Clinical trial NCT05220761: Family Assessment of Pediatric Delirium
Official title: FAM-CAPD: Family Assessment of Pediatric Delirium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital Research Institute
First posted: 2022-02-02
Enrollment: 235
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children admitted to 2 PICUs in Canada with an expected length of stay of \>/= 48 hours

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.

Eligibility criteria: Inclusion Criteria:

* Admitted to Alberta Children's Hospital or McMaster Children's Hospital PICU during study enrollment period
* Anticipated length of stay in PICU \>/=48 hours
* Substitute decision maker with the ability to provide informed consent
* Primary caregiver available for CAPD assessments,
* Primary caregiver is defined as the person primarily responsible for the care and upbringing of a child and could include: Parents, designated older sibling, foster parents/guardians, or grandparents, who fulfill this definition. There may be more than one primary caregiver for each child
* Translated CAPD and educational materials available in primary spoken language (French, Chinese, Italian or Spanish)

Exclusion Criteria:

I. Anticipated discharge/transfer within 24 hours II. Family member unable to understand the instructions for CAPD assessment

a. This will be identified by the research assistant in collaboration with the bedside care team. i.e. language/cognitive barrier III. Child in irreversible coma (i.e. persistent vegetative state, RASS -4/SBS -2 or less and not reversible)

Primary outcomes:
measure: Validity of delirium screening by caregivers
timeFrame: 1-28 days
Secondary outcomes:
measure: Healthcare professional acceptability of family administered delirium assessment
timeFrame: Up to 1 year
measure: Family/caregiver acceptability of family administered delirium assessment
timeFrame: Up to 1 year
measure: Correlation between absolute score of Richmond Agitation and sedation Scale and State Behavioral Scale.
timeFrame: 1-28 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Laurie A. Lee
state: Alberta
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: University of Calgary
name: Laurie A. Lee, MN
role: PRINCIPAL_INVESTIGATOR
References: