Reach Through Equitable Implementation in Utah

NCT06881069 | Recruiting DMC

• 2 other identifiers: HCI1652885U54CA280812-02
• Study Type: interventional
• Target: 1,560
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Tobacco Use Cessation; Tobacco Use; Tobacco Smoking; Tobacco Chewing; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Reach of the Quit Services

  Reach of the Quit Services is the number of eligible patients who officially enroll in the Quit Services over the total number of eligible patients.

  up to 12 months after study enrollment

Secondary Outcomes (7)

• Association between patient and clinic level predictor variables

  12 Months

• Reach -- SDOH

  Up to 12 months after enrollment in study.

• Patient Abstinence

  Up to 12 months after study enrollment

• Reach - Offer

  Up to 12 months after study enrollment

• Reach -- Connect

  Up to 12 months after study enrollment

Study Arms (21)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Behavioral: Bundled; Behavioral: Dose 12; Behavioral: PPN

Interventions

Clinic Level: AAC - SDOH, AAC - Tobacco BEHAVIORAL

Ask-Advise-Connect (AAC) is a health information technology (HIT) implementation strategy that consists of EHR-based point-of-care supports for the assessment of tobacco use and Social Drivers of Health (SDOH).

1: Clinic Level Intervention Only

Non-Bundled BEHAVIORAL

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

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

Bundled BEHAVIORAL

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

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 1 BEHAVIORAL

The number of proactive outreach opportunities for CA the patient receives. Patient will receive 1 opportunity for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.

12: Bundled, RPN, CA1; 17: Bundled, PPN, CA1; 2: Non-Bundled, RPN, CA1; 7: Non-Bundled, PPN Dose, CA1

Dose 3 BEHAVIORAL

The number of proactive outreach opportunities for CA the patient receives. Patient will receive 3 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.

13: Bundled, RPN, CA3; 18: Bundled, PPN, CA3; 3: Non-Bundled, RPN, CA3; 8: Non-Bundled, PPN Dose, CA3

Dose 6 BEHAVIORAL

The number of proactive outreach opportunities for CA the patient receives. Patient will receive 6 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.

14: Bundled, RPN, CA6; 19: Bundled, PPN, CA6; 4: Non-Bundled, RPN, CA6; 9: Non-Bundled, PPN Dose, CA6

Dose 9 BEHAVIORAL

The number of proactive outreach opportunities for CA the patient receives. Patient will receive 9 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.

10: Non-Bundled, PPN Dose, CA9; 15: Bundled, RPN, CA9; 20: Bundled, PPN, CA9; 5: Non-Bundled, RPN, CA9

Dose 12 BEHAVIORAL

The number of proactive outreach opportunities for CA the patient receives. Patient will receive 12 opportunities for CA, over 12 months following a patient's initial clinic visit, that includes a simple one-touch response to directly connect to the Quit Services or the CHW.

11: Non-Bundled, PPN Dose, CA12; 16: Bundled, RPN, CA12; 21: Bundled, PPN, CA12; 6: Non-Bundled, RPN, CA12

RPN BEHAVIORAL

Reactive Patient Navigation Only (RPN): Patient can request to speak to a CHW, over 12 months following a patient's initial clinic visit, at any time.

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

PPN BEHAVIORAL

Proactive Patient Navigation (PPN): Patient is proactively called, over 12 months following a patient's initial clinic visit, by a CHW up to 4 times.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Opt-out of study

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use; Tobacco Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Chelsey Schlechter, MPH, PhD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsey Schlechter, PhD

CONTACT

801-213-5704; chelsey.schlechter@hci.utah.edu

Chelsey Schlechter, MPH, PhD

CONTACT

801-213-5704; chelsey.schlechter@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

US (1)