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Tobacco Use CessationAddictionDigital healthMental healthBehavioralBehavioral

What this study is

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.

What's being tested

  • Clinic Level: AAC - SDOH, AAC - Tobacco

    Intervention · BEHAVIORAL

    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).

  • Non-Bundled

    Intervention · BEHAVIORAL

    All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.

  • Bundled

    Intervention · BEHAVIORAL

    All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.

  • Dose 1

    Intervention · BEHAVIORAL

    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.

  • Dose 3

    Intervention · BEHAVIORAL

    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.

  • Dose 6

    Intervention · BEHAVIORAL

    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.

  • Dose 9

    Intervention · BEHAVIORAL

    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.

  • Dose 12

    Intervention · BEHAVIORAL

    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.

  • RPN

    Intervention · BEHAVIORAL

    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.

  • PPN

    Intervention · BEHAVIORAL

    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.

Study details

Official title
Reach Through Equitable Implementation in Utah (REI-UT)
Sponsor
University of Utah
Conditions
Tobacco Use Cessation · Tobacco Use · Tobacco Smoking · Tobacco Chewing · Tobacco Dependence
Enrolling
1,560 people
Starts
2025-02-13
Est. completion
2028-01-30
Design
Open-label, randomized, factorial
Record
View on ClinicalTrials.gov ↗