Tobacco Use CessationREI-UTNCT06881069
Reach Through Equitable Implementation in Utah
A study testing Clinic Level: AAC - SDOH, AAC - Tobacco, Non-Bundled and Bundled in people with Tobacco Use Cessation and Tobacco Use, run by University of Utah at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Tobacco Use, Tobacco Smoking
- What is being tested?
- Clinic Level: AAC - SDOH, AAC - Tobacco, Non-Bundled and Bundled
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- Opt-out of study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Chelsey Schlechter, PhD, 801-213-5704, chelsey.schlechter@hci.utah.edu
About this study
Official title: 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.
Read more
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.
Read the 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).
- Being tested
- Clinic Level: AAC - SDOH, AAC - Tobacco, Non-Bundled, Bundled, Dose 1, Dose 3
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use, Tobacco Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic Level: AAC - SDOH, AAC - TobaccoBehavioural
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-BundledBehavioural
All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.
BundledBehavioural
All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
Dose 1Behavioural
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 3Behavioural
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 6Behavioural
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 9Behavioural
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 12Behavioural
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.
RPNBehavioural
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.
PPNBehavioural
Proactive Patient Navigation (PPN): Patient is proactively called, over 12 months following a patient's initial clinic visit, by a CHW up to 4 times.
| Study group | Role | What they receive |
|---|---|---|
| 1: Clinic Level Intervention Only | Other | 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 Receives: Behavioral: Clinic Level: AAC - SDOH, AAC - Tobacco |
| 2: Non-Bundled, RPN, CA1 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 1; Behavioral: RPN |
| 3: Non-Bundled, RPN, CA3 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 3; Behavioral: RPN |
| 4: Non-Bundled, RPN, CA6 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 6; Behavioral: RPN |
| 5: Non-Bundled, RPN, CA9 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 9; Behavioral: RPN |
| 6: Non-Bundled, RPN, CA12 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 12; Behavioral: RPN |
| 7: Non-Bundled, PPN Dose, CA1 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 1; Behavioral: PPN |
| 8: Non-Bundled, PPN Dose, CA3 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 3; Behavioral: PPN |
| 9: Non-Bundled, PPN Dose, CA6 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 6; Behavioral: PPN |
| 10: Non-Bundled, PPN Dose, CA9 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 9; Behavioral: PPN |
| 11: Non-Bundled, PPN Dose, CA12 | Experimental | 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 Receives: Behavioral: Non-Bundled; Behavioral: Dose 12; Behavioral: PPN |
| 12: Bundled, RPN, CA1 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 1; Behavioral: RPN |
| 13: Bundled, RPN, CA3 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 3; Behavioral: RPN |
| 14: Bundled, RPN, CA6 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 6; Behavioral: RPN |
| 15: Bundled, RPN, CA9 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 9; Behavioral: RPN |
| 16: Bundled, RPN, CA12 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 12; Behavioral: RPN |
| 17: Bundled, PPN, CA1 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 1; Behavioral: PPN |
| 18: Bundled, PPN, CA3 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 3; Behavioral: PPN |
| 19: Bundled, PPN, CA6 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 6; Behavioral: PPN |
| 20: Bundled, PPN, CA9 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 9; Behavioral: PPN |
| 21: Bundled, PPN, CA12 | Experimental | 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 Receives: Behavioral: Bundled; Behavioral: Dose 12; Behavioral: PPN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months after study enrollment
Secondary outcomes (7)
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.
Measured: 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)
Measured: Up to 12 months after enrollment in study.
Patient Abstinence
Proportion of patients who report 7 or 30 day abstinence among those sampled.
Measured: Up to 12 months after study enrollment
Reach - Offer
Proportion of patients offered connection to Quit Services/total patients offered connection to Quit Services.
Measured: Up to 12 months after study enrollment
Reach -- Connect
Proportion of patients who accept connection to Quit Services out of eligible patients
Measured: Up to 12 months after study enrollment
Patient Engagement
Proportion of patients who interact with CA or PN out of eligible patients.
