二级新生儿重症监护病房中的家庭综合护理（FICare）：一项整群随机对照试验的研究方案
Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.
作者信息
Benzies Karen M, Shah Vibhuti, Aziz Khalid, Isaranuwatchai Wanrudee, Palacio-Derflingher Luz, Scotland Jeanne, Larocque Jill, Mrklas Kelly, Suter Esther, Naugler Christopher, Stelfox Henry T, Chari Radha, Lodha Abhay
机构信息
Faculty of Nursing, Department of Paediatrics, University of Calgary, PF 2278, 2500 University Drive, NW, Calgary, AB, T2N 1N4, Canada.
Mount Sinai Hospital, Department of Paediatrics and Institute of Health Policy, Management and Evaluation, University of Toronto, Rm 19-231N, Mount Sinai Hospital, 600 University Avenue, Toronto, ON, M5G 1X5, Canada.
出版信息
Trials. 2017 Oct 10;18(1):467. doi: 10.1186/s13063-017-2181-3.
BACKGROUND
Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [32] to 33 weeks) and late preterm (34 to 36 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs.
METHODS
We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study.
DISCUSSION
Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.
背景
每年，全球约有1500万婴儿早产（妊娠37周前出生）。在艾伯塔省，2015年的早产率为8.7%，在加拿大各省中排名第二。约20%的早产儿在妊娠32周前出生（极早早产），需要在三级新生儿重症监护病房（NICU）接受治疗；80%的早产儿为中度早产（32周零天[32]至33周）和晚期早产（34至36周），需要在二级NICU接受治疗。早产以及在NICU的经历会破坏早期的亲子关系，并导致父母心理社会困扰。家庭综合护理（FICare）作为一种在三级NICU的护理模式显示出前景。本研究的目的是评估在二级NICU采用并实施FICare后的住院时间、母婴临床结局及成本。
方法
我们将在艾伯塔省的10个二级NICU进行一项实用的整群随机对照试验（cRCT），分为两组：FICare组或标准护理组。艾伯塔省的FICare模式包括三个基于理论的标准化组成部分：信息共享、育儿教育和家庭支持。我们每组181对母婴的样本量基于NICU住院时间的主要结局、80%的参与率以及随访时80%的保留率。次要结局（如婴儿临床结局和母亲心理社会困扰）将在入住NICU后不久、出院时以及矫正年龄2个月时进行评估。我们将从两个角度进行经济分析：公共医疗支付方和社会。为了解FICare的效用、可接受性和影响，将在2个月随访时对部分母亲进行定性访谈，并在研究接近尾声时对医院管理人员和医疗服务提供者进行访谈。
讨论
这项在艾伯塔省二级NICU进行的FICare实用cRCT的结果，将通过提供有关FICare临床有效性和成本的证据，为政策决策提供依据。
试验注册
ClinicalTrials.gov，标识符：NCT02879799。于2016年5月27日注册。方案版本：2016年6月9日；第2版。
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