Collaborating to Improve Neonatal Care: ParentAl paRticipation on The NEonatal waRd - the neoPARTNER Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 613
- 试验地点
- 10
- 主要终点
- Level of parental stress
研究概览
简要总结
Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for >7 days as compared to standard medical rounds (SMR) without parents as part of standard neonatal care (SNC).
详细描述
Parents are often appointed a passive role during the admission of their preterm (born before 37 weeks of gestational age) or illinfant. Multiple studies have demonstrated that information and communication are crucial for families of intensive care patients.However, common practice in neonatal wards regarding daily rounds is that the medical rounds are only attended by the physicianand nurse without presence and participation of the parents. Parents are usually updated by the nurse afterwards. Family CentredRounds (FCR) include parents on daily rounds (digital or physical presence), involving them in the process of patient management,allowing them to hear their infants' conditions first-hand, to provide information on their child's general wellbeing themselves and toask questions and participate in shared decision making. Family Integrated Care (FICare) comprises a framework to implement FCRby bringing parents, medical and nursing staff together and involving parents as equal partners, minimizing separation, andsupporting parent-infant closeness. FICare consists of a collaborative program of psychological, educational, communication, andenvironmental strategies to support parents to cope with neonatatal environment and to prepare them to be able to emotionally,cognitively, and physically care for their infant.
Objective of the study: To investigate the effect of FCR during hospital stay, accompanied by FICare, on parental stress at discharge in parents of preterm(born before 37 weeks of gestational age) or ill (for instance with sepsis or small for gestational age) infants admitted to the neonatalward for >7 days as compared to standard daily rounds (SDR) without parents with SNC. We primarily hypothesize that FCR andFICare are superior to SNC with regard to parental stress at discharge. Secondary outcomes in parents include participation inneonatal care, experience in shared decision making, parent-infant bonding, biomarkers of stress (in hair and saliva), breastmilkcomposition and the longitudinal course of parent mental health after infant discharge. Infant outcomes include breastfeeding atdischarge, growth, biomarkers of stress in saliva and length of hospital stay. For healthcare professionals outcomes such as workengagement and autonomy will be analysed at the cluster level. Cost-effectiveness analysis will be done as well at the level ofparents and healthcare professionals.
Study design: A multicentre stepped wedge cluster randomised trial will be conducted. A total of 10 hospitals with a level 2 neonatal ward in theNetherlands will participate. Timing of start of intervention will be randomised between sites.
Study population: All (parents of) infants admitted to the neonatal ward directly after birth, or transferred to a participating centre after birth in aneonatal intensive care unit (NICU) are eligible for participation in the study.
Intervention (if applicable): The intervention will consist of parental participation in medical rounds (FCR). Parents and healthcare professionals will besupported by the four pillars of FICare: parent education, education of healthcare professionals, psychosocial support andenvironment of the neonatal ward.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant requiring hospital admission directly (within 24 hours) after birth;
- •Parent of 18 years or older;
- •Written informed consent of both parents.
排除标准
- •Infant's hospital stay shorter than 7 days;
- •Infant with severe congenital or syndromal anomaly;
- •Infant with critical illness who is unlikely to survive;
- •Parent with current psychosocial problems (such as posttraumatic stress disorder, schizophrenia or psychotic disorders) with or without medication which have not been stable over the past year;
- •Involvement of child protective services in the family;
- •Parent not able or not willing to fill out questionnaires in English or Dutch.
结局指标
主要结局
Level of parental stress
时间窗: Immediately after intervention (at discharge of the infant)
Patient Reported Outcome: Parental Stress Scale: Neonatal Intensive Care Unit (Miles, 1993). Range: 0-135 points, higher score indicating higher levels of parental stress.
次要结局
- Experiences of Shared Decision Making(Immediately after intervention (at discharge of the infant))
- Infant development(At the corrected age of 12 months.)
- Length of hospital stay (infant)(During intervention (estimated average of 21 days).)
- Parent-infant attachment(Immediately after intervention (at discharge of the infant))
- Cost-effectiveness (healthcare professionals)(Through study completion, an average of 21 months.)
- Level of parental participation in neonatal care(Immediately after intervention (at discharge of the infant))
- Symptoms of parental anxiety(Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months, 3, 6 and 12 months corrected age)
- Symptoms of parental depression(Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months)
- Change in experience of Shared decision making (healthcare professionals)(Through study completion, an average of 21 months.)
- Symptoms of parental posttraumatic stress(Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months)
- Cost-effectiveness on parent and infant level(At the corrected age of 12 months.)
- Amount of breastfeeding(Immediately after intervention (at discharge of the infant).)
- Infant growth(Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months)
- Change in experienced work engagement (healthcare professionals)(Through study completion, an average of 21 months.)
- Change in experienced work autonomy (healthcare professionals)(Through study completion, an average of 21 months.)
- Family Centred Rounds(Through study completion, an average of 21 months.)
研究者
Dr. Sophie van der Schoor
Principal Investigator
Onze Lieve Vrouwe Gasthuis