Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT05220761
Brief Summary:
In this study the investigators will assess the validity, reliability and acceptability of utilizing family members to complete a delirium screen using the Cornell Assessment of Pediatric Delirium (CAPD).
Detailed Description:
Diagnosing delirium in the heterogenous PICU population is difficult. There is significant variability in pre-morbid neurodevelopmental status in children due to both age-related development as well as pre-morbid cognitive delay. The Cornell Assessment of Pediatric Delirium (CAPD) has been validated in children of all ages and developmental stages. Several confounding factors have been identified that decrease the specificity of delirium detection and include confounding syndromes (i.e. iatrogenic withdrawal syndrome), pre-existing neuro-cognitive delay, and the specialty, experience and training of the assessor. Furthermore, pediatric critical care nurses have many competing interests in prioritizing care for their patients and can struggle with trying to familiarize themselves with the concept of delirium. This is a recognized barrier to routine compliance with delirium screening in PICUs. Family screening may be extremely valuable in early identification of delirium. This has been demonstrated in the critically ill adult population, however, with respect to family detection of delirium in their own children, the reliability of a pediatric screening tool has not been evaluated.
The proposed work is designed to improve both processes of care, by improving delirium screening, and patient outcomes by engaging families in the identification, prevention and management of delirium, in critically ill children.
This study will be conducted at 2 academic PICUs in Canada. Eligible children will be consented and enrolled. Parents/caregivers will be given brief education on delirium assessment and then complete a family tool based on the Cornell Assessment of Pediatric Delirium (CAPD). This will then be validated against the RN completed CAPD.
In order to also assess the acceptability of family detection of PICU delirium interviews of family members and focus groups of HCP will be conducted using qualitative methodology to determine acceptance and feasibility and to guide future knowledge translation work.
Study:
NCT05220761
Study Brief:
Protocol Section:
NCT05220761