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

Maria E Fernandez, Chelsey R Schlechter, Guilherme Del Fiol, Bryan Gibson, Kensaku Kawamoto, Tracey Siaperas, Alan Pruhs, Tom Greene, Inbal Nahum-Shani, Sandra Schulthies, Marci Nelson, Claudia Bohner, Heidi Kramer, Damian Borbolla, Sharon Austin, Charlene Weir, Timothy W Walker, Cho Y Lam, David W Wetter, Maria E Fernandez, Chelsey R Schlechter, Guilherme Del Fiol, Bryan Gibson, Kensaku Kawamoto, Tracey Siaperas, Alan Pruhs, Tom Greene, Inbal Nahum-Shani, Sandra Schulthies, Marci Nelson, Claudia Bohner, Heidi Kramer, Damian Borbolla, Sharon Austin, Charlene Weir, Timothy W Walker, Cho Y Lam, David W Wetter

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.

Keywords: Adaptive intervention; Health information technology; Implementation science; Implementation strategy; Quitline; Tobacco cessation.

Conflict of interest statement

KK reports honoraria, consulting, sponsored research, or sponsored travel related to health information technology (IT) in the past 3 years with McKesson InterQual, Hitachi, Pfizer, Premier, Klesis Healthcare, RTI International, Vanderbilt University, the University of Washington, the University of California at San Francisco, the Mayo Clinic, the Association of American Medical Colleges, and the U.S. Office of the National Coordinator for Health IT (via ESAC, JBS International, A+ Government Solutions, Hausam Consulting, and Security Risk Solutions). KK is also an unpaid board member of the non-profit Health Level Seven International health IT standard development organization, and he has helped develop a number of health IT tools which may be commercialized to enable wider impact. None of these relationships have direct relevance to the manuscript but are reported in the interest of full disclosure.

Figures

Fig. 1
Fig. 1
Conceptual framework
Fig. 2
Fig. 2
Study design
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Fig. 3
Clinic and patient flow diagram

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