NCT04697173

Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

Completed NA Results posted Last updated 12 August 2024

What this trial tests

NA trial testing Single consent in Stress in 333 participants. Completed in 26 June 2022.

Timeline

13 January 2021

Primary endpoint
9 June 2022

26 June 2022

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	333
Start date	13 January 2021
Primary completion	9 June 2022
Estimated completion	26 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Single consent

Conditions studied

• Stress — all drugs for Stress →

Sponsor

Virginia Commonwealth University

Who can join

18 and older, any sex, with Stress. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU Primary · 48 - 72 hours after admission of child to PICU

Stress will be assessed using the Short Stress Overload Scale (SOS-S). The SOS-S is a 10 item questionnaire. Items are rated not at all (1) to a lot (5). Ratings are assigned a score and the scores are summed. Summed scores range from 10 - 50 with higher scores indicating greater stress. The SOS-S generates two subscores, Personal Vulnerability (PV) and Event Load (EL), with a score range from 5 to 25 for each. An individual's PV score corresponds to that individual's readiness to take on new stressors. Parents may be asked to complete the questionnaire multiple times depending on how long the

Group	Value	95% CI
Standard Consent	9	5 – 14
Bundled Consent	8	6 – 12

Number of Procedures Performed Without Appropriately Documented Consent Secondary · At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.

Number of procedures preformed without recorded consent will be determined by reviewing child's medical chart. Stress will be assessed using the Short Stress Overload Scale (SOS-S). The SOS-S is a 10 item questionnaire. Items are rated not at all (1) to a lot (5). Ratings are assigned a score and the scores are summed. Summed scores range from 10 - 50 with higher scores indicating greater stress. The SOS-S generates two subscores, Personal Vulnerability (PV) and Event Load (EL), with a score range from 5 to 25 for each. An individual's EL score quantifies the stress burden placed on that indiv

Group	Value	95% CI
Standard Consent	11	6 – 15
Bundled Consent	9	6 – 14

Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU Secondary · At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.

This was assessed by asking parent/caregiver a single question: "How life threatening do you believe your child's illness to be?" The question could be answered 1-5 with 1= not at all and 5= extremely.

Group	Value	95% CI
Standard Consent	3	2 – 5
Bundled Consent	3	2 – 4

Sponsor's own description

The purpose of this research study is to find out about how obtaining consent for procedures in the PICU affects parental/caregiver stress. The researchers think that alleviating some of the uncertainly of a PICU stay by discussing types of procedural support offered and obtaining informed consent prior to their immediate necessity may help decrease stress experienced by caregivers. This study will allow the researchers to learn more about it.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.