Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

NCT04697173 | Completed Results

• 1 other identifier: HM20019583
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• 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).

  48 - 72 hours after admission of child to PICU

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Standard consent

NO INTERVENTION

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.

Bundled consent

EXPERIMENTAL

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

Interventions

Single consent OTHER

A single consent form for possible procedures the child may undergo while in the PICU

Bundled consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents/caregivers (\>18 years) of children admitted to the Pediatric ICU during the designated study period

You may not qualify if:

• Anticipated length of PICU stay \< 24 hours
• Non-English speaking parents/caregivers

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (6)

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

  BACKGROUND

• 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.

  PMID: 29477091 BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 24372988 BACKGROUND

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

  BACKGROUND

• Goldstein G, Karam O, Miller Ferguson N. The Effects of Expectation Setting and Bundle Consent on Acute Caregiver Stress in the PICU: A Randomized Controlled Trial. Pediatr Crit Care Med. 2023 Aug 1;24(8):692-700. doi: 10.1097/PCC.0000000000003265. Epub 2023 May 1.

  PMID: 37125809 DERIVED

MeSH Terms

Interventions

Consent Forms

Intervention Hierarchy (Ancestors)

Informed Consent; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Records; Organization and Administration; Health Services Administration; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Nikki Miller Ferguson MD
• Organization: Virginia Commonwealth University

nikki.millerferguson@vcuhealth.org

804-828-4080

Study Officials

• Nikki Miller Ferguson, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: January 13, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 26, 2022
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)