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.

抽象的 吸烟在美国每年造成480,000例过早死亡，其中36％是由于 癌症。三分之二的吸烟者想戒烟，但不到三分之一的人使用证据戒烟 - 基于方法。因此，去年不到十分之一的吸烟者报告成功退出。 需要全面的传播策略来增加循证戒烟的利用 治疗和改善成年吸烟者的停止。绝大多数（> 70％）吸烟者访问了主要 护理医师（PCP）至少每年一次。因此，初级保健提供了一个成熟的机会 主动向成年吸烟者提供停止治疗。所有有资格获得中心的初级保健实践 需要补偿医疗保险和医疗补助服务以维护电子健康记录（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和 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提供的积极异步戒烟电子访问（E-Visit）。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，以确保所有吸烟者收到 基于证据的干预。最初的基线电子视野收集有关吸烟史的信息和 退出的动机，然后是算法，以确定最佳FDA批准的戒烟药物 规定。一个月的随访电子视野评估停止的进展。飞行员的临床结果 （n = 51）很有希望。在研究端（三个月），相对于往常的治疗（TAU），电子访问参与者， 使用戒烟药物的可能性高4.7倍，降低了4.1倍 每天卷烟> 50％，报告7天的禁欲的可能性高4.2倍。可行性 结果同样有希望 使用，将再次使用电子访问，并在电子访问期间照顾他们的提供者。我们现在建议 I型混合有效性实施试验，以全面评估相对于TAU的电子访问有效性 在跨初级保健设置交付时，同时评估实施。效力 结果将通过6个月的随访进行评估，包括：1）基于证据的戒烟处理 利用率，2）每天减少香烟，以及3）生化验证的7天的戒烟。 实施结果将在患者，提供者和组织级别进行评估。这个程序的 研究有可能获得广泛和直接的好处：1）吸烟者，他们将增加治疗的访问权限， 2）PCP，他们可以更有效地治疗吸烟者，同时还可以提供额外的报销服务，3） 护理系统，可以提高遵守戒烟治疗的联合委员会建议。