Clinical trial NCT06456034: Pilot-testing a Perinatal Palliative Care Intervention Program
Official title: Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Palliative Care
Life-limiting Fetal Diagnosis
Life-limiting Neonatal Diagnosis
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.


Eligibility criteria: Inclusion Criteria:

* Parents:

  * who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or
  * who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child
* Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth

Additional inclusion criteria for parents:

* Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "Agentschap Integratie \& Inburgering"
* Parents are older than 18
* Parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child
* Parents are deemed (emotionally) approachable for the current study by the treating physician

For each family included in the pilot study, the physicians and nurses/midwives who will be/are most closely involved in the care of the infant and the parents will also be asked to participate. If healthcare providers refuse to provide informed consent to participate in the study, their data will be deemed as missing for that case (parental outcomes are considered as the primary outcome measures).

Primary outcomes:
measure: NeoComfort scale
timeFrame: every four hours (six times per day) during care provision for neonates only
measure: Administered medication and procedures
timeFrame: during care provision
measure: Contact moments with healthcare providers
timeFrame: during care provision
measure: Parental Perinatal Grief Scale
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
measure: Parental Brief-COPE
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
measure: Parental Satisfaction of Perinatal Palliative Care
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
measure: Healthcare provider Compassion Satisfaction and Fatigue questionnaire
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
measure: Healthcare provider Professional Satisfaction with Provided Care
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
measure: Healthcare provider experienced (psychological) support
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
Secondary outcomes:
measure: Parental feasibility and acceptability of pilot
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
measure: Healthcare provider feasibility and acceptability of pilot
timeFrame: 2 weeks after final contact moment or 6 months post inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Brussels University Hospital
name: Filip Cools
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Kristien Roelens
role: PRINCIPAL_INVESTIGATOR
References: