Effective Caregiving for Neonatal Abstinence Syndrome: Development of an Instructional Mobile Technology Platform for High-Risk Pregnant Women

新生儿禁欲综合症的有效护理：为高危孕妇开发教学移动技术平台

• 批准号: 10039798
• 负责人: Ekaterina Burduli
• 金额: $ 15.82万
• 依托单位: WASHINGTON STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10039798
• 关键词: Address; Admission activity; Affect; Alcohol or Other Drugs use; American College of Obstetricians and Gynecologists; Anxiety; Birth; Body Weight decreased; Breast Feeding; Caregivers; Caring; Child; Clinical Trials; Consultations; Cues; Data; Development; Discipline of obstetrics; Eating; Education; Environment; Epidemiology; Feeling; Fever; Future; General Population; Goals; Health; Health Technology; Hospitals; Industry; Industry Collaboration; Infant Care; Instruction; Intervention; Interview; Lead; Learning; Learning Module; Length; Length of Stay; Maternal Health; Mental Depression; Mentored Research Scientist Development Award; Mentors; Mentorship; Modeling; Modification; Mothers; National Institute of Drug Abuse; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Neonatology; Newborn Infant; Outcome; Perception; Pharmacology; Pilot Projects; Positioning Attribute; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Provider; Randomized; Readiness; Recommendation; Recovery; Relapse; Research; Research Personnel; Research Support; Risk; Safety; Shapes; Sleep; Stress; Structure; Substance Use Disorder; Surveys; Sweating; Symptoms; Testing; Training; Training Activity; Tremor; Woman; Work; analog; arm; base; care providers; career; career development; caregiver education; caregiving; clinical implementation; design; drug relapse; efficacy testing; evidence base; experience; feeding; follow-up; high risk; high risk population; high standard; hospital readmission; illicit opioid; improved; innovation; interactive tool; mHealth; maternal risk; mobile computing; obstetric care; opioid agonist therapy; opioid treatment program; opioid use; opioid use disorder; opioid withdrawal; perinatal women; pregnant; prescription opioid; prevent; product development; programs; readmission rates; skills; skills training; sucking; tool; treatment adherence; treatment arm; treatment as usual; usability; virtual

ABSTRACT Due to an alarming rise in opioid use among the general population that is mirrored in pregnant women, Neonatal Abstinence Syndrome (NAS) rates have increased in the US from 2004 to 2014. Most newborns experiencing NAS require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. Facilitating postpartum maternal-newborn involvement is critical in preventing further adverse maternal-newborn outcomes. To achieve positive maternal-newborn involvement, mothers need to learn effective caregiving NAS strategies while they are pregnant. Surprisingly, current obstetrical practice standards for high risk pregnant women do not address this pressing need, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. To address this critical gap, I propose to adapt an existing mobile NAS tool for clinician training and decision support, for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial. First, I will conduct semi- structured interviews with a panel of neonatology experts, NAS care providers, and mothers with NAS-affected babies to gather their recommendations on management of NAS and explore their perspectives on the care of these newborns. Findings will guide the adaptation of the existing mobile NAS tool for high-risk pregnant women. I will then test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with 10 pregnant women receiving opioid agonist therapy (OAT) at Spokane Regional Health District’s Opioid Treatment Program and Evergreen Recovery Center. Finally, we will randomize 30 high-risk pregnant women seen at these facilities to either receive the adapted mobile NAS caregiving tool or usual care. We will compare these mothers on maternal drug relapse and OAT continuation, maternal-newborn bonding, length of newborn hospital stays, readmissions rates, breastfeeding initiation and duration, and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum. Findings will serve as pilot data for a subsequent large R01 randomized controlled analog trial testing the efficacy of the adapted NAS caregiving tool in reducing poor outcomes for NAS-affected newborns and their mothers. My proposed research plan integrates activities, formal training, and mentorship from experts (Drs. Sterling McPherson, Hendree Jones, John Roll, Celestina Barbosa-Leiker, and Kim Johnson) in development, testing and implementation of substance use disorder treatment for perinatal women, mobile health interventions, and implementation of clinical trials in perinatal women with substance use disorders. This Mentored Research Scientist Development Award (K01) will build upon my previous training and allow me to pursue my long-term career goal of becoming an independent investigator with an established program of research focused on the development, implementation, and testing of interventions for substance using perinatal women and reduction of poor health outcomes for substance using perinatal women and their newborns.

摘要 由于一般人群中阿片类药物使用的惊人增加，反映在孕妇中， 从2004年到2014年，美国的戒断综合征（NAS）发病率有所上升。大多数新生儿 NAS需要非药物治疗，最重要的是，需要母亲参与新生儿。 促进产后母-新生儿参与对于预防进一步的不良母-新生儿关系至关重要 结果。为了实现积极的母婴参与，母亲需要学习有效的应对NAS 在怀孕期间的策略。令人惊讶的是，目前高危孕妇的产科实践标准 妇女没有解决这一迫切需要，部分原因是没有干预措施为未来的母亲做好准备 照顾有NAS风险的新生儿的挑战。为了解决这一关键差距，我建议调整一个 现有的移动的NAS工具，用于高危孕妇的临床医生培训和决策支持，并评估其 小型随机对照模拟试验中的可用性、可接受性和可行性。首先，我将进行半- 对一组生殖病学专家、NAS护理提供者和受NAS影响的母亲进行了结构化访谈， 收集他们对NAS管理的建议，并探讨他们对护理的看法， 这些新生儿调查结果将指导现有的移动的NAS工具的适应高风险孕妇。 然后，我将通过对10名孕妇的调查来测试适应移动的工具的可用性、可接受性和可行性。 在斯波坎地区卫生区阿片类药物治疗项目中接受阿片类药物激动剂治疗（OAT）的妇女 和万年青康复中心最后，我们将随机抽取30名在这些机构就诊的高危孕妇 以接收适配的移动的NAS部署工具或常规护理。我们将比较这些母亲 母亲药物复发和OAT继续，母亲-新生儿结合，新生儿住院时间， 再入院率，母乳喂养开始和持续时间，以及4岁、8岁和12岁时的产后抑郁和焦虑 产后几周研究结果将作为后续大型R 01随机对照类似物的试验数据 一项试验，测试适应性NAS评估工具在减少NAS影响患者不良结局方面的疗效 新生儿和他们的母亲我提出的研究计划整合了活动、正式培训和指导 来自专家（Sterling麦克弗森、Hendree Jones、John Roll、Celestina Barbosa-Leiker和Kim约翰逊博士） 在为围产期妇女制定、测试和实施药物使用障碍治疗方面，移动的 健康干预措施，并在患有药物使用障碍的围产期妇女中开展临床试验。这 指导研究科学家发展奖（K 01）将建立在我以前的培训，让我 追求我的长期职业目标，成为一名独立的调查员， 研究的重点是制定、实施和测试围产期使用物质的干预措施， 减少使用药物的围产期妇女及其新生儿的不良健康后果。