Clinical trial NCT06881069: Reach Through Equitable Implementation in Utah
Official title: Reach Through Equitable Implementation in Utah (REI-UT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Tobacco Use
Tobacco Smoking
Tobacco Chewing
Tobacco Dependence
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-03-18
Enrollment: 1560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Reach of the Quit Services
timeFrame: up to 12 months after study enrollment
Secondary outcomes:
measure: Association between patient and clinic level predictor variables
timeFrame: 12 Months
measure: Reach -- SDOH
timeFrame: Up to 12 months after enrollment in study.
measure: Patient Abstinence
timeFrame: Up to 12 months after study enrollment
measure: Reach - Offer
timeFrame: Up to 12 months after study enrollment
measure: Reach -- Connect
timeFrame: Up to 12 months after study enrollment
measure: Patient Engagement
timeFrame: Up to 12 months after study enrollment
measure: Cost-Effectiveness
timeFrame: Up to 12 months after study enrollment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Chelsey Schlechter, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: