NCT04168515

Brief Summary

The investigators aim to conduct a qualitative study evaluating the long and short-term recollection and experiences of critically ill children with delirium as well as collect the lived experience of the caregiver and healthcare provider involved in the patient's care. The investigators objective is to determine if there are common themes to these experiences, and if these themes are associated with specific pediatric delirium subtypes (hypoactive, hyperactive, and mixed). The overall goal is to better understand the impact of delirium on patients and their caregivers, and develop strategies to improve education, prevention and management when caring for children with pediatric intensive care unit(PICU)-acquired delirium.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

September 3, 2019

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participant lived experience of delirium based on qualitative, semi-structured interviews

    Participants will be asked open-ended questions about their delirium experience. The interviews will be transcribed and "coded" for themes by the investigators. These codes will be input into qualitative software (NVIVO) and analyzed iteratively for each interview. As this is a qualitative study, there are no expected outcomes. Outcomes will be determined by the themes that arise from the delirium interview process.

    12 months

Study Arms (3)

Patient

Caregiver

Healthcare provider

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Critically ill children aged under 18 years, who are diagnosed with delirium during their PICU admission, and/or their caregivers and health care providers, will be approached for consent to participate in qualitative interviews.

You may qualify if:

  • Pediatric ICU patients admitted in the last year
  • less than 18 years old
  • delirium during PICU admission (CAPD score equal to/greater than 9 x 48 hours)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4K1, Canada

RECRUITING

Related Publications (6)

  • Zetterlund P, Plos K, Bergbom I, Ringdal M. Memories from intensive care unit persist for several years--a longitudinal prospective multi-centre study. Intensive Crit Care Nurs. 2012 Jun;28(3):159-67. doi: 10.1016/j.iccn.2011.11.010.

    PMID: 22579396BACKGROUND
  • Samuelson KA. Unpleasant and pleasant memories of intensive care in adult mechanically ventilated patients--findings from 250 interviews. Intensive Crit Care Nurs. 2011 Apr;27(2):76-84. doi: 10.1016/j.iccn.2011.01.003. Epub 2011 Mar 2.

    PMID: 21371888BACKGROUND
  • Traube C, Silver G, Reeder RW, Doyle H, Hegel E, Wolfe HA, Schneller C, Chung MG, Dervan LA, DiGennaro JL, Buttram SD, Kudchadkar SR, Madden K, Hartman ME, deAlmeida ML, Walson K, Ista E, Baarslag MA, Salonia R, Beca J, Long D, Kawai Y, Cheifetz IM, Gelvez J, Truemper EJ, Smith RL, Peters ME, O'Meara AM, Murphy S, Bokhary A, Greenwald BM, Bell MJ. Delirium in Critically Ill Children: An International Point Prevalence Study. Crit Care Med. 2017 Apr;45(4):584-590. doi: 10.1097/CCM.0000000000002250.

    PMID: 28079605BACKGROUND
  • Svenningsen H, Egerod I, Dreyer P. Strange and scary memories of the intensive care unit: a qualitative, longitudinal study inspired by Ricoeur's interpretation theory. J Clin Nurs. 2016 Oct;25(19-20):2807-15. doi: 10.1111/jocn.13318. Epub 2016 Jul 26.

    PMID: 27457029BACKGROUND
  • Zhang Z, Pan L, Ni H. Impact of delirium on clinical outcome in critically ill patients: a meta-analysis. Gen Hosp Psychiatry. 2013 Mar-Apr;35(2):105-11. doi: 10.1016/j.genhosppsych.2012.11.003. Epub 2012 Dec 4.

    PMID: 23218845BACKGROUND
  • Flaigle MC, Ascenzi J, Kudchadkar SR. Identifying Barriers to Delirium Screening and Prevention in the Pediatric ICU: Evaluation of PICU Staff Knowledge. J Pediatr Nurs. 2016 Jan-Feb;31(1):81-4. doi: 10.1016/j.pedn.2015.07.009. Epub 2015 Sep 9.

    PMID: 26362671BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Karen Choong, MB, BCh, MSc

CONTACT

Jasmin Moradi, MD, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

November 19, 2019

Study Start

September 10, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations