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

危险的酒精和药物使用以及酒精和物质使用障碍(AUDS/SODS)的比率是最高的 与生命过程中的其他时期相比，妇女在其生育年龄段中的性别差异更大。AUD和肥皂水是 与重要的和终身的行为、心理、身体、性和生殖健康(SRH)相关 对妇女的影响，特别是对种族和族裔分化的妇女和那些生活在 在贫困中。迫切需要有创新的方法来解决酒精和物质在预防中的使用问题 医疗保健设置。计划生育(FP)诊所是值得信赖的护理来源和主要接入点 女性，并为美国计划生育诊所的结构性边缘化群体提供安全网，这是独一无二的 实施和推广综合酒精/药物使用服务的适当但完全未得到充分研究的环境。 虽然筛查、短期干预和转诊治疗(SBIRT)是被广泛接受的、基于证据的 在初级保健和精神卫生环境中对酒精使用的干预，对促进者和 计划生育门诊接受和维持SBIRT的障碍。对远程医疗的了解就更少了， 作为SBIRT的交付平台，它已经为新冠肺炎迅速推出。此外，几乎没有证据表明 在组织层面上存在有效的实施战略，以加速SBIRT在FP中的采用。 我们提出了一种解释性的、顺序的、混合的方法来评估膨胀性FP中的SBIRT。 全国性SRH组织的诊所网络-一个新颖且极具影响力的环境，覆盖范围广泛 以及在很大程度上处于社会不利地位的育龄妇女，他们患上尿毒症/肥皂症的风险最大。 我们的综合研究借鉴了以证据为基础的实施方法、实施和 执行研究和执行综合框架指导下的促进维持 覆盖范围、有效性、采用、实施和维护模式。在目标1中，确定特定目标 为了实施、支持和扩大SBIRT，我们将与诊所进行行政调查 利益相关者(诊所主任、提供者和员工n=153)和主要线人与利益相关者和 患者(n=40)调查酒精和物质相关的组织实践和观点 服务。在目标2中，我们将进行双随机类型1混合有效性-实施试验测试 SBIRT(面对面和远程医疗)与常规护理相比，在大型、高容量的东北分公司内 国家组织。我们将对4家诊所的600名患者进行随机抽样，收集有关酒精的患者水平数据 和物质使用的主要效果结果，以及次要的SRH、心理/身体健康、质量 在基线、30天和3个月时的生命和幸福感结果。目标3将探索促进者和障碍 通过调查和与诊所主任的访谈，了解SBIRT的采用和ISF的实施战略， 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 在全国范围内扩大与酒精和物质相关的服务的证据。

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.