Optimizing Pregnancy and Treatment Interventions for Moms 2.0

公开摘要 孕妇中的阿片类药物使用障碍（OUD）会对婴儿造成许多不良后果， 母亲，包括：早产，低出生体重，出生缺陷，新生儿禁欲综合征（NAS），和齿轮， 儿童的肥胖缺陷。OUD孕妇的HIV/HCV感染率升高，精神疾病， 非阿片类物质使用障碍（SUD）;以及社会，财务和就业问题。怀孕 在过去十年中，患有OUD的妇女接受治疗的人数也急剧增加。不幸的是， 患有OUD的孕妇也有很高的治疗退出率。虽然药物辅助治疗可以... 结合心理社会服务是阿片类药物依赖孕妇的护理标准，目前尚不清楚 哪种社会心理服务是最佳的一种有希望的干预措施是患者导航（PN），这是一种基于证据的 实践证明对各种心理/社会/情感结果有效。PN已被证明受益于 OUD患者常见的问题，包括获得治疗、参与护理以及 改善健康行为。目前的研究将在我们初步研究的基础上，进一步建立内部 这些发现的外部效度和PN干预的潜在价值。第一个具体目标是 该项目将涉及使用马拉特和戈登的复发预防模型，其中我们将注入复发预防， 内容识别/预防（1）高风险的情况下停药辅助治疗- （2）初次禁欲。这个项目的第二个具体目标将涉及扩大我们的证明- 概念研究干预和方案，以促进多中心、随机、全系统试验;这将 包括统一干预、招募、随机化、研究人员设盲、正式随访程序 和员工培训材料。该项目的第三个具体目标将涉及实施和测试前- 在两个医院地点，Magee-Wom，对OUD孕妇（n = 122）进行了扩展干预和方案， 北医学院附属医院和犹他州大学医院。受试者将被随机分配至PN组或标准组 护理，并将在基线、分娩前以及产后2个月和6个月进行评估。完成本项目 将产生必要的协议/程序和试验数据，为大规模、全功率、多站点 随机试验这项工作解决了一个主要的公共卫生问题，怀孕期间的阿片类药物依赖， 为保护母婴健康进一步建立了证据基础。

PUBLIC ABSTRACT Opioid use disorder (OUD) among pregnant women results in a number of adverse consequences in infants and mothers, including: preterm birth, low birth weight, birth defects, neonatal abstinence syndrome (NAS), and cog- nitive deficits in children. Pregnant women with OUD have elevated rates of HIV/HCV infection, psychiatric dis- orders, non-opioid substance use disorder (SUD); and social, financial, and employment problems. Pregnant women with OUD also have had sharp increases in treatment admissions in the last decade. Unfortunately, pregnant women with OUD also have high rates of treatment dropout. While medication assisted treatment com- bined with psychosocial services is the standard of care for opioid dependent pregnant women, it is not clear which psychosocial service is optimal. One promising intervention is patient navigation (PN), an evidence-based practice shown to be effective for a variety of psycho/social/emotional outcomes. PN has been shown to benefit problems common in those with OUD, including access to treatment, engagement in care, and motivation to improve health behaviors. The current study will build on our preliminary studies and further establish the internal and external validity of these findings and the potential value of the PN intervention. The first Specific Aim of this project will involve using Marlatt and Gordon’s relapse prevention model wherein we will infuse relapse preven- tion content for identification/prevention of (1) high risk situations of discontinuance of medication assisted treat- ment and (2) initial abstinence lapses. The second Specific Aim of this project will involve expanding our proof- of-concept study intervention and protocols to facilitate a multisite, randomized, system-wide trial; which will include uniform intervention, recruitment, randomization, study staff blinding, formalized follow up procedures, and staff training materials. The third Specific Aim of this project will involve implementing and testing the ex- panded intervention and protocols with pregnant women with OUD (n=122) at two hospital sites, Magee-Wom- ens Hospital of UPMC and the University of Utah Hospital. Participants will be randomized to PN or standard care and will be assessed at baseline, prior to delivery, and 2 and 6 months postnatal. Completion of this project will result in necessary protocols/procedures and pilot data preparatory to a large scale, fully powered, multisite randomized trial. This work addresses a major public health issue, opioid dependence during pregnancy, and further establishes an evidence base for protecting health of mother and baby.