Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery via Primary Care

主动戒烟电子就诊的混合 1 型有效性实施试验，通过初级保健进行可扩展交付

• 批准号: 10365698
• 负责人: Jennifer Renee Dahne
• 金额: $ 64.92万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-19 至 2026-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10365698
• 关键词: Abstinence; Academic Medical Centers; Address; Adoption; Adult; Algorithms; Biochemical; Bupropion; Cancer Control; Caring; Cessation of life; Cigarette; Clinic; Clinical; Clinical Trials; Clinical effectiveness; Code; Counseling; Data; Data Collection; Dissemination and Implementation; Drug Prescriptions; Effectiveness; Effectiveness of Interventions; Electronic Health Record; Ensure; Environment; Evidence based intervention; Evidence based treatment; FDA approved; Familiarity; Goals; Guidelines; Health Services Accessibility; Healthcare Systems; Hybrids; Intervention; Interview; Joints; Malignant Neoplasms; Methods; Modeling; Motivation; Outcome; Participant; Patients; Penetration; Pharmaceutical Preparations; Physicians; Pilot Projects; Practice Guidelines; Prevalence; Primary Care Physician; Primary Health Care; Proctor framework; Provider; Randomized; Randomized Clinical Trials; Recommendation; Reporting; Research; Research Project Grants; Resources; Services; Site; Smoker; Smoking Cessation Intervention; Smoking History; Smoking Status; System; Testing; Time; Tobacco use; Trust; United States; United States Centers for Medicare and Medicaid Services; United States Public Health Service; Visit; Withholding Treatment; arm; cancer prevention; care systems; cigarette smoking; digital; dissemination strategy; eVisit; effectiveness implementation trial; effectiveness outcome; effectiveness trial; evidence base; follow-up; implementation barriers; implementation cost; implementation evaluation; implementation facilitators; implementation outcomes; improved; informant; nicotine replacement; premature; primary care setting; programs; psychosocial; quitline; relative effectiveness; self help; smoking cessation; tool; treatment as usual; varenicline

ABSTRACT Cigarette smoking causes 480,000 premature deaths each year in the United States, of which 36% are due to cancer. Two-thirds of smokers want to quit, but fewer than one-third make a quit attempt using an evidence- based approach. Consequently, fewer than one in ten smokers report quitting successfully in the last year. Comprehensive dissemination strategies are needed to increase utilization of evidence-based cessation treatments and improve cessation among adult smokers. The vast majority (>70%) of smokers visit a primary care physician (PCP) at least once per year. As such, primary care offers a ripe opportunity through which to proactively deliver cessation treatment to adult smokers. All primary care practices that qualify for Centers for Medicare and Medicaid Services reimbursement are required to maintain electronic health records (EHRs) with coded smoking status data for adult patients. These data can be utilized to proactively identify smokers and deliver treatment. Our team recently completed a pilot study to develop, refine, and preliminarily evaluate a proactive asynchronous smoking cessation electronic visit (e-visit) delivered via the EHR. The goal of the e-visit is to automate best practice guidelines for cessation treatment via primary care to ensure that all smokers receive an evidence-based intervention. An initial baseline e-visit gathers information about smoking history and motivation to quit, followed by an algorithm to determine the best FDA-approved cessation medication to prescribe. A one-month follow-up e-visit assesses progress toward cessation. Clinical outcomes of our pilot (N=51) were promising. At study end (three months), e-visit participants, relative to treatment as usual (TAU), were 4.7 times more likely to have used a cessation medication, 4.1 times more likely to have reduced their cigarettes per day by >50%, and 4.2 times more likely to report 7-day point prevalence abstinence. Feasibility outcomes were similarly promising, with >85% of e-visit participants reporting that they found the e-visit easy to use, would use an e-visit again, and trusted their provider with their care during the e-visit. We now propose a Hybrid Type I effectiveness-implementation trial to comprehensively assess e-visit effectiveness relative to TAU while simultaneously evaluating implementation when delivered across primary care settings. Effectiveness outcomes will be assessed through 6-months of follow-up and include: 1) evidence-based cessation treatment utilization, 2) reduction in cigarettes per day, and 3) biochemically verified 7-day point prevalence abstinence. Implementation outcomes will be assessed at patient, provider, and organizational levels. This program of research has the potential for broad and direct benefits to: 1) smokers, who will have increased treatment access, 2) PCPs, who can more efficiently treat smokers while also having an additional reimbursable service, and 3) care systems, who can improve compliance with Joint Commission recommendations for cessation treatment.

摘要 在美国，吸烟每年导致48万人过早死亡，其中36%是由于吸烟。 癌三分之二的吸烟者想戒烟，但只有不到三分之一的人尝试戒烟， 基于方法。因此，不到十分之一的吸烟者报告在过去一年中成功戒烟。 需要全面的传播战略来增加循证戒烟的利用率 治疗和改善成年吸烟者的戒烟。绝大多数（>70%）吸烟者在初次就诊时 护理医生（PCP）每年至少一次。因此，初级保健提供了一个成熟的机会， 主动为成年吸烟者提供戒烟治疗。所有符合中心条件的初级保健实践， 医疗保险和医疗补助服务报销需要维护电子健康记录（EHR）， 成人患者的编码吸烟状态数据。这些数据可用于主动识别吸烟者， 提供治疗。我们的团队最近完成了一项试点研究，以开发，完善和初步评估 通过EHR提供的主动异步戒烟电子访视（e访视）。电子访问的目标 是通过初级保健自动化戒烟治疗的最佳实践指南，以确保所有吸烟者都能获得 循证干预初始基线电子访视收集有关吸烟史的信息， 戒烟的动机，然后是一个算法，以确定最好的FDA批准的戒烟药物， 开处方。一个月的随访电子访视评估戒烟进展。我们试点的临床结果 （N=51）有希望。在研究结束时（3个月），电子访视受试者，相对于常规治疗（TAU）， 使用戒烟药物的可能性高4.7倍，减少吸烟的可能性高4.1倍。 每天吸烟量增加> 50%，报告7天点戒烟率的可能性增加4.2倍。可行性 结果同样令人鼓舞，超过85%的电子访问参与者报告说，他们发现电子访问很容易 使用，将再次使用电子访问，并信任他们的提供者在电子访问期间的照顾。我们现在提出一个 混合I型有效性-实施试验，以全面评估电子访视相对于TAU的有效性 同时评估在初级保健环境中实施的情况。有效性 将通过6个月的随访评估结果，包括：1）循证戒烟治疗 利用率，2）每天吸烟量减少，以及3）经生化验证的7天时点戒烟率。 实施结果将在患者、提供者和组织层面进行评估。该方案 研究有可能给以下人群带来广泛和直接的好处：1）吸烟者，他们将获得更多的治疗， 2)PCP，他们可以更有效地治疗吸烟者，同时还提供额外的可报销服务，以及3） 护理系统，谁可以改善遵守联合委员会的建议，停止治疗。