CHOICES+: Preconception approach to reducing alcohol & tobacco-exposed pregnancy

描述（由申请人提供）：育龄妇女饮酒问题日益受到关注。研究估计，50%的18-44岁女性在上个月饮酒，12.5%的人报告酗酒。由于大约50%的怀孕是计划外的，许多妇女直到怀孕后几周甚至几个月才意识到自己怀孕了，胎儿酒精暴露可能发生在怀孕早期，这是对酒精影响敏感性增加的关键时期。此外，一项关于预防酒精暴露妊娠（AEP）的先入之见方法的研究发现，超过70%的AEP风险女性是吸烟者。鉴于大量证据证明了怀孕期间吸烟的有害影响，减少AEP和促进其他健康产前行为的干预措施也应针对戒烟。 这项随机对照研究，Project CHOICES+，将确定Project CHOICES干预加上循证戒烟计划在降低酒精和烟草暴露妊娠风险方面的有效性。具体而言，我们将检查与治疗作为替代疗法（TAU）相比，项目选择+干预的效果：将酒精使用减少到既定风险水平以下;增加有效避孕的一致使用;增加戒烟治疗的参与和增加戒烟。此外，我们对选择+干预的增量成本的审查（例如，工作人员的时间、材料、行政服务、干预前后的总医疗费用）将为未来的成本/效益分析提供基础，该分析将告知政策制定者和医疗保健组织实施项目CHOICES+的潜在效益。 项目选择+将在哈里斯县医院区（HCHD）的两家医院和11个社区卫生诊所实施，哈里斯县医院区是为美国第三大人口县哈里斯县约386万居民提供服务的公共医疗保健系统。HCHD的综合电子医疗记录（EMR）系统将被用来促进筛查，干预和后续工作。我们经验丰富的多学科团队由最初的CHOICES项目研究的德克萨斯州研究中心的主要研究者领导。它还包括HCHD医生和管理人员，他们将确保项目的实施和融入标准医疗保健。我们在HCHD和其他医疗保健系统内实施计划的强大历史将使我们能够与家庭医学，妇科，精神病学，护理，行为健康和其他关键部门密切合作，以确保成功实施研究。这项研究的结果将为促进健康的产前行为和减少酒精和烟草暴露妊娠的流行提供信息和推动未来的努力。

DESCRIPTION (provided by applicant): There is growing concern about alcohol consumption among women of childbearing age. Studies have estimated that 50% of women, ages 18-44, used alcohol and 12.5 % reported binge drinking in the last month. Because approximately 50% of pregnancies are unplanned and many women do not realize they are pregnant until several weeks or even months after conception, fetal alcohol exposure may occur early in pregnancy, a critical time of increased susceptibility to the effects of alcohol. In addition, Project CHOICES, a study of a preconceptional approach to preventing alcohol-exposed pregnancies (AEP), found that over 70% of the women at risk of AEP were smokers. Given that a substantive body of evidence documents the deleterious effects of smoking while pregnant, interventions to reduce AEP and promote other healthy prenatal behaviors should also target smoking cessation. This randomized controlled study, Project CHOICES+, will determine the efficacy of the Project CHOICES intervention plus a referral to an evidence-based smoking cessation program in reducing the risk of alcohol and tobacco exposed pregnancies. Specifically, we will examine the effect of the Project CHOICES+ intervention compared to Treatment as Usual (TAU) in: reducing alcohol use below established risk levels; increasing consistent use of effective contraception; increasing engagement in smoking cessation treatment and increasing smoking cessation. In addition, our examination of the incremental costs of the CHOICES + intervention (e.g., staff time, materials, administrative services, total medical charges pre- and postintervention) will provide a basis for future cost/benefit analyses that will inform policymakers and healthcare organizations of the potential benefits of implementing Project CHOICES+. Project CHOICES+ will be implemented in the two hospitals and 11 community health clinics of Harris County Hospital District (HCHD), the public healthcare system that serves the approximately 3.86 million residents of Harris County, Texas, the third most populous county in the United States. HCHD's comprehensive electronic medical record (EMR) system will be utilized to facilitate screening, intervention and follow up efforts. Our experienced, multidisciplinary team headed is by the primary investigators from the Texas site of the original Project CHOICES study. It also includes HCHD physicians and administrators who will assure project implementation and integration into standard medical care. Our strong history of implementing programs within HCHD and other healthcare systems will enable us to work closely with family medicine, gynecology, psychiatry, nursing, behavioral health, and other key units to assure successful study implementation. Results from this study will inform and advance future efforts in the service of promoting healthy prenatal behavior and reducing the prevalence of alcohol and tobacco-exposed pregnancies.