Reach Through Equitable Implementation in Utah (REI-UT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,560
- 试验地点
- 2
- 主要终点
- Reach of the Quit Services
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •Opt-out of study
结局指标
主要结局
Reach of the Quit Services
时间窗: 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.
次要结局
- 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)
- Patient Engagement(Up to 12 months after study enrollment)
- Cost-Effectiveness(Up to 12 months after study enrollment)