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: 10891305
• 负责人: RICHARD Whittington HALL
• 金额: $ 22.8万
• 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 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10891305
• 关键词: HEAL; Initiative; Neonatal; Opioid; Withdrawal

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.

项目摘要/摘要 阿肯色州医科大学(UAMS)将成为Hear Initiative的临床地点：新生儿 阿片戒断综合征药理治疗疗效比较试验-临床试验(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， 是全国给怀孕母亲开阿片类药物处方最多的三个州。此外，AR还拥有第二个 全国最多的不良童年经历，因此这里是研究这些影响的理想地点 在有其他环境压力的情况下使用阿片类药物的可能性。招聘将来自健康的女性心理 健康计划，去年有899名患有阿片类药物使用障碍的孕妇，普通产科诊所， 和UAMS的病床新生儿重症监护病房。创新的招聘战略将 包括调查员参加产前班和社区咨询委员会，而留用人员将 得到频繁的电子通信、更新的联系信息、财务和日程安排的支持 激励措施。后续将在阿肯色州儿童医院研究所进行 ART儿科临床研究部。在这次试验中，后续行动的合规性预计将面临挑战，因此 鼓励合规的创新战略将包括金钱激励、简化日程安排和案例 经理为参与者安排免费的旅行、餐饮和其他需求。家长也将获得他们的成绩 通过心理测试来鼓励合规。该项目得到了翻译研究中心的大力支持 临床与翻译科学奖获得者所在的研究所。该网站有丰富的经验进行 多中心试验，目前正在参与两个类似的试验，将在本网站开始时完成 招募患者，确保这个网站将准备好在获得资金后开始注册。这个网站也有广泛的 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建模经验，一个强大的远程医疗计划，以提高全州对这项研究的认识， 和一个实施科学中心，实施基于证据的断奶药物治疗。这个网站有一个很大的 多样化的临床人群，平均每年接生3450人，约占该州年接生人数的10% 每年有273名接触鸦片类药物的新生儿和49名接受药物治疗的新生儿分娩。确实有 53%的白人，33%的非裔美国人和11%的西班牙裔母亲每年在UAMS分娩。公共保险 占81%，私人保险占所有新生儿入院人数的16%。这个网站有一个很好的 参与多中心试验的跟踪记录(目前正在进行12项试验)和强大的学术出版物 唱片。在这个地点聚集的研究人员小组将为分析、解释和 结果的公布。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。