Reach Through Equitable Implementation in Utah (REI-UT)

March 11, 2025 updated by: University of Utah

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute at The University of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reach of the Quit Services
Time Frame: up to 12 months after study enrollment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association between patient and clinic level predictor variables
Time Frame: 12 Months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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