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

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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.