Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit

NCT ID: NCT04697173

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2022-06-26

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.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 24 hours of admission be consented using the Bundle Consent Document for the group of invasive procedures listed and explained in that document.

Group Type: EXPERIMENTAL

Single consent

Intervention Type: OTHER

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

Interventions

Single consent

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikki Miller Ferguson, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 29477091 (View on PubMed)

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)

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 24372988 (View on PubMed)

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

Reference Type: 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.

Reference Type: DERIVED

PMID: 37125809 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HM20019583

Identifier Type: -

Identifier Source: org_study_id