Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

Stress Clinical Trial

Official title:

Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697173
• Other study ID #: HM20019583
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: June 26, 2022

Study information

• Verified date: June 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: June 26, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Other:
• Single consent
A single consent form for possible procedures the child may undergo while in the PICU

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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)

Gill, M. PICU Prometheus: Ethical issues in the treatment of very sick children in Paediatric Intensive Care. Mortality, November 2005; 10(4): 262-275

Rodríguez-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. — View Citation

Society of Critical Care Medicine, Critical Care Statistics. Society of Critical Care Medicine, https://www.sccm.org/Communications/Critical-Care-Statistics. Retrieved 2020.

Outcome

Type	Measure	Description	Time frame	Safety issue
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 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	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.
Secondary	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.