Improving alcohol and substance use care access, outcomes, and equity during the reproductive years: A Type 1 Hybrid Trial in Family Planning Clinics

危险酒精和药物使用以及酒精和物质使用障碍（AUDs/SUDs）的比率最高， 与生命历程的其他阶段相比，妇女在生育期的生活水平更高。AUD和SUD是 与重大和终身的行为，心理，身体，性和生殖健康（SRH） 对妇女造成的后果，以及对在种族和族裔上属于少数群体的妇女和生活在 贫穷。迫切需要创新的方法来解决预防中的酒精和药物使用问题。 医疗保健设置。计划生育（FP）诊所是一个值得信赖的护理来源和主要接入点， 妇女和作为一个安全网结构边缘化群体在美国FP诊所是独特的良好- 适用于实施和扩大综合酒精/药物使用服务的背景，但完全没有得到充分研究。 虽然筛查、短暂干预和转诊治疗（SBIRT）是一种被广泛接受的循证医学方法， 在初级保健和心理健康环境中对酒精使用的干预，对促进者和 在FP诊所接受和维持SBIRT的障碍。对远程医疗的了解更少， 作为SBIRT交付平台，该平台已在COVID-19疫情期间迅速推出。此外，几乎没有证据表明 存在有效的组织层面的实施战略，以加速SBIRT在FP中的采用。 我们提出了一个解释性的，顺序的，混合的方法研究，以评估SBIRT在一个扩展的FP 一个国家性健康和生殖健康组织的诊所网络-一个新颖的、具有高度影响力的环境， 和处于社会不利地位的育龄妇女人口，这些人口面临AUD/SUD的最大风险。 我们的综合研究借鉴了循证实施方法，实施和 在执行研究综合框架的指导下， 覆盖、有效性、采用、实施和维护模型。目标1：确定具体目标 为了实施、维持和扩大SBIRT，我们将与诊所进行行政调查 利益相关者（诊所主任、提供者和工作人员n = 153）和与利益相关者的关键知情人访谈， 患者（n = 40）调查组织的做法和观点，酒精和物质相关的 服务在目标2中，我们将进行双随机1型混合动力系统的重复性-实现试验测试 SBIRT（面对面和远程医疗）与常规护理，在一个大的，高容量的东北附属公司， 国家组织。我们将在4个诊所随机抽取600名患者，收集患者层面的酒精数据 和物质使用的主要有效性结果，以及次要的性健康和生殖健康，心理/身体健康，质量 在基线、30天和3个月时的生命和健康结局。目标3将探讨促进因素和障碍 通过调查和与诊所主任的访谈，了解SBIRT的采用情况和ISF的实施策略， 提供者、工作人员（n = 20）和患者（n = 20）电子病历。结果将提供新的，及时的 提供证据，为在全国范围内扩大计划生育环境中与酒精和药物有关的服务提供信息。

Rates of risky alcohol and drug use and alcohol and substance use disorders (AUDs/SUDs) are highest among women during their reproductive years compared to other periods of the life course. AUDs and SUDs are associated with significant and lifelong behavioral, mental, physical, and sexual and reproductive health (SRH) consequences for women and disproportionately for racially and ethnically minoritized women and those living in poverty. There is an urgent need for innovative methods to address alcohol and substance use in preventive healthcare settings. Family planning (FP) clinics are a trusted care source and primary point of access for women and serve as a safety net for structurally marginalized groups in the U.S. FP clinics are uniquely well- suited, but entirely understudied, contexts for implementing and scaling integrated alcohol/drug use services. While screening, brief intervention, and referral to treatment (SBIRT) is a widely accepted, evidence-based intervention for alcohol use in primary care and mental health settings, little is known about the facilitators and barriers to the uptake and sustainment of SBIRT in FP clinics. Even less is understood about telemedicine, which has been rapidly rolled out for COVID-19, as a SBIRT delivery platform. Further, virtually no evidence exists on effective organizational level implementation strategies to accelerate SBIRT’s adoption in FP. We propose an explanatory, sequential, mixed methods study to evaluate SBIRT in an expansive FP clinic network of a national SRH organization – a novel and highly impactful setting with a reach of a diverse and largely socially disadvantaged population of reproductive-aged women at greatest risk for AUDs/SUDs. Our integrated study draws upon the evidence-based implementation approach, Implementation and Sustainment Facilitation (ISF), guided by the Consolidated Framework for Implementation Research and Reach, Effectiveness, Adoption, Implementation and Maintenance models. In Aim 1, to identify specific targets for implementation, sustainment, and scale-up of SBIRT, we will conduct administrative surveys with clinic stakeholders (clinic directors, providers, and staff n=153) and key informant interviews with stakeholders and patients (n=40) to investigate organizational practices and perspectives on alcohol- and substance-related services. In Aim 2, we will conduct a dual randomized Type 1 Hybrid Effectiveness-Implementation trial testing SBIRT (in-person and telemedicine) vs. usual care, within a large, high-volume Northeastern affiliate of the national organization. We will randomize 600 patients across 4 clinics, collecting patient level data on alcohol and substance use primary effectiveness outcomes, as well as secondary SRH, mental/physical health, quality of life, and wellbeing outcomes at baseline, 30 days, and 3 months. Aim 3 will explore facilitators and barriers to SBIRT adoption and the ISF implementation strategy via surveys and interviews with clinic directors, providers, and staff (n=20) and patients (n=20) electronic medical records. Results will provide new, timely evidence to inform scale-up of alcohol and substance related services in FP settings nationally.