Reach Through Equitable Implementation in Utah (REI-UT)

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Tobacco Dependence; Tobacco Chewing; Tobacco Use Cessation; Tobacco Smoking; Tobacco Use

Treatments: Behavioral: RPN; Behavioral: Dose 1; Behavioral: Dose 6; Behavioral: Dose 9; Behavioral: Dose 12; Behavioral: Clinic Level: AAC - SDOH, AAC - Tobacco; Behavioral: Non-Bundled; Behavioral: Bundled; Behavioral: PPN; Behavioral: Dose 3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06881069

HCI165288

5U54CA280812-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,560 participants in 21 patient groups

1: Clinic Level Intervention Only

Other group

Description:

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

Treatment:

Behavioral: Clinic Level: AAC - SDOH, AAC - Tobacco

2: Non-Bundled, RPN, CA1

Experimental group

Description:

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

Treatment:

Behavioral: Non-Bundled

Behavioral: Dose 1

Behavioral: RPN

3: Non-Bundled, RPN, CA3

Experimental group

Description:

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

Treatment:

Behavioral: Dose 3

Behavioral: Non-Bundled

Behavioral: RPN

4: Non-Bundled, RPN, CA6

Experimental group

Description:

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

Treatment:

Behavioral: Non-Bundled

Behavioral: Dose 6

Behavioral: RPN

5: Non-Bundled, RPN, CA9

Experimental group

Description:

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

Treatment:

Behavioral: Non-Bundled

Behavioral: Dose 9

Behavioral: RPN

6: Non-Bundled, RPN, CA12

Experimental group

Description:

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

Treatment:

Behavioral: Non-Bundled

Behavioral: Dose 12

Behavioral: RPN

7: Non-Bundled, PPN Dose, CA1

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Non-Bundled

Behavioral: Dose 1

8: Non-Bundled, PPN Dose, CA3

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Dose 3

Behavioral: Non-Bundled

9: Non-Bundled, PPN Dose, CA6

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Non-Bundled

Behavioral: Dose 6

10: Non-Bundled, PPN Dose, CA9

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Non-Bundled

Behavioral: Dose 9

11: Non-Bundled, PPN Dose, CA12

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Non-Bundled

Behavioral: Dose 12

12: Bundled, RPN, CA1

Experimental group

Description:

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

Treatment:

Behavioral: Bundled

Behavioral: Dose 1

Behavioral: RPN

13: Bundled, RPN, CA3

Experimental group

Description:

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

Treatment:

Behavioral: Dose 3

Behavioral: Bundled

Behavioral: RPN

14: Bundled, RPN, CA6

Experimental group

Description:

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

Treatment:

Behavioral: Bundled

Behavioral: Dose 6

Behavioral: RPN

15: Bundled, RPN, CA9

Experimental group

Description:

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

Treatment:

Behavioral: Bundled

Behavioral: Dose 9

Behavioral: RPN

16: Bundled, RPN, CA12

Experimental group

Description:

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

Treatment:

Behavioral: Bundled

Behavioral: Dose 12

Behavioral: RPN

17: Bundled, PPN, CA1

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Bundled

Behavioral: Dose 1

18: Bundled, PPN, CA3

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Dose 3

Behavioral: Bundled

19: Bundled, PPN, CA6

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Bundled

Behavioral: Dose 6

20: Bundled, PPN, CA9

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Bundled

Behavioral: Dose 9

21: Bundled, PPN, CA12

Experimental group

Description:

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

Treatment:

Behavioral: PPN

Behavioral: Bundled

Behavioral: Dose 12