Pilot-testing a Perinatal Palliative Care Intervention Program (PPC-pilot)

Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol

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 Overview

• Status: Recruiting
• Conditions: Perinatal Palliative Care; Life-limiting Fetal Diagnosis; Life-limiting Neonatal Diagnosis
• Intervention / Treatment: Behavioral: Perinatal palliative care

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laure Dombrecht; Phone Number: +32476046563; Email: laure.dombrecht@vub.be

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • UZ Brussels
    • Contact: Laure Dombrecht; Phone Number: 0476046563; Email: laure.dombrecht@vub.be
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • UZ Gent
    • Contact: Laure Dombrecht; Phone Number: 0476046563; Email: laure.dombrecht@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline group; Receives care as usual after severe perinatal diagnosis
Experimental: Perinatal palliative care group; Receives a new perinatal palliative care intervention after severe perinatal diagnosis	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 being offered to parents and healthcare providers, and 5. debriefings after every perinatal death are being organized in the involved team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	2 weeks after final contact moment or 6 months post inclusion
Parental Brief-COPE	Scoring of parental Brief-COPE (Coping Orientation to Problems Experienced Inventory) questionnaire. The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimize distress associated with negative life experiences. The scale can determine someone's primary coping styles with scores on the following three subscale: Problem-Focused Coping; Emotion-Focused Coping; and Avoidant Coping. Scores are presented for the three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style (higher scores = more engagement of that coping style).	2 weeks after final contact moment or 6 months post inclusion
Parental Satisfaction of Perinatal Palliative Care	Scoring of The Parental Satisfaction of Perinatal Palliative Care Instrument, which was developed to identify and measure parental satisfaction in perinatal palliative care for parents who opt to continue a pregnancy with a life-limiting fetal diagnosis. The instrument measures parent-reported care delivery addressing the pregnancy time continuum in three scales (Prenatal; Intrapartum; Postnatal). Items in the instrument are on a Likert scale from 1-7, with 1 indicating "strongly disagree," 4 indicating "does not apply/neutral," and 7 indicating "strongly agree." Higher scores reflect higher parental perception of quality care delivery. The Prenatal Scale includes 37 items (range from 37-259); the Intrapartum Scale includes 37 items (range from 37-259); and the Postnatal Scale includes 44 items (range from 44-308).	2 weeks after final contact moment or 6 months post inclusion
Healthcare provider Compassion Satisfaction and Fatigue questionnaire	Scoring of Healthcare provider Compassion Satisfaction and Fatigue questionnaire. ProQOL is a survey consisting of 30 items scaled on a five-point Likert scale, measuring three subscales consisting of 10 items each: Compassion Satisfaction, Burnout and Secondary Traumatic Stress. The Compassion satisfaction scale is about the pleasure derived from your work, with higher scores indicating that you derive a good deal of professional satisfaction from your position (range of 10-50). The burnout subscale is associated with feelings of hopelessness and difficulties in dealing with work or in doing your job effectively. Higher scores on this scale mean that you are at higher risk for burnout (range of 10-50). The secondary traumatic stress scale is about your work-related, secondary exposure to extremely or traumatically stressful events, with a higher score indicating a higher amount of experienced secondary traumatic stress (range of 10-50).	2 weeks after final contact moment or 6 months post inclusion
Healthcare provider Professional Satisfaction with Provided Care	Scoring of Healthcare provider Professional Satisfaction with Provided Care. This is a self-developed (not yet validated) questionnaire on Professional Satisfaction with Provided Care consisting of 48 items, based on the existing Parental Satisfaction of Perinatal Palliative Care Instrument used in the parental assessment, to assess whether healthcare providers are satisfied with the perinatal palliative care they and their team provided in a particular case, including satisfaction with communication among the team, and communication with parents. Psychometric properties of the scale need to be determined after the pilot test.	2 weeks after final contact moment or 6 months post inclusion
Healthcare provider experienced (psychological) support	Scoring of Healthcare provider experienced (psychological) support. This is a short, self-developed (not yet validated) questionnaire consisting of 6 items for physicians or 6 items for nurses, to assess the amound of (psychological) support that healthcare providers received during the care provision for this particular case. Psychometric properties of the scale need to be determined after the pilot test.	2 weeks after final contact moment or 6 months post inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental feasibility and acceptability of pilot	Parental feasibility and acceptability of pilot. As assessed by means of interviews.	2 weeks after final contact moment or 6 months post inclusion
Healthcare provider feasibility and acceptability of pilot	Healthcare provider feasibility and acceptability of pilot. As assessed by means of interviews.	2 weeks after final contact moment or 6 months post inclusion

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Investigators: Principal Investigator: Kristien Roelens, University Hospital, Ghent; Principal Investigator: Filip Cools, Brussels University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: PPC-pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No