An interventional study of Clinic Level: AAC - SDOH, AAC - Tobacco and Non-Bundled in Tobacco Use Cessation, Tobacco Use and Tobacco Smoking, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by University of Utah · Not applicable, Interventional, and Prevention
The goal of this pragmatic, multilevel Type III Hybrid Effectiveness-Implementation trial is to increase the reach of existing evidence-based interventions (EBIs) for tobacco cessation and to mitigate the impact of adverse Social Drivers of Health (SDOH) among safety-net healthcare system patients who live in persistent poverty (PP) census tracts.
Aim 1: Test the ability of patient-level Conversational Agents (CA) \& Patient Navigation (PN) dissemination strategies to increase the Reach (primary outcome) of evidence-based tobacco cessation treatment delivered via the Utah Tobacco and Nicotine Quit Services (Quit Services) among Community Health Center (CHC) patients who use tobacco and live in persistent poverty census tracts. Secondary analyses will examine the outcome of Reach of services for SDOH among these patients and will evaluate both 1) patient-level CA and PN dissemination strategies and 2) a clinic-level implementation strategy using a pre-post design.
Aim 2: Explore contextual factors (e.g., clinic size, patient composition, rurality, patient demographics) related to the Reach, Adoption, Implementation, and potential Maintenance of strategies.
Aim 3: Determine the cost-effectiveness of clinic and patient-level strategies based on Quit Services enrollment and service receipt for SDOH.
This trial implements a clinic-level implementation strategy, Ask-Advise-Connect (AAC), to address tobacco cessation and needs around social drivers of health for patients in all participating clinics. Eligible patients who are not enrolled in Quit Services four weeks after the clinical encounter, will receive text messages from a chatbot offering information and connections to the Quit Services and patient navigation support from a Community Health Worker.
REI-UT is a pragmatic, multilevel Type III Hybrid Effectiveness-Implementation trial with a 2x2x5 factorial experimental design. It consists of clinic level implementation strategies (AAC - SDOH, AAC - Tobacco), which will be implemented in all participating clinics and four patient level interventions, which will be randomized based on Quit Services response. Individuals who do not enroll in the Quit Services after four weeks of receiving the clinic level strategy will be randomly assigned to one of 20 conditions in the 2X2X5 factorial design.
Clinic Level Implementation Strategy:
Ask-Advise-Connect (AAC) is a health information technology (HIT) implementation strategy that consists of Electronic Health Record (EHR) based point of care supports for the assessment of and referral to resources for tobacco use and SDOH (ASK).
Patient Level Implementation Strategies:
Patients eligible for the patient level strategies must have had a recent visit at a participating clinic; are at least 18 years of age; currently use tobacco; live in a PP census tract; speak English or Spanish; have a valid cell phone number in the their clinics' EHR that can send and receive text messages; and have not opted out of the study. The patient level randomization is based on Quit Services response. Descriptions of the patient level conditions are as follows:
Eligible individuals who do not enroll in the Quit Services after four weeks will be randomly assigned to one of 20 conditions in the 2X2X5 factorial design (Non-Bundled \& RPN \& Dose, Non-Bundled \& PPN \& Dose, Bundled \& RPN \& Dose, Bundled \& PPN \& Dose, for each dose of 1, 3, 6, 9, 12).
