Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
Phase: NA
Conditions: Stress
Sponsor: Virginia Commonwealth University

 
 
Title: The Effects of Expectation Setting and Bundle Consent on Caregiver Stress in the Pediatric ICU 
 
NCT #: NCT04697173 
 
Document date: December 1, 2020 
 
Document Type: Protocol and SAP 
 
 
 

 
 
 
 
The Effects of Expectation Setting and Bundle 
Consent on Caregiver Stress in the Pediatric 
ICU 
Gregory Goldstein, MD, Oliver Karam, MD, PhD, Nikki Miller Ferguson, MD 
 
Protocol synopsis  
Study identifier 
Bundle Consent and Caregiver Stress 
 
Type of study 
Prospective Cluster Randomized Control Trial 
  
Background 
 
Having a child admitted to the Pediatric Intensive Care Unit 
(PICU) is a challenging and stressful experience for parents 
and caregivers. Despite the high survival when compared to 
adult ICUs1, a PICU admission can have meaningful long term 
negative health consequences for adult caregivers including 
symptoms of depression, anxiety and PTSD2.  
 
There is little known in regards to what specific factors impact 
the mental health of 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.3 This uncertainly is palpable in the PICU for many 
reasons.  
 
First, few caregivers are medically savvy enough to appreciate 
the diversity and scope of pathology that is routinely treated in 
the PICU. They may not know that PICU is an acronym for 
Pediatric Intensive Care Unit or that the sickest children in the 
hospital are cared for in that unit.4 They may have no 
experience with pediatric illness beyond a simple viral process. 
Therein lies a major source of stress and uncertainty and basis 
of a question intensivists often field, “Have you ever seen a 
child this sick?” 
  
Intensivists can and often do attempt to mitigate this 
uncertainty with illness specific anticipatory guidance. 
However, providing that guidance, and often re-assurance, in 
the PICU can be challenging due to the uncertain trajectory of 
pediatric illness. It is frequently difficult to counsel caregivers 
on what to expect during their hospitalization without becoming 
too hypothetical or presenting conflicting possible scenarios.5 
 
Prior research suggests that invasive procedures can be a 
significant source of immediate stress for caregivers. This 
uncertainty is compounded by the fact that it is common 
practice to introduce the idea of invasive procedures, and 
subsequently obtain consent, only when that procedures is 
likely to be required. This leads to obtaining informed consent, 
a concept with legal significance, in the setting of a 
deteriorating child and subsequently a caregiver under 
significant duress. 

 
 
 
 
 
This forces us to consider the question, are we obtaining 
morally and legally valid informed consent or, despite our best 
efforts, are we obtaining coerced consent? 
  
To further illustrate the possibility of coerced consent, one can 
consider how often parents or guardians refuse to give consent 
for invasive procedures? In general practice, and the 
experience of the PICU in which I currently practice, caregiver 
refusal is a very rare occurrence. This my because in pediatric 
critical care practice there are few good alternatives to the 
types of invasive procedures that we commonly perform 
(intubation, 
central 
venous 
catheterization, 
arterial 
catheterization, and procedural sedation). However, it maybe 
be because intensivists are, unintentionally, overwhelming 
caregivers who are in acutely stressful and emotionally 
vulnerable states.  
  
The complex landscape of the PICU described above presents 
a unique opportunity to simultaneously obtain consent under 
less stressful circumstances and set realistic expectations as 
to the nature of a PICU admission, a means of alleviating some 
of the uncertainly of a PICU stay by introducing the types of 
procedural support we can offer and obtaining informed 
consent prior to their immediate necessity. In this study we will 
use a prospective cluster randomized design to compare 
caregiver stress level via the Short Stress Overload Scale 
(SOS-S) in a control arm our current model of obtaining ad-hoc 
for invasive procedures. In the experimental arm, employing a 
scripted bundle consent upon admission to the PICU, which will 
serve the dual purpose of consenting parents and/or legal 
guardians for 5 commonly performed invasive procedures as 
well as general expectation setting for the PICU) 
 
Hypothesis 
Caregivers that are consented for invasive procedures via a 
bundle consent at the time of admission to the PICU will report 
less stress at 48-72 hours post admission and at the time of 
discharge than those consented via the current ad-hoc model 
of consent. 
  
Study objectives 
1. To quantify caregiver stress and determine if a bundle 
consent and expectation setting can decrease that stress. 
 
2. To determine the change in  the proportion of procedures 
performed without appropriate and documented written 
consent, between the current ad-hoc model of consent and 
a bundle consent process. 
 
 
Study population 
Parents or caregivers of patients admitted to a PICU during the 
designated study period 
 
 
 

 
 
 
 
Main inclusion criteria 
Parents or caregivers of critically ill children admitted to the 
Pediatric ICU during the designated study period.   
 
Main exclusion criteria 
Anticipated length of PICU stay < 24 hours,  
Non-English speaking patients  
 
Study intervention 
Scripted consent for the following invasive procedures (central 
venous catheter, arterial catheter, intubation, procedural 
sedation) by a PICU Attending, Fellow, or Nurse Practitioner 
within 12 hours of admission to the Pediatric ICU. 
 
Data collection  
Patient and caregiver demographic, as well as patient 
diagnostic, therapeutic and procedural data will be collected as 
well as caregiver self-reported stress scores via the Short 
Stress Overload Scale (SOS-S) 
 
 
Clinical endpoints 
Discharge from the Pediatric ICU or if interim analysis dictates 
that harm is being done as discussed under Ethical 
Considerations heading.  
 
