Trial Outcomes & Findings for Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit (NCT NCT04697173)

Last Updated: 2024-08-12

Results Overview

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 their child is in the PICU. This outcome measure only represents the PV portion of the SOS scale making the range from 5-25 (total of 5 questions each with a 1-5 scale).

Recruitment status

COMPLETED

Study phase

Target enrollment

333 participants

Primary outcome timeframe

48 - 72 hours after admission of child to PICU

Results posted on

2024-08-12

Participant Flow

This study only enrolled parents/caregivers of children admitted to the pediatric ICU and the protocol enrollment reflects the number of parent participants.

Participant milestones

Participant milestones
Measure	Standard Consent This group will be consented for invasive procedures using standard Hospital policy. Informed consent will be obtained either in person or via telephone with a witness from the patient or his/her legal guardian for any/all procedures medically indicated at that time, at the discretion of the Attending Physician.	Bundled Consent Upon admission, this group will received the document titled "Common PICU Procedures Explained" and encourage to read the document. They will then, within 12 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document. Single consent: A single consent form for possible procedures the child may undergo while in the PICU
Overall Study STARTED	166	167
Overall Study COMPLETED	132	129
Overall Study NOT COMPLETED	34	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Consent This group will be consented for invasive procedures using standard Hospital policy. Informed consent will be obtained either in person or via telephone with a witness from the patient or his/her legal guardian for any/all procedures medically indicated at that time, at the discretion of the Attending Physician.	Bundled Consent Upon admission, this group will received the document titled "Common PICU Procedures Explained" and encourage to read the document. They will then, within 12 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document. Single consent: A single consent form for possible procedures the child may undergo while in the PICU
Overall Study Withdrawal by Subject	34	38

Baseline Characteristics

Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Consent n=132 Participants This group will be consented for invasive procedures using standard Hospital policy. Informed consent will be obtained either in person or via telephone with a witness from the patient or his/her legal guardian for any/all procedures medically indicated at that time, at the discretion of the Attending Physician.	Bundled Consent n=129 Participants Upon admission, this group will received the document titled "Common PICU Procedures Explained" and encourage to read the document. They will then, within 12 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document. Single consent: A single consent form for possible procedures the child may undergo while in the PICU	Total n=261 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	132 Participants n=5 Participants	129 Participants n=7 Participants	261 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Female	64 Participants n=5 Participants	80 Participants n=7 Participants	144 Participants n=5 Participants
Sex/Gender, Customized Male	66 Participants n=5 Participants	48 Participants n=7 Participants	114 Participants n=5 Participants
Sex/Gender, Customized Did not identify	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	37 Participants n=5 Participants	43 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	132 participants n=5 Participants	129 participants n=7 Participants	261 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 - 72 hours after admission of child to PICU

Outcome measures

Outcome measures
Measure	Standard Consent n=132 Participants This group will be consented for invasive procedures using standard Hospital policy. Informed consent will be obtained either in person or via telephone with a witness from the patient or his/her legal guardian for any/all procedures medically indicated at that time, at the discretion of the Attending Physician.	Bundled Consent n=129 Participants Upon admission, this group will received the document titled "Common PICU Procedures Explained" and encourage to read the document. They will then, within 12 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document. Single consent: A single consent form for possible procedures the child may undergo while in the PICU
Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU	9 units on a scale Interval 5.0 to 14.0	8 units on a scale Interval 6.0 to 12.0

SECONDARY outcome

Timeframe: 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 individual by their current circumstances. Parents may be asked to complete the questionnaire multiple times depending on how long their child is in the PICU. This outcome measure only represents the EL portion of the SOS scale making the range from 5-25 (total of 5 questions each with a 1-5 scale).

Outcome measures

Outcome measures
Measure	Standard Consent n=132 Participants This group will be consented for invasive procedures using standard Hospital policy. Informed consent will be obtained either in person or via telephone with a witness from the patient or his/her legal guardian for any/all procedures medically indicated at that time, at the discretion of the Attending Physician.	Bundled Consent n=129 Participants Upon admission, this group will received the document titled "Common PICU Procedures Explained" and encourage to read the document. They will then, within 12 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document. Single consent: A single consent form for possible procedures the child may undergo while in the PICU
Number of Procedures Performed Without Appropriately Documented Consent	11 procedures Interval 6.0 to 15.0	9 procedures Interval 6.0 to 14.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Consent n=132 Participants This group will be consented for invasive procedures using standard Hospital policy. Informed consent will be obtained either in person or via telephone with a witness from the patient or his/her legal guardian for any/all procedures medically indicated at that time, at the discretion of the Attending Physician.	Bundled Consent n=129 Participants Upon admission, this group will received the document titled "Common PICU Procedures Explained" and encourage to read the document. They will then, within 12 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document. Single consent: A single consent form for possible procedures the child may undergo while in the PICU
Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU	3 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 2.0 to 4.0

Adverse Events

Standard Consent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Bundled Consent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nikki Miller Ferguson MD

Virginia Commonwealth University

Phone: 804-828-4080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place