PICU Journal for Critical Illness

(PICUJournal Trial)

Overseen By Christelle Scott, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Prior PICU experience, English proficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if keeping a journal during a child's stay in the pediatric intensive care unit (PICU) reduces stress and improves emotional health for both parents and children. The journal allows parents to express their feelings and concerns, potentially aiding in coping during this difficult time. Parents with a child hospitalized in the PICU at Monroe Carell Jr. Children's Hospital at Vanderbilt, who have not previously experienced a PICU admission, are well-suited for this trial. The study also examines how journaling affects the child's stress and development after hospital discharge. As an unphased trial, this study provides a unique opportunity to enhance understanding of how journaling can support families during challenging hospital stays.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the PICU Journal intervention is safe for parents and children?

Research shows that a "PICU Journal" is practical and appreciated by families in the pediatric intensive care unit (PICU). Previous studies have not identified any major negative effects from this activity. Instead, it helps parents and caregivers manage stress and improve communication while their child is in the PICU.

Although limited research exists specifically on the safety of the PICU Journal, it is merely a journaling activity. It does not involve medical procedures or medications, reducing the risk of physical harm. The goal is to support emotional well-being, making it much safer compared to medical treatments.

In summary, the PICU Journal is considered safe for parents and caregivers in the PICU. It provides a supportive way to manage the stress and uncertainty of having a child in intensive care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PICU Journal intervention because it offers a new way to support families during a child's critical illness. Unlike standard medical treatments that focus solely on the physical health of patients, this journal aims to improve emotional well-being by engaging parents and caregivers in the care process. By documenting experiences and observations, the journal helps families process their emotions and stay informed, potentially reducing stress and anxiety. This holistic approach could enhance the overall care experience for both families and healthcare providers, making it a promising addition to pediatric intensive care.

What evidence suggests that the PICU Journal is effective for reducing stress and improving outcomes for parents and children in the PICU?

This trial will evaluate the use of a "PICU Journal" for parents and caregivers of children in the pediatric intensive care unit (PICU). Research has shown that using such a journal can be helpful. Early findings suggest that journaling reduces stress and anxiety by providing families a safe space to express feelings and communicate with healthcare staff. Previous studies have demonstrated that this practice can improve emotional health and might lower the risk of post-traumatic stress for both parents and children after hospital discharge. Families have responded positively to journaling, finding it practical and supportive during their child's hospital stay. While more data is still being gathered, the positive feedback and early benefits are encouraging. ^{4 6 7 8 9}

Who Is on the Research Team?

Kristina Betters, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for primary caregivers of children aged 1 month to 21 years admitted to the PICU at Monroe Carell Jr. Children's Hospital, who are new to the PICU experience and can read and write English. Their child should be in the hospital for 24-72 hours and able to participate in early mobility activities.

Inclusion Criteria

My child qualifies for Level 1 or 2 of the Early Mobility Protocol.

I am the main caregiver for a child in intensive care at Monroe Carell Jr. Children's Hospital.

The participant is proficient in reading and writing the English language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Parents/caregivers participate in the PICU journal intervention during their child's PICU stay

Duration of child's PICU stay

Continuous engagement during PICU stay

Peri-discharge

Data collection including stress, anxiety, and depression scales, and journal satisfaction survey

Within 48 hours of child's discharge

Follow-up

Participants are monitored for stress, anxiety, depression, and impact of events post-discharge

3 months post-discharge

1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PICU Journal

Trial Overview The study tests if a 'PICU Journal' helps reduce stress, anxiety, depression, and prevents post-intensive care syndrome (PICS) in both parents/caregivers and their hospitalized children by serving as an outlet for expressing experiences.

How Is the Trial Designed?

Group I: Parents/Caregivers Experimental Treatment 1 Intervention

Parents/caregivers of children hospitalized in the PICU at Monroe Carell Jr. Children's Hospital at Vanderbilt who will participate in the PICU journal intervention

Group II: Patients Active Control 1 Intervention

Pediatric patients ages 8 to 18 years whose parents/caregivers participated in the PICU journal intervention

Group III: PICU providers and staff Active Control 1 Intervention

PICU providers and staff who observed or participated in the PICU journal intervention during its use with parents/caregivers

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Published Research Related to This Trial

In a study of 740 patients in a pediatric intensive care unit (PICU), systematic enquiry identified 80% of adverse events, including serious ones, while voluntary reporting mainly captured insignificant and minor events, highlighting the limitations of each method.

