Clinical trial NCT04637113: Singapore's Health Outcomes After Critical Illness in Kids
Official title: Singapore's Health Outcomes After Critical Illness in Kids: the SHACK Study: A Longitudinal Mixed-methods Study in Singapore to Explore the Health Outcomes of Children and Their Parents in the First Six Months After PICU Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Critical Illness
Post Intensive Care Unit Syndrome
Keywords: critical illness
family
race
ethnicity
health outcomes
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Plymouth
First posted: 2020-11-19
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children age 1 month to 18 years old requiring PICU admission for ≥ 48 hours and their parents.

Brief summary: What is the problem? Every year about 2.5 million children are affected by critical illness and require admission to the pediatric intensive care unit (PICU). However, both children and their parents may encounter difficulties after critical illness. Children affected physically may have difficulties in breathing, eating, and drinking. Parents have reported feeling symptoms of stress such as nightmares and excessive worries after PICU discharge. Currently, the investigators do not know when and how the problems unfold and what harm does it cause. Without this information, healthcare professionals are not equipped to support these families after PICU discharge.

Research Plan? To understand how critical illness could affect the physical, emotional, and social experiences of children age 1 month to 18 years of age and their parents in the first 6 months after a PICU admission.

144 children and their parents will be followed from the time of PICU admission to 6 months after discharge. Children and their parents will complete surveys to measure physical, social, emotional and function outcomes. A total of 12 families will be interviewed at 1 and 3 months after PICU discharge. Using the data provided to map out any trend or changes in this information over time.

Why is this study important? To better understand the experience and health consequences of children and their parents in the first six months after PICU admission. This information would help to identify potential areas to improve the negative consequence of children and their families after a severe illness. Results will be shared to the PICU survivors and their families, national organizations, international pediatric intensive care community to improve the experiences and health outcomes following a PICU admission.


Eligibility criteria: Child inclusion criteria:

* Aged 1 month to 18 years at the point of PICU admission
* PICU total length of stay (LOS) ≥ 48 hours at the point of PICU discharge

Parents inclusion criteria:

* (a) Parent or legal guardian; (b) cohabits with the child
* For the family home to be the planned location following hospital discharge.

Exclusion Criteria:

* Opted for a "Do Not Resuscitate" status for their child and/or
* Had participated in the current study in a previous PICU admission within the recruitment period.

Primary outcomes:
measure: To describe and compare the change in total score of the Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) in children at baseline from 6 months after PICU discharge.
timeFrame: baseline and 6 months
Secondary outcomes:
measure: To determine the correlation between race/ethnicity, children's health baseline, and PICU factors with a total score of the Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) after PICU discharge.
timeFrame: 6 months
measure: To investigate the risk factors for parental PTSD using the PTSD Checklist for DSM-5 (PCL-5) six months after their child's' PICU discharge.
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital, Singapore
name: Pei-Fen Poh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manning JC, Pinto NP, Rennick JE, Colville G, Curley MAQ. Conceptualizing Post Intensive Care Syndrome in Children-The PICS-p Framework. Pediatr Crit Care Med. 2018 Apr;19(4):298-300. doi: 10.1097/PCC.0000000000001476.
citation: Abela KM, Wardell D, Rozmus C, LoBiondo-Wood G. Impact of Pediatric Critical Illness and Injury on Families: An Updated Systematic Review. J Pediatr Nurs. 2020 Mar-Apr;51:21-31. doi: 10.1016/j.pedn.2019.10.013. Epub 2019 Dec 23.
citation: Poh PF, Lee JH, Manning JC, Carey MC, Sultana R, Latour JM. Singapore's health outcomes after critical illness in kids: A study protocol exploring health outcomes of families 6 months after critical illness. J Adv Nurs. 2021 Aug;77(8):3531-3541. doi: 10.1111/jan.14911. Epub 2021 Jun 3.