Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- Parent FCR Attendance
研究概览
简要总结
The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolling family units (which consists of INFANTS and PARENTS [SURVEYS]):
- •INFANT Inclusion
- •Infants aged less than 365 days who are admitted to the NICU
- •Have at least one adult parent or guardian with English proficiency
- •INFANT Exclusion
- •Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information
- •Infants with a previous NICU admission (and enrollment) during the trial period
- •PARENTS [SURVEYS] Inclusion
- •Parents/guardians of the eligible infants (described above)
- •Age 18 years and older
- •PARENTS [SURVEYS] Exclusion
- •Age less than 18 years
- •Non-English speaking
排除标准
- 未提供
研究组 & 干预措施
Intervention (Virtual Family-Centered Rounds [FCR])
Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR.
干预措施: Virtual family-centered rounds (FCR) (Behavioral)
Control (Usual Care)
Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.
结局指标
主要结局
Parent FCR Attendance
时间窗: Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
Obtained from FCR weekday observations. Defined at family unit level, accounting for possibility of multiple enrolled infants per family and variable eligible FCR encounters for each infant. We will compute the total number of possible weekday FCR encounters per family ('denominator') and the number of those for which at least 1 parent is present virtually or in-person ('numerator'). The outcome measure will be reported as a proportion (numerator/denominator). For example, if a family has 2 infants, 1 whose NICU hospitalization included 5 eligible FCR encounters and another whose NICU hospitalization includes 7 eligible FCR encounters, that family will be counted as having twelve eligible FCR encounters ('denominator'). If at least 1 parent is present for 4 of the first infant's encounters and 6 of the second infant's encounters, the family would be counted as having attended 10 ('numerator') of the 12 eligible FCR encounters. The proportion for that family unit is 0.83.
次要结局
- Parent Activation(Day 0 (post-NICU discharge))
- Parent Activation(Day 0 (post-NICU discharge))
- NICU Length of Stay(Day 0 (post-NICU discharge))
- Parent Experience(Day 0 (post-NICU discharge))
- Family-Centered Care(Day 0 (post-NICU discharge))
- Parent Health-related Quality of Life(Day 0/30/60/90 (post-NICU discharge))
- Breastmilk Feeding(Day 0/90 (post-NICU discharge))
- Postnatal Growth Failure (Dichotomous)(Day 0 (post-NICU discharge))
- Postnatal Growth Failure (Categorical)(Day 0 (post-NICU discharge))