Tobacco Cessation Interventions for Smoking Addiction

(REI-UT Trial)

Overseen By Chelsey Schlechter, MPH, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Opt-out of study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1560 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Chelsey Schlechter, MPH, PhD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

This trial is for patients who use tobacco and live in areas of persistent poverty. They must be part of a safety-net healthcare system and attend Community Health Centers. The study aims to help them quit smoking by increasing access to proven treatments.

Inclusion Criteria

Valid cell phone number in the electronic health record (EHR)

Live in a persistent poverty census tract

Electronic health records indicate they have not opted out of receiving text contact from the clinic

Exclusion Criteria

Opt-out of study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinic Level Implementation

Implementation of Ask-Advise-Connect (AAC) strategy to address tobacco cessation and SDOH needs

4 weeks

1 visit (in-person)

Patient Level Intervention

Randomized patient-level strategies including Conversational Agents and Patient Navigation

12 months

Proactive outreach via text and calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Patient Navigation and Conversational Agents

Trial Overview The trial tests patient-level strategies like Conversational Agents & Patient Navigation, and clinic-level strategies such as Ask-Advise-Connect, aiming to improve the reach of tobacco cessation services among those living in poverty.

Participant Groups

Group I: 9: Non-Bundled, PPN Dose, CA6 Experimental Treatment 3 Interventions

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

Group II: 8: Non-Bundled, PPN Dose, CA3 Experimental Treatment 3 Interventions

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

Group III: 7: Non-Bundled, PPN Dose, CA1 Experimental Treatment 3 Interventions

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

Group IV: 6: Non-Bundled, RPN, CA12 Experimental Treatment 3 Interventions

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

Group V: 5: Non-Bundled, RPN, CA9 Experimental Treatment 3 Interventions

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

Group VI: 4: Non-Bundled, RPN, CA6 Experimental Treatment 3 Interventions

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

Group VII: 3: Non-Bundled, RPN, CA3 Experimental Treatment 3 Interventions

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

Group VIII: 2: Non-Bundled, RPN, CA1 Experimental Treatment 3 Interventions

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

Group IX: 21: Bundled, PPN, CA12 Experimental Treatment 3 Interventions

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

Group X: 20: Bundled, PPN, CA9 Experimental Treatment 3 Interventions

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

Group XI: 1: Clinic Level Intervention Only Experimental Treatment 1 Intervention

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

Group XII: 19: Bundled, PPN, CA6 Experimental Treatment 3 Interventions

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

Group XIII: 18: Bundled, PPN, CA3 Experimental Treatment 3 Interventions

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

Group XIV: 17: Bundled, PPN, CA1 Experimental Treatment 3 Interventions

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

Group XV: 16: Bundled, RPN, CA12 Experimental Treatment 3 Interventions

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

Group XVI: 15: Bundled, RPN, CA9 Experimental Treatment 3 Interventions

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

Group XVII: 14: Bundled, RPN, CA6 Experimental Treatment 3 Interventions

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

Group XVIII: 13: Bundled, RPN, CA3 Experimental Treatment 3 Interventions

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

Group XIX: 12: Bundled, RPN, CA1 Experimental Treatment 3 Interventions

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

Group XX: 11: Non-Bundled, PPN Dose, CA12 Experimental Treatment 3 Interventions

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

Group XXI: 10: Non-Bundled, PPN Dose, CA9 Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+