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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06117345
Status
Enrolling By Invitation

Conditions

  • Critical Illness

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Jun 2026
Primary completion
Jul 15, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Parents/Caregivers
    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
  • No Intervention: Patients
    Pediatric patients ages 8 to 18 years whose parents/caregivers participated in the PICU journal intervention
  • No Intervention: PICU providers and staff
    PICU providers and staff who observed or participated in the PICU journal intervention during its use with parents/caregivers

Primary Outcome Measure

Parent/Caregiver reported stress level [ Time Frame: At study enrollment (T1), within 48 hours of child's discharge from hospital (T2) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Monroe Carell Jr. Children's Hospital at VanderbiltNashvilleTennessee37232-

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Monroe Carell Jr. Children's Hospital at Vanderbilt· Nashville, TN

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