Family Assessment of Pediatric Delirium (FAM-CAPD)

FAM-CAPD: Family Assessment of Pediatric Delirium

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Delirium
• Intervention / Treatment: Diagnostic test: Cornell Assessment of Pediatric Delirium

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 Type: Observational
• Enrollment (Anticipated): 235

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5T3
      • Laurie A. Lee
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children admitted to 2 PICUs in Canada with an expected length of stay of >/= 48 hours

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Children's Hospital Research Institute
• Investigators: Principal Investigator: Laurie A. Lee, MN, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: REB 20-2149

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