Clinical trial NCT04697173: Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
Official title: Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU
timeFrame: 48 - 72 hours after admission of child to PICU
Secondary outcomes:
measure: Number of Procedures Performed Without Appropriately Documented Consent
timeFrame: At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.
measure: Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU
timeFrame: At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Nikki Miller Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Society of Critical Care Medicine, Critical Care Statistics. Society of Critical Care Medicine, https://www.sccm.org/Communications/Critical-Care-Statistics. Retrieved 2020.
citation: Rodriguez-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 Jun;45:149-155. doi: 10.1016/j.jcrc.2018.02.006. Epub 2018 Feb 16.
citation: 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)
citation: Butler A, Copnell B, Willetts G. Family-centred care in the paediatric intensive care unit: an integrative review of the literature. J Clin Nurs. 2014 Aug;23(15-16):2086-99. doi: 10.1111/jocn.12498. Epub 2013 Dec 26.
citation: Gill, M. PICU Prometheus: Ethical issues in the treatment of very sick children in Paediatric Intensive Care. Mortality, November 2005; 10(4): 262-275