Reach Through Equitable Implementation in Utah

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).

• 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).
• Non-Bundled (Behavioral): All patient level strategies will address only the content of increasing reach of the Utah Tobacco Quit Services.
• Bundled (Behavioral): All patient level strategies will address the content of increasing reach of the Utah Tobacco Quit Services and SDOH.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Primary outcomes

• Reach of the Quit Services [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.

Secondary outcomes

• Association between patient and clinic level predictor variables [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.
• Reach -- SDOH [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)
• Patient Abstinence [Up to 12 months after study enrollment]: Proportion of patients who report 7 or 30 day abstinence among those sampled.
• Reach - Offer [Up to 12 months after study enrollment]: Proportion of patients offered connection to Quit Services/total patients offered connection to Quit Services.
• Reach -- Connect [Up to 12 months after study enrollment]: Proportion of patients who accept connection to Quit Services out of eligible patients
• Patient Engagement [Up to 12 months after study enrollment]: Proportion of patients who interact with CA or PN out of eligible patients.
• Cost-Effectiveness [Up to 12 months after study enrollment]: Cost-effectiveness of strategies

Sex: All, ages: 18 Years to any

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

• Chelsey Schlechter, MPH, PhD, Principal investigator, Huntsman Cancer Institute

NIH grants: U54CA280812