N/A
N=104
Decision Making Support for Parents and Caregivers
Neonatal Critical Illness · Pediatric Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT05733975 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Enrollment Rate (Critically Ill Infants) — 24; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Making Guide (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate (Critically Ill Infants) |
24; 30 | — |
| PRIMARY Complete Data Collection (Critically Ill Infants) |
29; 1 | — |
| SECONDARY Parent and Clinician Acceptability |
30; 28; 10; 2; 35; 29 | — |
| SECONDARY Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) |
53.8; 51.8; 57.7; 57.5; 47.8; 52.5 | — |
| SECONDARY Parent Preparation for Decision Making, as Measured by the PrepDM |
73.75 | — |
Summary
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
Eligibility Criteria
Study participants will include English-speaking parents of critically ill infants and children admitted to Duke University Hospital.
Infant inclusion criteria will include
- age < 1 year,
- admission to a critical care unit, and
- an anticipated serious health care decision
All parents of eligible infants will be considered for inclusion. Parent exclusion criteria will include 1) age < 18 years, 2) hearing or speech impairment, and 3) non-English speakers.
All clinicians of eligible infants will be considered for inclusion.
Data sourced from ClinicalTrials.gov (NCT05733975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.