Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A PICU Journal

NCT06117345 | Enrolling By Invitation DMC

• 1 other identifier: 231386
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness

Keywords

Critical care; Intensive care; Pediatrics; Family-Centered Care; Family Engagement; PICU Liberation

Outcome Measures

Primary Outcomes (8)

• Parent/Caregiver reported stress level

  Score on the Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit; 7 Likert type items scored from 1 to 5, with 1 being "not stressful" and 5 being "extremely stressful." Composite scores can range from 0 (not experienced) to 35 (extremely stressful).

  At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)

• Parent/Caregiver care engagement level

  Score on the Caregiving Health Engagement Scale; 7 items with four answer choices scored from 1 to 4. Composite scores can range from 7 (minimal engagement) to 28 (high engagement).

  At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)

• Parent/Caregiver reported depression and anxiety symptoms

  Score on the Hospital Anxiety and Depression Scale; two subscales (anxiety and depression) with 7 items each. Items have 4 answer choices scored from 1 to 4, with higher numbers indicating higher alignment with anxiety or depression. Cut scores are used to determine clinical significance; a total score of less than 7 on a subscale indicates a non-case, 8-10 on a subscale indicates mild, 11-14 indicates moderate, and 15 to 21 is considered severe.

  within 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)

• Parent/caregiver reported impact of events

  Score on Impact of Events Scale-Revised; 20 Likert-type items scored from 0 (not experienced) to 4 (extremely distressed). Total composite scores can range from 0 (not experienced) to 80 (extremely distressed).

  at 3 months post-discharge (T3)

• Parent/Caregiver use of and satisfaction with PICU journal

  Responses to a descriptive survey created by research team to assess frequency/type of PICU journal use and completion, as well as parent/caregiver perceptions of feasibility and utility

  within 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)

• Child reported impact of events

  Score on the Child Revised Impact of Events Scale; 8 items with four answer choices scored from 0 (not at all) to 3 (often). Total composite scores can range from 0 (not at all distressed) t to 24 (extremely distressed).

  at 3 months post-discharge (T3)

• Parent/caregiver Experiences Interview

  Responses to semi-structured interview about PICU journal perceptions and experiences (in-person, by phone, or by teleconference)

  at 3 months post-discharge (T3)

• PICU Staff perceptions of PICU journal intervention

  Responses to a descriptive survey created by research team to collect perceptions about and level of engagement with PICU journal intervention

  Through study completion, an expected average of 2 years

Study Arms (3)

Parents/Caregivers

EXPERIMENTAL

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

Behavioral: PICU Journal

Patients

NO INTERVENTION

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

PICU providers and staff

NO INTERVENTION

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

Interventions

PICU Journal BEHAVIORAL

A hard-copy, customizable educational/therapeutic/expressive journal for parents/caregivers to seek information and document their child's PICU experiences and outcomes.

Also known as: PICU diary

Parents/Caregivers

Eligibility Criteria

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

You may qualify if:

• The participant is a primary caregiver of a pediatric patient (ages 1 month to 21 years) admitted to the pediatric intensive care unit (PICU) at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV)
• The participant's child meets the criteria for Levels 1 or 2 of the Early Mobility Protocol at MCJCHV
• The participant's child has been hospitalized in the PICU for between 24 and 72 hours at the time of informed consent.
• The participant has not had prior experience with their child(ren) being admitted to the PICU.
• The participant is proficient in reading and writing the English language.

You may not qualify if:

• The participant is unwilling to provide consent.
• The participant is unable to read and write in the English language.
• The child participant is between the ages of 8 to 17 years.
• The participant is proficient in reading and writing the English language.
• The participant is unwilling to provide assent.
• The participant is unable to read and write in the English language.
• The participant(s) interact with patients in the PICU at Monroe Carell Jr. Children's Hospital at Vanderbilt.
• The participant is proficient in reading and writing the English language.
• \- The participant is unable to read and write in the English language.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Vanderbilt University: collaborator

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina Betters, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-PI

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 7, 2023
• Study Start: May 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)