Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Stress

Treatments: Other: Single consent

Study type: Interventional

Funder types: Other

Identifiers

NCT04697173

HM20019583

Details and patient eligibility

About

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.

Full description

Having a child admitted to the Pediatric Intensive Care Unit (PICU) is a deeply challenging and stressful experience for parents and caregivers. Despite the high survival when compared to adult ICUs, a PICU admission can have meaningful long-term, negative health consequences for adult caregivers including symptoms of depression, anxiety and PTSD. There is little known in regards to what specific factors impact the mental health of parents/caregivers of PICU patients. However, research into stress and anxiety has suggested that uncertainty is a significant contributor to stress when faced with a new environment.

Usual informed consent for procedures performed in the PICU is obtained immediately prior to the procedure. Participants will be randomly assigned (like the flip of a coin) to either usual informed consent prior to each procedure or to a single consent form obtained upon admission to PICU for possible procedures their child may undergo. In this study participants will be asked to complete a survey at two separate times during the child's PICU hospitalization- 48-72 hours after admission and again upon transfer or discharge from the PICU. Data will be collected about the child from the medical record including age, diagnosis/reason for PICU admission, length of stay, and any procedures performed in PICU requiring consent.

Enrollment: 333 patients

Sex: All

Ages: 18 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parents/caregivers (>18 years) of children admitted to the Pediatric ICU during the designated study period

Exclusion criteria

• Anticipated length of PICU stay < 24 hours
• Non-English speaking parents/caregivers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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333 participants in 2 patient groups

Standard consent

No Intervention group

Description:

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

Experimental group

Description:

Upon admission, this group will received the document titled "Common PICU Procedures Explained" and encourage to read the document. They will then, within 24 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document.

Treatment:

Other: Single consent