Parental Participation on the Neonatal Ward - the neoPARTNER Study
- Conditions
- Infant, Premature, DiseasesPerinatal ProblemsInfant, Small for Gestational AgeSmall for Gestational Age InfantMaternal DistressPrematureNeonatal HyperbilirubinemiaInfant DevelopmentInfant, Newborn, DiseaseParent-Child Relations
- Interventions
- Other: Family Integrated Care
- Registration Number
- NCT05343403
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
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).
- Detailed Description
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.
Primary study parameters/outcome of the study: The main outcome is parental stress at discharge, as defined by the total score on the Parental Stress Scale (PSS:NICU). ThePSS:NICU is a three-dimensional tool, in which parents express the amount of stress they experienced by rating 26 items on a 5-point Likert scale ("not stressful at all" to "extremely stressful").
Secundary study parameters/outcome of the study (if applicable): Secondary outcome measures on the individual level will be parent participation in neonatal care, parent-infant bonding andexperiences in shared decision making. The longitudinal course of parental mental health (anxiety, depression, posttraumatic stress)will be analyzed, as well as biomarkers of stress (in saliva, hair and breastmilk) and breastmilk composition. Also, neonatalsecondary outcome measures will be taken into account, specifically length of stay, breastfeeding rates at discharge, biomarkers ofstress in saliva and growth. On the cluster level we will study professional secondary outcome measures such as work engagementand autonomy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 613
- Infant requiring hospital admission directly (within 24 hours) after birth;
- Parent of 18 years or older;
- Written informed consent of both parents.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Family Integrated Care Family Integrated Care During the intervention period, Family Integrated Care (FICare) will be implemented on the neonatal wards of the participating hospitals. Families that are included during this intervention period will participate in Family Centred Rounds (FCR), while being supported by the principles of FICare. FICare incorporates psychological, educational, communication, and environmental strategies to support parents and to prepare them emotionally, cognitively, and physically to care autonomously for their infant at the time of discharge. In FCR, parents actively participate in the medical rounds and decisions are made based on shared-decision making. Not only are parents informed about the clinical condition of their child, they can ask questions and share their own valuable information on their child. Such information can include the overall wellbeing but also specific medical information.
- Primary Outcome Measures
Name Time Method Level of parental stress 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.
- Secondary Outcome Measures
Name Time Method Experiences of Shared Decision Making Immediately after intervention (at discharge of the infant) Patient Reported Outcome: Shared Decision Making Questionnaire (SDM-Q-9, Kriston et al. 2010). Range: original score of 0-45 points calculated into score with range of 0-100 points, higher score indicating higher levels of shared decision making.
Infant development At the corrected age of 12 months. Patient Reported Outcome: Ages and Stages Questionnaire, edition 3 (Flamant et al, 2011). Range: 0-300 points, higher score indicating better infant development.
Length of hospital stay (infant) During intervention (estimated average of 21 days). Duration of the hospital admission of the infant, expressed in days.
Parent-infant attachment Immediately after intervention (at discharge of the infant) Maternal (or Paternal) Postnatal Attachment Scale (Condon et al., 1998). Range: 19-95 points, lower score indicating problematic mother-to-infant bonding or father-to-infant bonding, respectively.
Cost-effectiveness (healthcare professionals) Through study completion, an average of 21 months. Work absence as registered at the hospital administration, and self-reported outcome: Productivity Cost Questionnaire (Bouwmans et al., 2015). No range applicable.
Level of parental participation in neonatal care Immediately after intervention (at discharge of the infant) Patient Reported Outcome: CO-PARTNER tool (van Veenendaal et al, 2021). Range: 0-62, higher score indicating higher level of participation.
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 Patient Reported Outcome: PROMIS Anxiety, Shortform (PROMIS Health Organisation). Range: 8-40 points (calculated into a T-score with a mean of 50 and a standard deviation of 10), higher score indicating more symptoms of anxiety.
Symptoms of parental depression Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months Patient Reported Outcome: PROMIS Depression, Shortform (PROMIS Health Organisation). Range: 8-40 points (calculated into a T-score with a mean of 50 and a standard deviation of 10), higher score indicating more symptoms of depression.
Change in experience of Shared decision making (healthcare professionals) Through study completion, an average of 21 months. Self-reported outcome: Shared Decision Making Questionnaire-Physician Version. (Rodenburg-Vandenbussche et al., 2015). Range: original score of 0-45 points calculated into score with range of 0-100 points, higher score indicating higher levels of shared decision making.
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 Patient Reported Outcome: Post-traumatic Stress Disorder Checklist for DSM-5 (Weathers et al., 2013). Range: 0-80, higher score indicating more symptoms of posttraumatic stress.
Cost-effectiveness on parent and infant level At the corrected age of 12 months. Patient Reported Outcome: Productivity Cost Questionnaire \& Medical Consumption Questionnaire (Bouwmans et al, 2015 \& 2013, respectively). No scale applicable.
Amount of breastfeeding Immediately after intervention (at discharge of the infant). Amount of breastfeeding defined as percentage of total (enteral) intake
Infant growth Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months Rate of weight gain during hospital stay and during first year of life.
Change in experienced work engagement (healthcare professionals) Through study completion, an average of 21 months. Self-reported outcome: Utrechtse Work Engagement Scale (Schaufeli et al., 2003). Range: 0-6 points, higher score indicating higher levels of work engagement.
Change in experienced work autonomy (healthcare professionals) Through study completion, an average of 21 months. Self-reported outcome: Job Content Questionnaire, Decision Authority Subscale (Karasek et al., 1998). Range: 3-12 points, higher score indicating more feeling of autonomy.
Family Centred Rounds Through study completion, an average of 21 months. % of medical rounds with parental presence as reported by healthcare professionals
Trial Locations
- Locations (10)
Amphia Ziekenhuis
🇳🇱Breda, Brabant, Netherlands
Flevoziekenhuis
🇳🇱Almere, Flevoland, Netherlands
Zaans Medisch Centrum
🇳🇱Zaandam, Noord Holland, Netherlands
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Noord Holland, Netherlands
BovenIJ Ziekenhuis
🇳🇱Amsterdam, Noord Holland, Netherlands
Franciscus Gasthuis & Vlietland
🇳🇱Rotterdam, Zuid Holland, Netherlands
Ziekenhuis Amstelland
🇳🇱Amstelveen, Noord Holland, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Overijssel, Netherlands
Tergooi Medisch Centrum
🇳🇱Blaricum, Noord Holland, Netherlands
Juliana Kinderziekenhuis
🇳🇱Den Haag, Zuid Holland, Netherlands