虚拟家庭为中心的新生儿重症监护病房查房：一项群组随机对照试验的方案。
Virtual family-centered hospital rounds in the neonatal intensive care unit: protocol for a cluster randomized controlled trial.
机构信息
Department of Pediatrics, University of California Davis, 2516 Stockton Blvd, Sacramento, CA, 95817, USA.
Center for Health and Technology, University of California Davis, 4610 X Street, Sacramento, CA, 95817, USA.
出版信息
Trials. 2023 May 16;24(1):331. doi: 10.1186/s13063-023-07340-x.
BACKGROUND
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 hospital rounds is a promising solution. We aim to evaluate the impact of virtual family-centered hospital rounds in the neonatal intensive care unit on parental and neonatal outcomes.
METHODS
This two-arm cluster randomized controlled trial will randomize families of hospitalized infants to have the option to use telehealth for virtual hospital rounds (intervention) or usual care (control). The intervention-arm families will also have the option to participate in hospital rounds in-person or to not participate in hospital 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.
DISCUSSION
The findings from this trial will increase our understanding about virtual family-centered hospital 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.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05762835. Status: Not yet recruiting. First posted: March 10, 2023; last update posted: March 10, 2023.
背景
以家庭为中心的查房被认为是住院儿童的最佳实践，但只有当儿童的家属能够在住院期间在床边时，这种查房才可行。利用远程医疗将家庭成员虚拟地带到儿童床边进行查房是一种很有前途的解决方案。我们旨在评估新生儿重症监护病房中虚拟以家庭为中心的医院查房对父母和新生儿结局的影响。
方法
这是一项两臂聚类随机对照试验，将随机分配住院婴儿的家庭选择使用远程医疗进行虚拟医院查房（干预组）或常规护理（对照组）。干预组的家庭也可以选择亲自参加医院查房或不参加医院查房。在研究期间，所有符合条件的入住该单站点新生儿重症监护病房的婴儿都将被纳入。符合条件的要求是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果数据，以测试对以家庭为中心的查房参与度、父母体验、以家庭为中心的护理、父母激活、父母健康相关生活质量、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（可及性、有效性、采用、实施、维持）框架进行混合方法实施评估。
讨论
这项试验的结果将增加我们对新生儿重症监护病房中虚拟以家庭为中心的医院查房的理解。混合方法实施评估将增强我们对影响我们干预措施实施和严格评估的背景因素的理解。
试验注册
ClinicalTrials.gov 标识符：NCT05762835。状态：尚未招募。首次发布日期：2023 年 3 月 10 日；最后更新日期：2023 年 3 月 10 日。
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