Family Assessment of Pediatric Delirium

NCT ID: NCT05220761

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 235 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2024-06-30

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.

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

State Behavioral Scale; Richmond Agitation and Sedation Scale

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)

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Laurie Lee

Adjunct Clinical Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurie A. Lee, MN

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Laurie A. Lee

Calgary, Alberta, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

REB 20-2149

Identifier Type: -

Identifier Source: org_study_id