Rosenthal Jennifer L, Tancredi Daniel J, Marcin James P, Ketchersid Audriana, Horath Elva T, Zerda Erika N, Bushong Trevor R, Merriott Daniel S, Romano Patrick S, Young Heather M, Hoffman Kristin R
Department of Pediatrics, University of California Davis, 2516 Stockton Blvd, Sacramento, CA 95817.
Center for Health and Technology, University of California Davis, 4610 X Street, Sacramento, CA 95817.
Res Sq. 2023 Apr 17:rs.3.rs-2644794. doi: 10.21203/rs.3.rs-2644794/v1.
Family-centered rounds is recognized as a best practice for hospitalized children, but it has only been possible for children whose families can physically be at the bedside during hospital rounds. The use of telehealth to bring a family member virtually to the child’s bedside during rounds is a promising solution. We aim to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes. This two-arm cluster randomized controlled trial will randomize families of hospitalized infants to have the option to use telehealth for virtual rounds (intervention) or usual care (control). The intervention-arm families will also have the option to participate in rounds in-person or to not participate in rounds. All eligible infants who are admitted to this single-site neonatal intensive care unit during the study period will be included. Eligibility requires that there be an English-proficient adult parent or guardian. We will measure participant-level outcome data to test the impact on family-centered rounds attendance, parent experience, family-centered care, parent activation, parent health-related quality of life, length of stay, breastmilk feeding, and neonatal growth. Additionally, we will conduct a mixed methods implementation evaluation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The findings from this trial will increase our understanding about virtual family-centered rounds in the neonatal intensive care unit. The mixed methods implementation evaluation will enhance our understanding about the contextual factors that influence the implementation and rigorous evaluation of our intervention. ClinicalTrials.gov Identifier: NCT05762835. Status: Not yet recruiting. First Posted: 3/10/2023; Last Update Posted: 3/10/2023.
以家庭为中心的查房被认为是住院儿童的最佳实践,但对于那些在医院查房期间家人无法亲自到床边陪伴的儿童来说,此前一直无法实现。利用远程医疗在查房期间让家庭成员虚拟地出现在孩子床边是一个很有前景的解决方案。我们旨在评估新生儿重症监护病房中虚拟的以家庭为中心的查房对父母和新生儿结局的影响。这项双臂整群随机对照试验将把住院婴儿的家庭随机分为两组,一组可以选择使用远程医疗进行虚拟查房(干预组),另一组接受常规护理(对照组)。干预组的家庭还可以选择亲自参加查房或不参加查房。研究期间入住该单中心新生儿重症监护病房的所有符合条件的婴儿都将被纳入。入选条件要求有一位英语熟练的成年父母或监护人。我们将测量参与者层面的结局数据,以测试对以家庭为中心的查房参与率、父母体验、以家庭为中心的护理、父母参与度、父母与健康相关的生活质量、住院时间、母乳喂养和新生儿生长的影响。此外,我们将使用RE-AIM(覆盖范围、有效性、采用率、实施情况、维持情况)框架进行混合方法实施评估。该试验的结果将增进我们对新生儿重症监护病房中虚拟的以家庭为中心的查房的理解。混合方法实施评估将增强我们对影响干预措施实施和严格评估的背景因素的理解。ClinicalTrials.gov标识符:NCT05762835。状态:尚未招募。首次发布日期:2023年3月10日;最后更新发布日期:2023年3月10日。