Measured: Up to 12 months after study enrollment
Cost-Effectiveness
Cost-effectiveness of strategies
Measured: Up to 12 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start13 Feb 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chelsey Schlechter, MPH, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881069
- Sponsor's protocol ID
- HCI165288
- Other IDs
- 5U54CA280812-02
- Acronym
- REI-UT
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reach Through Equitable Implementation in Utah (REI-UT)
- ClinicalTrials.gov ID
- NCT06881069
- Acronym / sponsor ID
- REI-UT / HCI165288
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 21
| Arm | Type | Receives |
|---|---|---|
| 1: Clinic Level Intervention Only | Other | Behavioral: Clinic Level: AAC - SDOH, AAC - TobaccoPatients 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 |
| 2: Non-Bundled, RPN, CA1 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 1, Behavioral: RPNPatients 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 |
| 3: Non-Bundled, RPN, CA3 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 3, Behavioral: RPNPatients 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 |
| 4: Non-Bundled, RPN, CA6 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 6, Behavioral: RPNPatients 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 |
| 5: Non-Bundled, RPN, CA9 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 9, Behavioral: RPNPatients 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 |
| 6: Non-Bundled, RPN, CA12 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 12, Behavioral: RPNPatients 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 |
| 7: Non-Bundled, PPN Dose, CA1 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 1, Behavioral: PPNPatients 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 |
| 8: Non-Bundled, PPN Dose, CA3 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 3, Behavioral: PPNPatients 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 |
| 9: Non-Bundled, PPN Dose, CA6 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 6, Behavioral: PPNPatients 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 |
| 10: Non-Bundled, PPN Dose, CA9 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 9, Behavioral: PPNPatients 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 |
| 11: Non-Bundled, PPN Dose, CA12 | Experimental | Behavioral: Non-Bundled, Behavioral: Dose 12, Behavioral: PPNPatients 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 |
| 12: Bundled, RPN, CA1 | Experimental | Behavioral: Bundled, Behavioral: Dose 1, Behavioral: RPNPatients 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 |
| 13: Bundled, RPN, CA3 | Experimental | Behavioral: Bundled, Behavioral: Dose 3, Behavioral: RPNPatients 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 |
| 14: Bundled, RPN, CA6 | Experimental | Behavioral: Bundled, Behavioral: Dose 6, Behavioral: RPNPatients 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 |
| 15: Bundled, RPN, CA9 | Experimental | Behavioral: Bundled, Behavioral: Dose 9, Behavioral: RPNPatients 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 |
| 16: Bundled, RPN, CA12 | Experimental | Behavioral: Bundled, Behavioral: Dose 12, Behavioral: RPNPatients 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 |
| 17: Bundled, PPN, CA1 | Experimental | Behavioral: Bundled, Behavioral: Dose 1, Behavioral: PPNPatients 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 |
| 18: Bundled, PPN, CA3 | Experimental | Behavioral: Bundled, Behavioral: Dose 3, Behavioral: PPNPatients 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 |
| 19: Bundled, PPN, CA6 | Experimental | Behavioral: Bundled, Behavioral: Dose 6, Behavioral: PPNPatients 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 |
| 20: Bundled, PPN, CA9 | Experimental | Behavioral: Bundled, Behavioral: Dose 9, Behavioral: PPNPatients 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 |
