HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial Clinical Site

HEAL Initiative：新生儿阿片类药物戒断综合征药物治疗效果比较试验临床站点

• 批准号: 10380359
• 负责人: RICHARD Whittington HALL
• 金额: $ 45.59万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380359
• 关键词: 2 year old; Academic support; Admission activity; African American; Alabama; Area; Arkansas; Awareness; Beds; Behavioral; Blood specimen; Brain; Buprenorphine; Caring; Case Manager; Child; Childhood; Clinic; Clinical; Clinical Research; Clinical and Translational Science Awards; Communities; Complex; Data; Data Coordinating Center; Development; Discipline of obstetrics; Dose; Drug Kinetics; Electronic Mail; Enrollment; Ensure; Environment; Exposure to; Faculty; Family; Funding; Head; Helping to End Addiction Long-term; Hispanics; Home; Hospitals; Incentives; Infant; Infrastructure; Insurance; Leadership; Length of Stay; Long-Term Effects; Medical; Mental Health; Methadone; Mission; Modeling; Morphine; Mothers; Multicenter Trials; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Neonatology; Newborn Infant; Opioid; Outcome; Outpatients; Pain; Parents; Participant; Patients; Pediatric Hospitals; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Policies; Population; Positioning Attribute; Pregnant Women; Privatization; Prospective cohort study; Protocols documentation; Provider; Psychiatry; Psychometrics; Publications; Research; Research Institute; Research Personnel; Rural; Rural Population; Sample Size; Schedule; Science; Sister; Site; Substance Use Disorder; Telemedicine; Testing; Time; Translational Research; Travel; Treatment Cost; United States National Institutes of Health; Universities; Update; Weaning; Woman; Women' s Health; Work; adverse childhood events; antenatal; arm; clinical research site; comparative effectiveness trial; compare effectiveness; effectiveness clinical trial; effectiveness evaluation; environmental stressor; evidence base; experience; financial incentive; follow-up; implementation science; in utero; innovation; member; neonate; neurobehavioral; opioid exposure; opioid use; opioid use disorder; opioid withdrawal; overtreatment; pain score; polysubstance use; prenatal; prescription opioid; programs; protocol development; psychologic; public health insurance; recruit; response; social; treatment effect

PROJECT SUMMARY/ABSTRACT The University of Arkansas for Medical Sciences (UAMS) will be a clinical site for the HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial-Clinical Sites (UG1), RFA-HD-21-031. Arkansas (AR) is a rural state with the second highest opioid prescription rate in the nation and is in the top 3 states nationwide for opioid prescriptions to pregnant mothers. Additionally, AR has the second highest number of Adverse Childhood Experiences in the nation, thus making this an ideal site to study the effects of opioid use in a state with other environmental stressors. Recruitment will be from a robust Women's Mental Health Program, which saw 899 pregnant women with opioid use disorder last year, the general obstetrical clinic, and the 64 bed academic Neonatal Intensive Care Unit (NICU) at UAMS. Innovative strategies for recruitment will include investigator attendance at prenatal classes and a Community Advisory Board, while retention will be bolstered by frequent electronic communication, updated contact information, financial and scheduling incentives. Follow-up will be performed at the Arkansas Children's Hospital Research Institute in a state of the art Pediatric Clinical Research Unit. Compliance for follow-up is anticipated to be challenging for this trial, so innovative strategies to encourage compliance will include monetary incentives, ease of scheduling, and case managers to arrange free travel, meals, and other needs for participants. Parents will also be given results of their psychological exams to encourage compliance. This project is well supported by the Translational Research Institute (TRI), home of a Clinical and Translational Science Award. This site has extensive experience conducting multicenter trials and is currently involved in two similar trials, which will be completed by the time this site will begin enrolling patients assuring this site will be ready to begin enrollment after funding. This site also has extensive experience in opioid research and will actively contribute to protocol development. Major strengths of this site include experience in pk/pd modeling, a robust telemedicine program to bolster awareness of the study statewide, and a Center for Implementation Science to implement evidence based weaning medication. This site has a large diverse clinical population with an average of 3450 annual deliveries, approximately 10% of the state's annual deliveries, with 273 opiate exposed neonates and 49 pharmacologically treated newborns annually. There are 53% white, 33% African American and 11% Hispanic mothers who deliver annually at UAMS. Public insurance accounts for 81% and private insurance accounts for 16% of all newborn admissions. This site has an excellent track record of participation in multicenter trials (12 trials are open currently) and a robust scholarly publication record. The assembled group of researchers at this site will contribute to the analysis, interpretation, and publication of results. The environment at this site is supportive of this initiative, and leadership will provide the support, protected time, and the infrastructure to successfully complete the study.

项目总结/摘要 阿肯色州医学科学大学（UAMS）将成为HEAL倡议的临床站点：新生儿 阿片类药物戒断综合征药物治疗效果比较试验-临床研究中心（UG1）， RFA-HD-21 - 031。阿肯色州（AR）是一个农村州，阿片类药物处方率在全国排名第二， 在全国范围内为孕妇开阿片类药物处方的前三个州。此外，AR还拥有第二个 全国不良童年经历数量最多，因此使其成为研究影响的理想场所。 阿片类药物的使用情况。招聘将从一个强大的妇女心理 健康计划，去年有899名孕妇患有阿片类药物使用障碍，普通产科诊所， 以及UAMS的64个床位的新生儿重症监护室（NICU）。创新的征聘战略将 包括调查员参加产前班和社区咨询委员会，而保留工作将 通过频繁的电子通信、更新的联系信息、财务和日程安排， 激励随访将在该州的阿肯色州儿童医院研究所进行 儿科临床研究中心。预计本试验的随访依从性具有挑战性，因此 鼓励遵守的创新战略将包括货币激励、简化调度和案例 经理为参加者安排免费旅行、用餐和其他需要。父母也会得到他们的成绩。 心理测试，以鼓励遵守。该项目得到了翻译研究的大力支持。 研究所（TRI），临床和转化科学奖的所在地。本网站拥有丰富的经验， 多中心试验，目前正在进行两项类似的试验，这两项试验将在本网站开始时完成 入组患者，确保该研究中心在获得资金后准备好开始入组。该网站也有广泛的 在阿片类药物研究方面具有丰富的经验，并将积极促进方案的制定。本网站的主要优势 包括PK/PD建模的经验，一个强大的远程医疗计划，以加强全州范围内的研究意识， 以及一个实施科学中心，以实施基于证据的断奶药物。这个网站有一个大的 多样化的临床人口，平均每年分娩3450人，约占该州年分娩量的10%。 每年有273名新生儿接触阿片类药物，49名新生儿接受阿片类药物治疗。有 53%的白色，33%的非洲裔美国人和11%的西班牙裔母亲每年在UAMS分娩。公共保险 在所有新生儿入院人数中，私人保险占81%，私人保险占16%。这个网站有一个很好的 参与多中心试验的跟踪记录（目前有12项试验开放）和可靠的学术出版物 记录该网站的研究人员将有助于分析，解释， 公布结果。该地点的环境支持这一倡议，领导层将提供 支持、保护时间和基础设施，以成功完成研究。