Family Assessment of Pediatric Delirium

NCT05220761 | Unknown

• 1 other identifier: REB 20-2149
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 2

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).

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Healthcare professional acceptability of family administered delirium assessment

  Up to 1 year

• Family/caregiver acceptability of family administered delirium assessment

  Up to 1 year

• Correlation between absolute score of Richmond Agitation and sedation Scale and State Behavioral Scale.

  1-28 days

Interventions

Cornell Assessment of Pediatric Delirium DIAGNOSTIC_TEST

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

Also known as: State Behavioral Scale, Richmond Agitation and Sedation Scale

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Children's Hospital Research Institute: collaborator

Study Sites (2)

Laurie A. Lee

Calgary, Alberta, T2T 5T3, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Laurie A. Lee, MN

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Clinical Associate

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: February 2, 2022
• Study Start: August 9, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)