Stress
Conditions
Brief summary
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
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.
Interventions
OTHERSingle consent
A single consent form for possible procedures the child may undergo while in the PICU
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU | 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Procedures Performed Without Appropriately Documented Consent | 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). |
| Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU | 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. |
Countries
United States
Participant flow
Pre-assignment details
This study only enrolled parents/caregivers of children admitted to the pediatric ICU and the protocol enrollment reflects the number of parent participants.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 132 |
| 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 | 129 |
| Total | 261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 34 | 38 |
Baseline characteristics
| Characteristic | Standard Consent | Bundled Consent | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 132 Participants | 129 Participants | 261 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 43 Participants | 80 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) White | 75 Participants | 75 Participants | 150 Participants |
| Region of Enrollment United States | 132 participants | 129 participants | 261 participants |
| Sex/Gender, Customized Did not identify | 2 Participants | 1 Participants | 3 Participants |
| Sex/Gender, Customized Female | 64 Participants | 80 Participants | 144 Participants |
| Sex/Gender, Customized Male | 66 Participants | 48 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 132 | 3 / 129 |
| other Total, other adverse events | 0 / 132 | 0 / 129 |
| serious Total, serious adverse events | 0 / 132 | 0 / 129 |
Outcome results
Primary
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 (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).
Time frame: 48 - 72 hours after admission of child to PICU
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Consent | Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU | 9 units on a scale |
| Bundled Consent | Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU | 8 units on a scale |
Secondary
Number of Procedures Performed Without Appropriately Documented Consent
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).
Time frame: At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Consent | Number of Procedures Performed Without Appropriately Documented Consent | 11 procedures |
| Bundled Consent | Number of Procedures Performed Without Appropriately Documented Consent | 9 procedures |
Secondary
Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU
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.
Time frame: At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Consent | Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU | 3 units on a scale |
| Bundled Consent | Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU | 3 units on a scale |