The Effects of an Information-Based Discharge Preparation Service on the Outcomes of Preterm Infant, Parent, and Hospital: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 主要终点
- Readiness for Hospital Discharge Scale
研究概览
简要总结
Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied.
Objective:To evaluate the impact of IBDPS on parental readiness, caregiving skills, stress, satisfaction, infant development, readmission rates, length of stay, and hospital costs.
Design: A randomized controlled trial (RCT) in a NICU in Jiangsu Province, China.
Participants: Preterm infants and their parents.
Methods:Participants are randomly assigned to receive either IBDPS plus usual care (intervention group) or usual care alone (control group). Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge, along with hospital metrics like length of stay and readmission rates.
详细描述
Participants are randomly allocated to the intervention and control groups. The intervention group receives the IBDPS in addition to the usual care, while the control group receives only the usual discharge education. The IBDPS, grounded in the theories of empowerment and "Timing It Right (TIR)," leverages an information-based platform to provide continuous, multidimensional, and customized support to parents from their infants' admission to one month post-discharge, ensuring seamless integration of discharge preparation both online and offline, and within and outside the hospital. Baseline data are collected at allocation (T1). Parental outcomes, including readiness for hospital discharge and stress, are assessed at T1, upon NICU entry (T2), and prior to discharge (T3), while caregiving skills are measured at T1, T2, T3, and one month post-discharge (T4). Parental satisfaction is measured at T3. Infant outcomes, such as weight, length, head circumference, breastfeeding rate, and feeding intolerance rate, are recorded at T1, T2, T3, and T4, with Neonatal Behavior Neurologic Assessment (NBNA) scores evaluated at T4. Hospital outcomes include length of stay and hospitalization costs, assessed at T3, and unplanned readmissions, recorded at T4.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Infants:
- •Infants with a gestational age of less than 37 weeks at birth.
- •Written informed consent obtained from legal guardians.
- •Neonates delivered at the study hospital or transferred within the first 24 hours of life.
排除标准
- •for Infants:
- •Presence of major life-threatening congenital anomalies.
- •Critical illness or conditions requiring immediate intensive intervention.
- •Significant developmental abnormalities, including but not limited to severe congenital malformations, metabolic disorders, or central nervous system anomalies.
- •Removal Criteria for Infants:
- •Infants who experience abnormal discharge due to treatment abandonment, death, or transfer to another facility.
- •Inclusion Criteria for Parents:
- •Parents of infants born at less than 37 weeks of gestational age.
- •Written informed consent provided by the parents.
- •Ability to dedicate at least 4 hours per day to infant care.
- •Adequate reading comprehension and proficiency in using electronic devices.
- •If multiple caregivers are involved, the primary caregiver with the most hours of caregiving will be selected.
- •Exclusion Criteria for Parents:
- •Health, familial, social, or language barriers that impair effective integration into the healthcare team.
- •Removal Criteria for Parents:
- •Voluntary withdrawal from the study.
- •Non-compliance with study protocols.
研究组 & 干预措施
IBDPS intervention
Caregivers receive the IBDPS alongside usual care.
- Grounded in the theories of empowerment and "Timing It Right" (TIR), the IBDPS delivers continuous, individualized support through an information-based platform from admission to one month postdischarge, facilitating seamless integration of discharge preparation across both online and offline environments.
- Upon admission, caregivers register via WeChat, receiving tailored, stage-specific guidance on key topics such as "Growth," "Feeding," and "Sleep," aligned with the evolving needs of preterm infants. They can submit nursing concerns and assess their emotional state, with healthcare providers offering ongoing guidance. When the infant's condition stabilizes, caregivers can schedule NICU visits and engage in supervised bedside care training. Prior to discharge, hands-on training is provided. Postdischarge, caregivers upload growth data for continuous monitoring, with the option of home nurse visits.
干预措施: The information-based discharge preparation service (IBDPS) (Other)
Usual care
Receive the usual care.
- Routine admission education includes inpatient guidelines, breast milk storage, and receiving processes.
- During hospitalization, healthcare providers are responsible for all infant care. Caregivers can visit three times a week at scheduled times, with visiting days arranged by the odd or even numbers of the inpatient ID. Visits are conducted via live video, allowing caregivers to consult with doctors about the infant's condition.
- Upon discharge, healthcare providers educate caregivers on discharge precautions and preterm infant care methods.
- Follow-up is conducted through phone calls and outpatient visits.
结局指标
主要结局
Readiness for Hospital Discharge Scale
时间窗: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, and discharge,assessed up to 90 days.
The Readiness for Hospital Discharge Scale (RHDS) - Parent Form was originally developed by Weiss et al. for assessing the readiness of parents for the discharge of their hospitalized children (0 to 18 years old). The Chinese version of the Readiness for Hospital Discharge Scale (C-RHDS) - Parent Form, adapted by Chen et al. with authorization from the original authors, is utilized to evaluate the readiness of parents for the discharge of preterm infants. This 22-item scale includes four dimensions: Knowledge (9 items), Physical-emotional Status (7 items), Pain Status (2 items), and Expected Support (4 items). Each item is scored on a scale from 0 to 10 (0 = worst; 10 = best), with total scores ranging from 0 to 220. Higher scores reflect better readiness for discharge. The overall Cronbach α coefficient for this scale is 0.91.
次要结局
- Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants(From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.)