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…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Adjustment disorders (incl subtypes)
- Family issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is parental stress at discharge, as defined by the total score
on the Parental Stress Scale (PSS:NICU). The PSS: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*).
Secondary outcome
Secondary outcome measures on the individual level will be parent participation
in neonatal care, parent-infant bonding and experiences 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, neonatal
secondary outcome measures will be taken into account, specifically length of
stay, breastfeeding rates at discharge, biomarkers of stress in saliva,
methylation rate of glucocorticoid receptors (from buccal mucosa) and growth.
On the cluster level we will study professional secondary outcome measures such
as work engagement and autonomy.
Background summary
Parents are often appointed a passive role during the admission of their
preterm (born before 37 weeks of gestational age) or ill infant. 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
physician and nurse without presence and participation of the parents. Parents
are usually updated by the nurse afterwards. Family Centred Rounds (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 to ask questions and participate in shared decision
making. Family Integrated Care (FICare) comprises a framework to implement FCR
by bringing parents, medical and nursing staff together and involving parents
as equal partners, minimizing separation, and supporting parent-infant
closeness. FICare consists of a collaborative program of psychological,
educational, communication, and environmental 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.
Study objective
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 neonatal ward for >7 days as compared to standard daily
rounds (SDR) without parents with SNC. We primarily hypothesize that FCR and
FICare are superior to SNC with regard to parental stress at discharge.
Secondary outcomes in parents include participation in neonatal care,
experience in shared decision making, parent-infant bonding, biomarkers of
stress (in hair and saliva), breastmilk composition and the longitudinal course
of parent mental health after infant discharge. Infant outcomes include
breastfeeding at discharge, growth, biomarkers of stress in saliva and length
of hospital stay. For healthcare professionals outcomes such as work engagement
and autonomy will be analysed at the cluster level. Cost-effectiveness analysis
will be done as well at the level of parents 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 the Netherlands will
participate. Timing of start of intervention will be randomised between sites.
Intervention
The intervention will consist of parental participation in medical rounds
(FCR). Parents and healthcare professionals will be supported by the four
pillars of FICare: parent education, education of healthcare professionals,
psychosocial support and environment of the neonatal ward.
Study burden and risks
Due to the nature of this study and the risk of cross-contamination,
randomization on the individual level is not possible. It concerns hospitalized
neonates that are treated with FICare or SNC for at least 1 week and are
followed until the (corrected) age of 12 months. They are minor and thereby
incapacitated subjects. The risk for SAEs is negligible. Regarding the CCMO
guidelines in minors the risk must be negligible and the objections must be
minimal.
The burden of participation for parents is low and consists of (digital or
physical) participation in medical rounds, participating in care, filling out
questionnaires at different time points and the collection of hair-, saliva-
and breastmilk samples. Hence, the burden is mainly time-related and is
non-invasive. The total amount of time required to fill out the questionnaires
will be approximately 20-30 minutes every time.
The burden for the infants is none, since all studied parameters are part of
the routine clinical care and are noted in the clinical chart and the
collection of saliva and buccal mucosa is non-invasive. Moreover, the infants
cared for according to the FICare with involvement of parents could have better
breastfeeding and growth rates. Parents could experience less stress, and
healthcare professionals could feel more engaged and autonomous at work.
Concluding, the risks are negligible, the burden is minimal and this study
might show equal or better outcomes in infants treated with FICare. This
implicates that the research question is group-related and can only be
performed in this group of infants.
Oosterpark 9
AC 1091
NL
Oosterpark 9
AC 1091
NL
Listed location countries
Age
Inclusion criteria
- infant requiring hospital admission directly (within 24 hours) after birth
- parents of 18 years or older
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL78176.100.21 |