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Reach Through Equitable Implementation in Utah

ConditionsTobacco Use CessationTobacco UseTobacco SmokingTobacco ChewingTobacco Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age

Speak English or Spanish

Currently use tobacco

Live in a persistent poverty census tract

Disqualifiers

Opt-out of study

Trial design

Design model

Factorial

Treatments tested in this trial

  • Clinic Level: AAC - SDOH, AAC - Tobacco

    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

    Behavioral

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

  • Bundled

    Behavioral

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

  • Dose 1

    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

    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

    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

    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

    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

    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

    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.

Treatment groups

1,560 Participants
are divided into 21 treatment groups

21

Treatment groups

See each treatment group below.

Group A: 1: Clinic Level Intervention OnlyOther 1 intervention
Group B: 2: Non-Bundled, RPN, CA1Experimental treatment 3 interventions
Group C: 3: Non-Bundled, RPN, CA3Experimental treatment 3 interventions
Group D: 4: Non-Bundled, RPN, CA6Experimental treatment 3 interventions
Group E: 5: Non-Bundled, RPN, CA9Experimental treatment 3 interventions
Group F: 6: Non-Bundled, RPN, CA12Experimental treatment 3 interventions
Group G: 7: Non-Bundled, PPN Dose, CA1Experimental treatment 3 interventions
Group H: 8: Non-Bundled, PPN Dose, CA3Experimental treatment 3 interventions
Group I: 9: Non-Bundled, PPN Dose, CA6Experimental treatment 3 interventions
Group J: 10: Non-Bundled, PPN Dose, CA9Experimental treatment 3 interventions
Group K: 11: Non-Bundled, PPN Dose, CA12Experimental treatment 3 interventions
Group L: 12: Bundled, RPN, CA1Experimental treatment 3 interventions
Group M: 13: Bundled, RPN, CA3Experimental treatment 3 interventions
Group N: 14: Bundled, RPN, CA6Experimental treatment 3 interventions
Group O: 15: Bundled, RPN, CA9Experimental treatment 3 interventions
Group P: 16: Bundled, RPN, CA12Experimental treatment 3 interventions
Group Q: 17: Bundled, PPN, CA1Experimental treatment 3 interventions
Group R: 18: Bundled, PPN, CA3Experimental treatment 3 interventions
Group S: 19: Bundled, PPN, CA6Experimental treatment 3 interventions
Group T: 20: Bundled, PPN, CA9Experimental treatment 3 interventions
Group U: 21: Bundled, PPN, CA12Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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.
3

Patient Abstinence

Proportion of patients who report 7 or 30 day abstinence among those sampled.

Time frame
Up to 12 months after study enrollment
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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