| 21: Bundled, PPN, CA12 | Experimental | Behavioral: Bundled, Behavioral: Dose 12, Behavioral: PPNPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Speak English or Spanish
- Currently use tobacco
- Live in a persistent poverty census tract
- Present at participating clinics
Key exclusion criteria (1 listed)
- Opt-out of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic Level: AAC - SDOH, AAC - TobaccoAsk-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). | Behavioural | 1: Clinic Level Intervention Only |
| Non-BundledAll patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services. | Behavioural | 10: Non-Bundled, PPN Dose, CA9, 11: Non-Bundled, PPN Dose, CA12, 2: Non-Bundled, RPN, CA1, 3: Non-Bundled, RPN, CA3, 4: Non-Bundled, RPN, CA6, 5: Non-Bundled, RPN, CA9, 6: Non-Bundled, RPN, CA12, 7: Non-Bundled, PPN Dose, CA1, 8: Non-Bundled, PPN Dose, CA3, 9: Non-Bundled, PPN Dose, CA6 |
| BundledAll patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH. | Behavioural | 12: Bundled, RPN, CA1, 13: Bundled, RPN, CA3, 14: Bundled, RPN, CA6, 15: Bundled, RPN, CA9, 16: Bundled, RPN, CA12, 17: Bundled, PPN, CA1, 18: Bundled, PPN, CA3, 19: Bundled, PPN, CA6, 20: Bundled, PPN, CA9, 21: Bundled, PPN, CA12 |
| Dose 1The 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. | Behavioural | 12: Bundled, RPN, CA1, 17: Bundled, PPN, CA1, 2: Non-Bundled, RPN, CA1, 7: Non-Bundled, PPN Dose, CA1 |
| Dose 3The 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. | Behavioural | 13: Bundled, RPN, CA3, 18: Bundled, PPN, CA3, 3: Non-Bundled, RPN, CA3, 8: Non-Bundled, PPN Dose, CA3 |
| Dose 6The 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. | Behavioural | 14: Bundled, RPN, CA6, 19: Bundled, PPN, CA6, 4: Non-Bundled, RPN, CA6, 9: Non-Bundled, PPN Dose, CA6 |
| Dose 9The 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. | Behavioural | 10: Non-Bundled, PPN Dose, CA9, 15: Bundled, RPN, CA9, 20: Bundled, PPN, CA9, 5: Non-Bundled, RPN, CA9 |
| Dose 12The 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. | Behavioural | 11: Non-Bundled, PPN Dose, CA12, 16: Bundled, RPN, CA12, 21: Bundled, PPN, CA12, 6: Non-Bundled, RPN, CA12 |
| RPNReactive 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. | Behavioural | 12: Bundled, RPN, CA1, 13: Bundled, RPN, CA3, 14: Bundled, RPN, CA6, 15: Bundled, RPN, CA9, 16: Bundled, RPN, CA12, 2: Non-Bundled, RPN, CA1, 3: Non-Bundled, RPN, CA3, 4: Non-Bundled, RPN, CA6, 5: Non-Bundled, RPN, CA9, 6: Non-Bundled, RPN, CA12 |
| PPNProactive Patient Navigation (PPN): Patient is proactively called, over 12 months following a patient's initial clinic visit, by a CHW up to 4 times. | Behavioural | 10: Non-Bundled, PPN Dose, CA9, 11: Non-Bundled, PPN Dose, CA12, 17: Bundled, PPN, CA1, 18: Bundled, PPN, CA3, 19: Bundled, PPN, CA6, 20: Bundled, PPN, CA9, 21: Bundled, PPN, CA12, 7: Non-Bundled, PPN Dose, CA1, 8: Non-Bundled, PPN Dose, CA3, 9: Non-Bundled, PPN Dose, CA6 |
Primary outcome
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.
7 secondary outcomes
Association between patient and clinic level predictor variables
Time frame: 12 Months
Reach -- SDOH
Time frame: Up to 12 months after enrollment in study.
Patient Abstinence
Time frame: Up to 12 months after study enrollment
Reach - Offer
Time frame: Up to 12 months after study enrollment
Reach -- Connect
Time frame: Up to 12 months after study enrollment
Patient Engagement
Time frame: Up to 12 months after study enrollment
Cost-Effectiveness
Time frame: Up to 12 months after study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chelsey Schlechter, MPH, PhD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic Level: AAC - SDOH, AAC - Tobacco, Non-Bundled and Bundled in people with Tobacco Use Cessation and Tobacco Use, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsey Schlechter, PhD (801-213-5704, chelsey.schlechter@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of the Quit Services (time frame: up to 12 months after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.