 
Confounding variables 
• 
Patient demographic data (age) 
• 
Patient PELOD-2 Score  
• 
Type of admission (planned, direct from ED, transfer from 
floor, transfer from outside Hospital) 
• 
Prior NICU or PICU stay admission 
• 
Caregiver 
demographic 
data 
(Age, 
Sex, 
Ethnic 
background, highest education level) 
• 
Caregiver assessment of “Life-threatening” nature of illness 
using a Likert scale 
 
Ethical considerations 
As this study evaluates consent, and particularly the possibility 
of coerced consent, it is not possible to create a design that 
involved consent for participation that does not jeopardize the 
integrity of the study. Furthermore, our experimental 
intervention, a bundled consent process, is currently being 
utilized at various pediatric and adult ICUs in the United States 
and will meet all of the legal requirements for informed consent 
in the state of Virginia. We will therefore ask for a waiver of 
individual informed consent for randomization. We will be 
asking for caretaker consent for the collection of demographic 
data and measurement of caretaker stress.    
 
The scripted bundle consent process will add no risk of physical 
harm to the Pediatric ICU patient. We recognize the possibility 
that our intervention may result in an increase in stress and/or 
anxiety to parents and/or caregivers in the experimental group 
and therefore plan to conduct interim analyses (after the first 
50 and 100 patients) to ensure that no harm is being done, with 
the intent of terminating our study if we show an increase in 
caregiver stress of 20% or more in the experimental group.  
 
Furthermore, for the study participants in both groups, we plan 
to use caregiver stress scores as a basis for referral to already 
existing internal mechanism for caregiver stress mitigation, 

 
 
 
 
including but not limited to: Social Work, Case Management 
and Child Life services if a caregiver’s score fall in the “High 
Stress” quadrant (High Personal Vulnerability and High Event 
Load Scale)  
 
 
Methodology 
Control and Experimental groups will be created using a cluster 
randomization design in alternating periods beginning of the 1st 
and 15th of each month.  
 
Caregivers included in the control group will be admitted to the 
PICU and undergo consent for invasive procedures as is 
indicated by the clinical needs of their children as per current 
unit practices. 
 
Caregivers included in the experimental group will, within 12 
hours of admission, be consented for: central venous catheter, 
arterial catheter, intubation, and procedural sedation via a 
scripted bundled consent by an PICU Attending, Fellow, or 
Nurse Practitioner.  
 
Then, for both groups, at 48-72 hours after admission and at 
the time of discharge from the PICU, they will receive and 
complete the SOS-S, either electronically or on paper, to 
measure stress, which will then be collected and recorded.  
 
Any caregiver in the experimental or control group identified to 
fall into the “High Stress” group as per the SOS-S will be 
referred 
to 
pre-existed 
support 
services 
within 
the 
PICU/VCUHS infrastructure.  
 
All data recorded will be completely de-identified and collected 
within REDCap. 
 
 
 
Statistical plan 
First, we will identify the confounding factors using a bivariate 
regression model between each of the following factors and the 
primary outcome: patient age, type of admission, prior ICU 
admissions, caregiver demographic data, and caregiver 
assessment of life-threatening illness. 
 
Second, the association between the bundle consent process 
and the outcome (caregiver stress) will be investigated using 
logistic regression models, adjusting for the confounding 
factors identified in step one. 
 
Third, a multivariable logistic regression will be performed with 
all variables (full model). The simplification of this full model will 
be done using another multivariable logistic regression with 
backward selection at the level p = 0.05.  
 
 
Sample size 
After examining prior studies which used the SOS-S to quantify 
pathologic stress reactions, We estimate a mean SOS-S score 
of 19.9 and a standard deviation of 11.3. We anticipate a 20% 
reduction in SOS-S score in the experimental group (i.e. from 

 
 
 
 
19.9 to 15.9). Setting an alpha of 0.05 and power of 0.8. We 
anticipate requiring a sample size of 266 caregivers to 
sufficiently test the null hypothesis.  
 
 
Location 
Pediatric Intensive Care Unit at the Children’s Hospital of 
Richmond, VCUHS 
 
 
Study duration 
We admit an average of 1000 patients per year, 83 patients per 
month. We anticipate at participation rate of 80%. Therefore we 
anticipate a study duration of 4 month to enroll the necessary 
number of patients.  
 
Anticipated results 
A scripted consent bundle signed at the time of admission will 
lead to decrease in measured caregiver stress at 48-72 hours 
of PICU stay and at the time of discharge from the ICU.  
 
Future perspectives 
This will be the another step in create a Pediatric ICU 
environment that will be able to minimize the emotional and 
psychologic stress on the parents and caregivers Pediatric ICU 
patients.  
 
 
References 
1. Society of Critical Care Medicine, Critical Care 
Statistics. 
Society 
of 
Critical 
Care 
Medicine, 
https://www.sccm.org/Communications/Critical-Care-
Statistics. Retrieved 2020.  
2. Rodrı´guez-Rey R, Alonso-Tapia J, Colville G. 
Prediction of parental posttraumatic stress, anxiety and 
depression after a child’s critical hospitalization. J Crit 
Care. 2018;45:149-155.  
3. Durette, M. (2013). Uncertainty and Primary Appraisal 
as Predictors of Acute Stress Uncertainty and Primary 
Appraisal as Predictors of Acute Stress Disorder in 
Parents of Critically Ill Children: A Mediational Model. 
(Doctoral Thesis)  
4. Butler, A., Copnell B., Willetts, G., Family Centered care 
in the paediatric intensive care unit: an integrative 
review of the literature. Journal of Clinical Nursing, 
2013. 23, 2086-2100: 10.1111/jocn.12498. 
 
5. Gill, M. PICU Prometheus: Ethical issues in the 
treatment of very sick children in Paediatric Intensive 
Care. Mortality, November 2005; 10(4): 262-275