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

Award Number: R01CA258669
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/19/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $618,640 )
2025	2025	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	4	8/22/2025	NON-COMPETING CONTINUATION	$618,640
														Subtotal = $618,640

Issue Date FY: 2024 ( Subtotal = $586,023 )
2024	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	001	3	7/30/2024	NON-COMPETING CONTINUATION	$586,023
2024	2023	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	2	2/6/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $586,023

Issue Date FY: 2023 ( Subtotal = $576,521 )
2023	2023	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	2	2/2/2023	NON-COMPETING CONTINUATION	$576,521
														Subtotal = $576,521

Issue Date FY: 2022 ( Subtotal = $649,204 )
2022	2022	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	1	1/19/2022	NEW	$649,204
														Subtotal = $649,204

Grand Total All Awards = $2,430,388

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

Award Number: R01CA258669

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/19/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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