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

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.

Workflow analysis for design of an electronic health record-based tobacco cessation intervention in community health centers

“…The upcoming trial will investigate whether these differences in implementation affect the effectiveness of AAC. 38 …”

“…A detailed description of the study protocol has been published elsewhere. 25 In the first randomization of the trial, clinics will be randomized to receive one of two versions of AAC. The procedures outlined in this report are one component of a systematic process to optimize the sequencing and adaption of the implementation strategies for QuitSMART Utah.…”

Application of community – engaged dissemination and implementation science to improve health equity

“…The study consists of three clinic and patient level implementation strategies to increase the reach ( Glasgow et al, 2019 ) of Quitlines: 1) Ask – Advise – Connect (AAC), ( Vidrine et al, 2013 , Vidrine et al, 2013 , Piñeiro et al, 2020 ) a clinic level implementation strategy at the point of care that uses the electronic health record (EHR) to prompt the clinic practice team to systematically ask all patients about tobacco use, advise tobacco using patients to quit, and connect interested patients directly and electronically to the Utah Tobacco Quit Line (hereafter referred to as Quit Line); 2) Text messaging, a patient facing implementation strategy to provide additional opportunities to enroll in the Quit Line; and 3) Motivation And Problem Solving (MAPS) coaching calls, a patient facing implementation strategy to address patients’ motivation and barriers to engaging with the Quit Line and quitting tobacco. Additional information on QuitSMART Utah has been provided elsewhere ( Fernandez et al, 2020 , Gibson et al, 2021 ). The procedures for QuitSMART Utah are approved by the University Institutional Review Board (#00111985).…”

“…Explicit description of the community-engagement process (e.g., when and how to engage community stakeholder partners; the various roles community stakeholders play in implementation research) is important to understand what processes and partnerships contribute to implementation success, and provide information on the generalizability of implementation research to other settings. Therefore, the purpose of this paper is to describe the community-engagement process used to develop and implement a multilevel, pragmatic randomized trial to increase the reach and impact of evidence-based tobacco cessation treatment among Community Health Center (CHC) patients across the state of Utah (QuitSMART Utah) ( Fernandez et al, 2020 ).…”

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“…Fortunately, some emerging studies deal with at least several components of our proposed model. For instance, the Quit Sequential Multiple Assignment Randomization Trial Utah trial uses a cluster-randomized, multilevel sequential multiple assignment randomized model to examine strategies to increase reach and efficacy in community health centers [ 37 ].…”