Pilot-testing a Perinatal Palliative Care Intervention Program

Vrije Universiteit Brussel20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Perinatal Palliative Care Life-limiting Fetal Diagnosis Life-limiting Neonatal Diagnosis

Interventions

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 being offered to parents and healthcare providers, and 5. debriefings after every perinatal death are being organized in the involved team.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (2)

UZ Brussels

Brussels, Belgium

RECRUITING

UZ Gent

Ghent, Belgium

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

NeoComfort scale

The validated NeoComfort scale will be used to assess pain and discomfort. The COMFORTneo scale is composed of 7 behavioral dimensions: As respiratory response applies to ventilated neonates only, and crying to spontaneously breathing neonates only (including those requiring continuous positive airway pressure), the rater will actually rate 6 dimensions. Alertness, calmness/agitation, facial tension, muscle tone, body movement are rated for all neonates. As responses are on a 1 to 5 Likert scale, total scores range from 6 to 30-with higher scores indicating more pain.scores range from 6 to 30-with higher scores indicating more pain.

Time frame: every four hours (six times per day) during care provision for neonates only

Administered medication and procedures

All medication administration and procedures followed are registered throughout the care trajectory. Duration or timing is impossible to predict.

Time frame: during care provision

Contact moments with healthcare providers

Contact moments between healthcare providers and parents are registered throughout the care trajectory. Duration or timing is impossible to predict.

Time frame: during care provision

Parental Perinatal Grief Scale

Scoring of the parental Perinatal Grief Scale. The short version of the Perinatal Grief Scale consists of 33 items that represents three subscales each consisting of 11 items: active grief (sadness, missing the baby, crying for the baby), difficulty coping (difficulty in dealing with normal activities with other people, withdrawal and depression), and despair (feelings of worthlessness and hopelessness). Each item is scored on a 5-point likert scale, resulting in a possible range of 33-165. Higher scores reflect more intense grief.