Family Assessment of Pediatric Delirium

Delirium Clinical Trial

— FAM-CAPD  

Official title:

FAM-CAPD: Family Assessment of Pediatric Delirium

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05220761
• Other study ID #: REB 20-2149
• Status: Enrolling by invitation
• Start date: August 9, 2021
• Est. completion date: June 2024

Study information

• Verified date: October 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 235
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delirium

Intervention

Diagnostic Test:
• Cornell Assessment of Pediatric Delirium
Cornell Assessment of Pediatric Delirium is a diagnostic test for PICU delirium State Behavioral Scale and Richmond Agitation and Sedation Scale are diagnostic tests for sedation and agitation in children

Locations

Country	Name	City	State
Canada	Laurie A. Lee	Calgary	Alberta
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Children's Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of delirium screening by caregivers	Evaluate the validity of delirium screening by family or caregivers using the cornel assessment of pediatric delirium on their own children while they are admitted to a PICU	1-28 days
Secondary	Healthcare professional acceptability of family administered delirium assessment	Explore health care professionals perception and acceptability of family administered delirium assessment in critically ill children	Up to 1 year
Secondary	Family/caregiver acceptability of family administered delirium assessment	Explore family member/caregiver perception and acceptability of family administered delirium assessment in critically ill children	Up to 1 year
Secondary	Correlation between absolute score of Richmond Agitation and sedation Scale and State Behavioral Scale.	To assess the correlation between the absolute score of the Richmond Agitation and Sedation Scale [-5(unarousable) to +4(Combative)] and the State Behavioral Scale [-3 (unresponsive) to +2(agitated)] for each child in assessing sedation and agitation in critically ill children	1-28 days