post-quit. Aim 2. We hypothesize 1) that medication non-adherence will be significantly lower in Algorithm vs. Varenicline treatment group, 2) that these differences will be greatest among low-income subjects, and 3) that within the Patch Non-Responder Algorithm arms, abstinence rates will be higher among subjects opting for the High- vs. Low-Intensity Behavioral Intervention. Aim 3. We hypothesize 1) that a prospective economic analysis of Algorithm vs. Varenicline-based pharmacotherapy will show significant improvement in cost-benefit outcomes from the perspective of smokers, healthcare systems, insurance companies, and employers and 2) that of TSCP implementation and operations will show favorable cost- benefit outcomes for long-term operation.

Project-2 的总体目标是完成一项观察性研究（n = 3000），旨在测试 P50 在“转化戒烟计划”中开发的自适应药物治疗算法 （TSCP）。在 P50 资助的过去四年中，我们开发了一种药物治疗“算法”， 使用对尼古丁“测试贴片”的反应以及依赖性测试，将吸烟者分配给特定的 药物疗法。目标 1. 该研究将随机抽取 30 家杜克大学诊所参与 将戒烟计划 (TSCP) 转化为基于算法的药物疗法或伐尼克兰。后 招募1500名（50%）受试者，诊所的随机化状态将被逆转（交叉设计）， 允许控制临床效果和订单效果。我们假设 1) 吸烟者在 TSCP 中接受治疗 与 Varenicline 相比，基于算法的药物疗法将显示出显着更高的生化证实 戒烟后 12 周连续戒烟 30 天（主要研究结果），以及 2) 基于算法的 与伐尼克兰相比，药物治疗在 26 岁和 戒烟后 52 周。目标 2. 我们假设 1) 药物不依从性将显着降低 算法与伐尼克兰治疗组，2) 这些差异在低收入人群中最大 受试者，以及 3) 在补丁无响应算法组中，戒断率会更高 选择高强度与低强度行为干预的受试者。目标 3. 我们假设 1) 算法与基于 Varenicline 的药物疗法的前瞻性经济分析将显示显着 从吸烟者、医疗保健系统、保险的角度来看，成本效益结果得到改善 公司、雇主和 2) TSCP 实施和运营将显示出有利的成本- 长期运营的效益成果。