Reach Through Equitable Implementation in Utah (REI-UT)

Reach Through Equitable Implementation in Utah (REI-UT)

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use; Tobacco Smoking; Tobacco Use Cessation; Tobacco Dependence; Tobacco Chewing
• Intervention / Treatment: Behavioral: Clinic Level: AAC - SDOH, AAC - Tobacco; Behavioral: Non-Bundled; Behavioral: Dose 1; Behavioral: RPN; Behavioral: Dose 3; Behavioral: Dose 6; Behavioral: Dose 9; Behavioral: Dose 12; Behavioral: PPN; Behavioral: Bundled

Detailed Description

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:

• Bundled: All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
• Non-Bundled: All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.
• Reactive Patient Navigation Only (RPN): Patient can request to speak to a Community Health Worker (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.
• Dose: The number of proactive outreach opportunities for Conversational Agent (CA) the patient receives. Patient will receive 1, 3, 6, 9, or 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.

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).

• Study Type: Interventional
• Enrollment (Estimated): 1560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chelsey Schlechter, PhD; Phone Number: 801-213-5704; Email: chelsey.schlechter@hci.utah.edu
• Study Contact Backup: Name: Chelsey Schlechter, MPH, PhD; Phone Number: 801-213-5704; Email: chelsey.schlechter@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute at the University of Utah
      • Contact: Chelsey Schlechter, PhD; Phone Number: 801-213-5704; Email: chelsey.schlechter@hci.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 years of age
• Speak English or Spanish
• Currently use tobacco
• Live in a persistent poverty census tract
• Present at participating clinics
• Valid cell phone number in the electronic health record (EHR)
• Electronic health records indicate they have not opted out of receiving text contact from the clinic

Exclusion Criteria:

• Opt-out of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

21

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1: Clinic Level Intervention Only; 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; 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).
Experimental: 2: Non-Bundled, RPN, CA1; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: Dose 1; 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.; Behavioral: RPN; 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.
Experimental: 3: Non-Bundled, RPN, CA3; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: RPN; 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.; Behavioral: Dose 3; 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.
Experimental: 4: Non-Bundled, RPN, CA6; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: RPN; 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.; Behavioral: Dose 6; 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.
Experimental: 5: Non-Bundled, RPN, CA9; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: RPN; 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.; Behavioral: Dose 9; 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.
Experimental: 6: Non-Bundled, RPN, CA12; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: RPN; 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.; Behavioral: Dose 12; 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.
Experimental: 7: Non-Bundled, PPN Dose, CA1; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: Dose 1; 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.; Behavioral: PPN; 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.
Experimental: 8: Non-Bundled, PPN Dose, CA3; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: Dose 3; 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.; Behavioral: PPN; 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.
Experimental: 9: Non-Bundled, PPN Dose, CA6; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: Dose 6; 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.; Behavioral: PPN; 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.
Experimental: 10: Non-Bundled, PPN Dose, CA9; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: Dose 9; 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.; Behavioral: PPN; 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.
Experimental: 11: Non-Bundled, PPN Dose, CA12; 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; All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.; Behavioral: Dose 12; 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.; Behavioral: PPN; 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.
Experimental: 12: Bundled, RPN, CA1; 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: Dose 1; 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.; Behavioral: RPN; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 13: Bundled, RPN, CA3; 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: RPN; 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.; Behavioral: Dose 3; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 14: Bundled, RPN, CA6; 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: RPN; 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.; Behavioral: Dose 6; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 15: Bundled, RPN, CA9; 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: RPN; 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.; Behavioral: Dose 9; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 16: Bundled, RPN, CA12; 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: RPN; 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.; Behavioral: Dose 12; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 17: Bundled, PPN, CA1; 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: Dose 1; 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.; Behavioral: PPN; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 18: Bundled, PPN, CA3; 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: Dose 3; 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.; Behavioral: PPN; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 19: Bundled, PPN, CA6; 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: Dose 6; 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.; Behavioral: PPN; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 20: Bundled, PPN, CA9; 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: Dose 9; 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.; Behavioral: PPN; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Experimental: 21: Bundled, PPN, CA12; 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: Dose 12; 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.; Behavioral: PPN; 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.; Behavioral: Bundled; All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 12 months after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Up to 12 months after enrollment in study.
Patient Abstinence	Proportion of patients who report 7 or 30 day abstinence among those sampled.	Up to 12 months after study enrollment
Reach - Offer	Proportion of patients offered connection to Quit Services/total patients offered connection to Quit Services.	Up to 12 months after study enrollment
Reach -- Connect	Proportion of patients who accept connection to Quit Services out of eligible patients	Up to 12 months after study enrollment
Patient Engagement	Proportion of patients who interact with CA or PN out of eligible patients.	Up to 12 months after study enrollment
Cost-Effectiveness	Cost-effectiveness of strategies	Up to 12 months after study enrollment

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder
• Other Study ID Numbers: HCI165288; 5U54CA280812-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No