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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial

Authors: Amanda L. Graham, Michael V. Burke, Megan A. Jacobs, Sarah Cha, Ivana T. Croghan, Darrell R. Schroeder, James P. Moriarty, Bijan J. Borah, Donna F. Rasmussen, M. Jody Brookover, Dale B. Suesse, David E. Midthun, J. Taylor Hays

Published in: Trials | Issue 1/2017

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Abstract

Background

Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment.

Methods

This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask–Advise–Refer; (2) a digital (WEB + TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB + TXT + TTS).

Discussion

The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital alone, but that it may not be as cost-effective or feasible for LCS programs to implement. This study is innovative in its use of interoperable, digital technologies to deliver a sustainable, scalable, high-impact cessation intervention and to facilitate its integration within clinical practice. It will add to the growing knowledge base about the overall effectiveness of digital interventions and their role in the healthcare delivery system.

Trial registration

ClinicalTrials.gov, NCT03084835. Registered on 9 March 2017.
Appendix
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Metadata
Title
An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial
Authors
Amanda L. Graham
Michael V. Burke
Megan A. Jacobs
Sarah Cha
Ivana T. Croghan
Darrell R. Schroeder
James P. Moriarty
Bijan J. Borah
Donna F. Rasmussen
M. Jody Brookover
Dale B. Suesse
David E. Midthun
J. Taylor Hays
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2312-x

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