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's planned enrollment of 1,560 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
Patients who enrolled in Quit Services within 4 weeks after the clinical encounter will not be randomized to patient level conditions. Clinic Level: AAC - Tobacco, AAC - SDOH Bundled/Non-Bundled: NA PRN/RPN: NA Dose: NA
Behavioral: Clinic Level: AAC - SDOH, AAC - Tobacco
Patients who do not enroll Quit Services within 4 weeks after their clinical encounter will be randomized to receive patient-level strategies. Patients will receive a single proactive outreach from the CA (CA1) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA1
Behavioral: Non-Bundled · Behavioral: Dose 1 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA3
Behavioral: Non-Bundled · Behavioral: Dose 3 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA6
Behavioral: Non-Bundled · Behavioral: Dose 6 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA9
Behavioral: Non-Bundled · Behavioral: Dose 9 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive twelve proactive outreach opportunities from the CA (CA12) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA12
Behavioral: Non-Bundled · Behavioral: Dose 12 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive one proactive outreach opportunity from the CA (CA1) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA1
Behavioral: Non-Bundled · Behavioral: Dose 1 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA3
Behavioral: Non-Bundled · Behavioral: Dose 3 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA6
Behavioral: Non-Bundled · Behavioral: Dose 6 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA9
Behavioral: Non-Bundled · Behavioral: Dose 9 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive twelve proactive outreach opportunities from the CA (CA12) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA12
Behavioral: Non-Bundled · Behavioral: Dose 12 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive one proactive outreach opportunity from the CA (CA1) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA1
Behavioral: Bundled · Behavioral: Dose 1 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA3
Behavioral: Bundled · Behavioral: Dose 3 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA6
Behavioral: Bundled · Behavioral: Dose 6 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA9
Behavioral: Bundled · Behavioral: Dose 9 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive 12 proactive outreach opportunities from the CA (CA12) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA12
Behavioral: Bundled · Behavioral: Dose 12 · Behavioral: RPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive one proactive outreach opportunity from the CA (CA1) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA1
Behavioral: Bundled · Behavioral: Dose 1 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA3
Behavioral: Bundled · Behavioral: Dose 3 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA6
Behavioral: Bundled · Behavioral: Dose 6 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA9
Behavioral: Bundled · Behavioral: Dose 9 · Behavioral: PPN
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive twelve proactive outreach opportunities from the CA (CA12) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA12
Behavioral: Bundled · Behavioral: Dose 12 · Behavioral: PPN
Ask-Advise-Connect (AAC) is a health information technology (HIT) implementation strategy that consists of EHR-based point-of-care supports for the assessment of tobacco use and Social Drivers of Health (SDOH).
All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.
All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
The number of proactive outreach opportunities for CA the patient receives. Patient will receive 1 opportunity for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.
The number of proactive outreach opportunities for CA the patient receives. Patient will receive 3 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.
The number of proactive outreach opportunities for CA the patient receives. Patient will receive 6 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.
The number of proactive outreach opportunities for CA the patient receives. Patient will receive 9 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.
The number of proactive outreach opportunities for CA the patient receives. Patient will receive 12 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.
Reactive Patient Navigation Only (RPN): Patient can request to speak to a CHW, over 12 months following a patient's initial clinic visit, at any time.
Proactive Patient Navigation (PPN): Patient is proactively called, over 12 months following a patient's initial clinic visit, by a CHW up to 4 times.
Reach of the Quit Services
Reach of the Quit Services is the number of eligible patients who officially enroll in the Quit Services over the total number of eligible patients.
Time frame: up to 12 months after study enrollment
Association between patient and clinic level predictor variables
We will perform separate analyses using generalized linear mixed models to investigate the association between patient and clinic level predictor variables (such as Reach, Effectiveness, Adoption, Implementation, and Maintenance.) derived from our conceptual model with process outcomes for AAC, CA, and PN dissemination and implementation strategies. This outcome measure will report if there is an associate between patient and clinical level predictor variable.
Time frame: 12 Months
Reach -- SDOH
Proportion of patients who use tobacco, are seen at a participating clinic, live in PP census tract, and receive services for SDOH (among sampled patients only)
Time frame: Up to 12 months after enrollment in study.
Patient Abstinence
Proportion of patients who report 7 or 30 day abstinence among those sampled.
Time frame: Up to 12 months after study enrollment
Reach - Offer
Proportion of patients offered connection to Quit Services/total patients offered connection to Quit Services.
Time frame: Up to 12 months after study enrollment
Reach -- Connect
Proportion of patients who accept connection to Quit Services out of eligible patients
Time frame: Up to 12 months after study enrollment
Patient Engagement
Proportion of patients who interact with CA or PN out of eligible patients.
Time frame: Up to 12 months after study enrollment
Cost-Effectiveness
Cost-effectiveness of strategies
Time frame: Up to 12 months after study enrollment
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