跳至主要内容
临床试验/NCT05220761
NCT05220761Enrolling By Invitation不适用

FAM-CAPD: Family Assessment of Pediatric Delirium

University of Calgary2 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2021年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
235
试验地点
2
主要终点
Validity of delirium screening by caregivers

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

结局指标

主要结局

Validity of delirium screening by caregivers

时间窗: 1-28 days

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurie Lee

Adjunct Clinical Associate

University of Calgary

研究点 (2)

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