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      QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers

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          Abstract

          Background

          Tobacco use remains the leading cause of death and disability in the USA and is disproportionately concentrated among low socioeconomic status (SES) populations. Community Health Centers (CHCs) are a key venue for reaching low SES populations with evidence-based tobacco cessation treatment such as Quitlines. Electronic health record (EHR)-based interventions at the point-of-care, text messaging (TM), and phone counseling have the potential to increase Quitline reach and are feasible to implement within CHCs. However, there is a lack of data to inform how, when, and in what combination these strategies should be implemented. The aims of this cluster-randomized trial are to evaluate multi-level implementation strategies to increase the Reach (i.e., proportion of tobacco-using patients who enroll in the Quitline) and Impact (i.e., Reach × Efficacy [efficacy is defined as the proportion of tobacco-using patients who enroll in Quitline treatment that successfully quit]) and to evaluate characteristics of healthcare system, providers, and patients that may influence tobacco-use outcomes.

          Methods

          This study is a multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART), conducted in CHCs ( N = 33 clinics; N = 6000 patients). In the first phase, clinics will be randomized to two different EHR conditions. The second and third phases are patient-level randomizations based on prior treatment response. Patients who enroll in the Quitline receive no further interventions. In phase two, patients who are non-responders (i.e., patients who do not enroll in Quitline) will be randomized to receive either TM or continued-EHR. In phase three, patients in the TM condition who are non-responders will be randomized to receive either continued-TM or TM + phone coaching.

          Discussion

          This project will evaluate scalable, multi-level interventions to directly address strategic national priorities for reducing tobacco use and related disparities by increasing the Reach and Impact of evidence-based tobacco cessation interventions in low SES populations.

          Trial registration

          This trial was registered at ClinicalTrials.gov ( NCT03900767) on April 4th, 2019.

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          Author and article information

          Contributors
          Chelsey.schlechter@hci.utah.edu
          Journal
          Implement Sci
          Implement Sci
          Implementation Science : IS
          BioMed Central (London )
          1748-5908
          30 January 2020
          30 January 2020
          2020
          : 15
          : 9
          Affiliations
          [1 ]ISNI 0000 0000 9206 2401, GRID grid.267308.8, Center for Health Promotion and Prevention Research, Department of Health Promotion & Behavioral Sciences, , University of Texas Health Science Center at Houston School of Public Health, ; 7000 Fannin St, Houston, TX 77030 USA
          [2 ]ISNI 0000 0001 2193 0096, GRID grid.223827.e, Center for Health Outcomes and Population Equity, Huntsman Cancer Institute, , University of Utah, ; 2000 Circle of Hope Dr, Salt Lake City, UT 84112 USA
          [3 ]ISNI 0000 0001 2193 0096, GRID grid.223827.e, Department of Biomedical Informatics, , University of Utah, ; 421 Wakara Way #140, Salt Lake City, UT 84108 USA
          [4 ]ISNI 0000 0000 8761 1402, GRID grid.492404.f, Association for Utah Community Health, ; 860 E 4500 S, Murray, UT 84107 USA
          [5 ]ISNI 0000 0001 2193 0096, GRID grid.223827.e, Department of Population Health Sciences, , University of Utah, ; 295 Chipeta Way, Salt Lake City, UT 84108 USA
          [6 ]ISNI 0000000086837370, GRID grid.214458.e, Institute for Social Research, , University of Michigan, ; 426 Thompson St, Ann Arbor, MI 48104 USA
          [7 ]ISNI 0000 0004 0460 7459, GRID grid.280326.d, Utah Department of Health, ; 288 N 1460 W, Salt Lake City, UT 84116 USA
          Article
          967
          10.1186/s13012-020-0967-2
          6993416
          32000812
          a163283b-a66f-466d-aba1-bbc2697ec276
          © The Author(s). 2020

          Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

          History
          : 18 December 2019
          : 13 January 2020
          Funding
          Funded by: FundRef http://dx.doi.org/10.13039/100006093, Patient-Centered Outcomes Research Institute;
          Award ID: PCS-2017C2-7613
          Award Recipient :
          Funded by: FundRef http://dx.doi.org/10.13039/100006108, National Center for Advancing Translational Sciences;
          Award ID: UL1TR002538
          Funded by: National Cancer Institute
          Award ID: P30CA042014
          Funded by: FundRef http://dx.doi.org/10.13039/100010637, Huntsman Cancer Foundation;
          Award ID: NA
          Categories
          Study Protocol
          Custom metadata
          © The Author(s) 2020

          Medicine
          tobacco cessation,adaptive intervention,implementation science,health information technology,quitline,implementation strategy

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