Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

Conditions
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Stress

Intervention / Treatment
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* Other: Single consent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard consent<br>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. | |
| Experimental: Bundled consent<br>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. | Other: Single consent<br>* A single consent form for possible procedures the child may undergo while in the PICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent/Caregiver Stress 48 to 72 hours following admission to the Pediatric ICU | 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 to a lot. Ratings are assigned a score and the scores are summed. Summed scores range from 10 - 50 with higher scores indicating greater stress. Parents may be asked to complete the questionnaire multiple times depending on how long their child is in the PICU. | 48 - 72 hours after admission of child to PICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of procedures performed without appropriately documented consent | Number of procedures preformed without recorded consent will be determined by reviewing child's medical chart | At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first. | 
| Parent/Caregiver Stress at time of Discharge from the Pediatric ICU | Stress will be assessed using the Short Stress Overload Scale (SOS-S) | At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first. |