Pilot-testing a Perinatal Palliative Care Intervention Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perinatal palliative care.
- Who it may be relevant to
- Registry conditions: Perinatal Palliative Care, Life-limiting Fetal Diagnosis, Life-limiting Neonatal Diagnosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol
Overview
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.
Interventions
- Behavioral Perinatal palliative care
Intervention group will receive specialized perinatal palliative care support from moment of severe perinatal diagnosis. This intervention is aimed at 5 major care components, namely 1. Support offered by a fixed perinatal palliative care team, 2. that team has received specialized perinatal palliative care training, 3. care is structured within a new perinatal palliative care approach or pathway, including fixed means of communication with team members, 4. psychological support is structurally
Primary outcome measures
- NeoComfort scale [Time frame: every four hours (six times per day) during care provision for neonates only]
- Administered medication and procedures [Time frame: during care provision]
- Contact moments with healthcare providers [Time frame: during care provision]
- Parental Perinatal Grief Scale [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
- Parental Brief-COPE [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
- Parental Satisfaction of Perinatal Palliative Care [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
- Healthcare provider Compassion Satisfaction and Fatigue questionnaire [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
- Healthcare provider Professional Satisfaction with Provided Care [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
- Healthcare provider experienced (psychological) support [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
Secondary outcome measures (2)
- Parental feasibility and acceptability of pilot [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
- Healthcare provider feasibility and acceptability of pilot [Time frame: 2 weeks after final contact moment or 6 months post inclusion]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Belgium · 2 centers
- UZ Brussels — Brussels
- UZ Gent — Ghent
Identifiers
NCT: NCT06456034 · PPC-pilot