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

75 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment PICU Journal for Critical Illness?

The development of a structured outcomes assessment and implementation program in the PICU has shown improvements in patient care by monitoring outcomes, identifying targets for improvement, and implementing new care protocols. This structured approach may indirectly support the effectiveness of treatments like PICU Journal by enhancing overall care quality in the PICU. ^{1 2 3 4 5}

What safety data exists for the treatment evaluated under PICU Journal for Critical Illness?

The research articles focus on adverse events (unintended and harmful events) in pediatric intensive care units (PICUs), highlighting the importance of monitoring and reporting to improve patient safety. They discuss the types, severity, and preventability of these events, which are crucial for understanding safety in PICU settings. ^{6 7 8 9 10}

How does this treatment for post-intensive care syndrome in children differ from other treatments?

The treatment is unique because it focuses on addressing the long-term physical, cognitive, and mental impairments that persist after discharge from the pediatric intensive care unit, which are not typically the focus of standard treatments. This approach aims to improve the overall recovery and quality of life for children and their families, which is a novel aspect compared to existing options. ^{11 12 13 14 15}

What is the purpose of this trial?

Admission to the pediatric intensive care unit (PICU) is well-recognized to be extremely distressing and stressful for the patient and family. As medical research and technology have advanced more and more children in the PICU are surviving, however in turn incurring new and persistent impairments across physical, cognitive, emotional, and social domains of health. This phenomenon is often referred to as post-intensive care syndrome (PICS). These impairments not only impact the patient but parents have also been found to have poor emotional health outcomes following discharge from the PICU. Consistently, parents/caregivers of children admitted to the PICU report their primary concerns to be 1) the overwhelming physical environment of the PICU, 2) uncertainty about the child's survivorship and outcomes, 3) relationships and communication with staff, and 4) feeling helpless. Additionally, research has shown that caregiver-perceived stress during the child's hospitalization positively predicts post-traumatic stress three months after discharge for parents/caregivers (Nelson et al., 2019), which may translate into higher risk and duration of post-traumatic stress in their children. Therefore, providing an in-hospital outlet such as a "PICU Journal" for patients and families to express their subjective experiences may help bridge the gap between perception and reality as a means of buffering against post-traumatic responses. Conceptually, a semi-structured journal intervention may integrate the therapeutic aspects of journaling while also providing pertinent information and serving as an advocacy and communication tool. Prior research has demonstrated the use of a "PICU Journal" is feasible for implementation and has been well-received by families of children in the PICU (Herrup et al., 2019). Therefore, the aims of this mixed-method study are to 1) examine the relationship between this journaling intervention and the perceived stress, care engagement, symptoms of anxiety, and depression, and the development of PICS in parents of children hospitalized in the PICU, and 2) examine the relationship between parent participation in this intervention and the development of PICS-p in children, and 3) assess the feasibility of this intervention from key stakeholders.

Research Team

Kristina Betters, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Review of Outcomes Used in Nutrition Trials in Pediatric Critical Care. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a Structured Outcomes Assessment and Implementation Program in the Pediatric Intensive Care Unit. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Neurologic Outcomes Following Care in the Pediatric Intensive Care Unit. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The impact of a quality improvement intervention to reduce nosocomial infections in a PICU. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pediatric Critical Care Outcomes: State of the Science. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events in pediatric intensive care units in the United States. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Incidence and nature of adverse drug events in paediatric intensive care units: A prospective multicentre study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Iatrogenic events contributing to paediatric intensive care unit admission. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Chronic critical illness and post-intensive care syndrome: from pathophysiology to clinical challenges. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Post Intensive Care Syndrome in Swiss Paediatric survivors and their Families (PICSS-PF): a national, multicentre, longitudinal study protocol. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

A strategy for development of paediatric intensive care within the United Kingdom. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Year in review 2006: Critical Care--Paediatrics. [2018]

15. England pubmed.ncbi.nlm.nih.gov

Narrative diaries in the paediatric intensive care unit: A thematic analysis. [2022]