A total of 524 adverse events were recorded, with systematic enquiry detecting 405 events and voluntary reporting only capturing 166, indicating that relying solely on voluntary reporting may miss critical incidents in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit. Silas, R., Tibballs, J.[2010]

In a South African pediatric intensive care unit (PICU), a retrospective audit identified a high rate of adverse events (50.8 per 100 patient days) among 80 patients, with catheter complications and hypoglycemia being the most common issues.

The study found that real-time registration during ward rounds reported a lower rate of adverse events (27.2 per 100 patient days) among 236 patients, highlighting that different registration methods can yield varying insights into patient safety and types of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. Vermeulen, JM., van Dijk, M., van der Starre, C., et al.[2014]

In a study of 734 pediatric patients discharged from 15 U.S. PICUs, 62% experienced at least one adverse event (AE), with a notable rate of 28.6 AEs and 4.9 adverse drug events (ADEs) per 100 patient-days, highlighting the high incidence of safety issues in this critical care setting.

The research identified that surgical patients, those who were intubated, and patients who died had significantly higher rates of AEs and ADEs, indicating specific population characteristics that increase risk and emphasizing the need for targeted prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events in pediatric intensive care units in the United States. Agarwal, S., Classen, D., Larsen, G., et al.[2022]

Children who survive the pediatric intensive care unit (PICU) are at risk of developing post-intensive care syndrome in pediatrics (PICS-p), which can lead to new physical, cognitive, emotional, and social health issues.

Implementing best practices in the PICU can help reduce the risk of PICS-p by minimizing iatrogenic injuries and supporting the resilience of both the children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Critical Care Outcomes: State of the Science. Perry-Eaddy, MA., Dervan, LA., Manning, JC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8578758/

Transitions from short to long-term outcomes in pediatric ... The aim of this review is to present the potential considerations of implementing long-term clinical follow-up following pediatric critical illness.

2. withpower.com withpower.com/trial/phase-critical-illness-10-2023-5ef41

PICU Journal for Critical Illness · Info for Participants What data supports the effectiveness of the treatment PICU Journal for Critical Illness? The development of a structured outcomes assessment and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8639621/

Overall Health following pediatric critical illness: a scoping ... Among the 407 articles which measured outcomes following pediatric critical illness, 161 (40%) measured overall health. The overall health domain was most ...

4. publications.aap.org publications.aap.org/pediatrics/article/154/1/e2024066285/197569/Improving-PICU-Family-Outcomes-Moving-From

Improving PICU Family Outcomes: Moving From ... The outcomes of interest, measured at least 3 months post-PICU discharge, include quality of life and psychological diagnoses.

5. journals.lww.com journals.lww.com/pccmjournal/fulltext/2024/11001/pp241_topic__as24_resuscitation,_stabilization__.228.aspx

Pediatric Critical Care Medicine This study compares severity-of-illness, frequency of critical interventions within 1 hour and 12 hours of PICU admission, and PICU length of stay (LOS)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368216/

Sustainability of a PICU Situation Awareness Intervention This is a single-center qualitative study at a tertiary care pediatric center examining the sustainability of an interprofessional situation awareness bundle.

7. journals.lww.com journals.lww.com/pccmjournal/fulltext/2024/11001/pp505_topic__as22_quality_and_safety_errors_data.433.aspx

PP505 Topic: AS22–Quality and Safety/Errors/Data... Conclusions: This study demonstrates the crucial role of such structured approach in PICU in enhancing patient safety and minimizing the occurrence of UE.

8. publications.aap.org publications.aap.org/pediatrics/article/149/4/e2021053432/185684/Mobilization-Safety-of-Critically-Ill-Children

Mobilization Safety of Critically Ill Children | Pediatrics Early PICU mobilization has a strong safety profile and medical equipment dislodgement is rare. No PICU interventions were associated with increased potential ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000298

A photo-narrative intervention protocol for clinicians and ... This study will evaluate the feasibility and acceptability of a novel photo-narrative intervention designed to improve caregiver stress and communication.