Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study

University of Pennsylvania755 enrolled

Overview

Pediatric Intensive Care Unit (PICU) survival has increased substantially over the past three decades. Currently, an understanding of PICU morbidity and recovery among PICU survivors and their families is limited. Post-intensive care syndrome (PICS) consists of new or worsening impairments in physical, cognitive, or mental health status that arise and may persist after critical illness. The characteristics of PICS in children (PICS-p) are unknown. The objective of this study is to learn about pediatric recovery from critical illness to guide future intervention research to optimize child and family health.

PICS-p is a prospective longitudinal cohort study of pediatric patients experiencing 3 or more days of intensive care therapies at one of approximately 30 U.S. PICUs to evaluate child and family outcomes over two years post-PICU discharge. We will compare outcomes of these PICU patients with a control group of patients who received an overnight PICU stay but did not receive intensive care therapies, as well as with published quality of life data from the general and chronically ill populations. Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff, and their post-discharge outcomes will be followed centrally from the University of Pennsylvania and the Seattle Children's Research Institute. Our specific aims are to determine the physical, cognitive, emotional, and social health outcomes and trajectory of recovery in a population of children post-critical illness; to determine the baseline health, presenting problem, and PICU factors associated with impaired physical, cognitive, emotional, and social outcomes among PICU survivors; and to determine the emotional and social health outcomes in parents and siblings of PICU survivors. Our primary goal is to explicate the impact of pediatric critical illness over a two-year period of time to guide future intervention research to optimize child and family outcomes. Our overall goal is to improve the health and well-being of PICU survivors and their families.

Study Type

OBSERVATIONAL

Enrollment

755

Conditions

Critical Illness

Eligibility

Sex: ALLMin age: 1 MonthMax age: 16 Years

Medical Language ↔ Plain English

Case Inclusion criteria: 1. Current admission is the child's first PICU (including pediatric subspecialty ICU) admission 2. Patient age ≥4 weeks and ≥44 weeks corrected gestational age and \<16 years (has not yet reached 16th birthday) on PICU admission 3. At least one parent/legal guardian (≥18 years of age or considered emancipated) living with the potential subject 4. PICU LOS of 3 days (covering at least 3 nights from midnight to 7am) in which the patient received intensive care therapies for organ dysfunction (for example, invasive mechanical ventilation, vasopressors/inotropes, acute renal replacement therapy, or other extracorporeal therapies). 5. Anticipated patient discharge to home (directly or indirectly after a stay in another facility) Case Exclusion criteria: 1. Patient history of neonatal intensive care unit hospitalization 2. Life expectancy not anticipated to be more than one year (e.g., active do not resuscitate \[DNR\] plan or actively managed by the palliative care team for end-of-life symptom management) 3. Patient in foster care or ward of the state Control subjects: As above but will be PICU patients who received an overnight PICU stay (\<36 hours covering one midnight to 7am time period) that did not include intensive care therapies. Post-operative children who were intubated/extubated in the operating room/PACU (or intubated in the operating room and extubated in the PICU on arrival and prior to parent presence at the bedside) can be enrolled as control subjects. Control subjects will be frequency matched to cases on age group, sex, and medical complexity, that is, complex chronic disease (C-CD), noncomplex chronic disease (NC-CD), and without CD on a 2:1 case:control ratio. Family Subjects: At least one eligible parent/legal guardian must be willing to participate. In addition, up to two cognitively capable siblings (PCPC of 1 or 2) aged 8 to \<16 years, who live with the patient, and who have not been ICU hospitalized will be invited to participate. If more than two siblings are eligible, the two siblings with the next birthday (regardless of birth year) will be invited to participate.

Outcomes

Primary Outcomes

Health related quality of life (HRQOL) - Patient

PedsQL™ 4.0 Generic Core or Infant Scales (self report)

Time frame: Two years

Health related quality of life (HRQOL) - Parent

PedsQL™ 4.0 Generic Core or Infant Scales (parent report)

Time frame: Two years

Secondary Outcomes

Fatigue - Patient

PedsQL™ Multidimensional Fatigue Scale v3.0 (self report)

Time frame: Two Years

Fatigue - Parent

PedsQL™ Multidimensional Fatigue Scale v3.0 (parent report)

Time frame: Two Years

Sleep - Patient

PROMIS Pediatric Sleep Disturbance - Short Form 4a and Pediatric Sleep-Related Impairment - Short Form 4a (self report)

Time frame: Two Years

Sleep - Parent

PROMIS Sleep Disturbance - Short Form 4a and Sleep-Related Impairment - Short Form 4a (parent report)

Time frame: Two Years

Cognitive Functioning - Patient

PedsQL™ Cognitive Functioning Scale and Pediatric Cerebral Performance Category (PCPC)

Time frame: Two Years

Cognitive Functioning - Parent

PedsQL™ Cognitive Functioning Scale (parent report) and Pediatric Cerebral Performance Category (PCPC) (parent report)

Time frame: Two Years

Pain - Patient

PedsQL™ Pediatric Pain Questionnaire and PROMIS Pediatric Pain Interference - Short Form 8a (self report)

Time frame: Two Years

Post Traumatic Stress Disorder (PTSD)- Patient

Child PTSD Symptom Scale for DSM-5 (CPSS-V) (self report)

Time frame: Two Years

Post Traumatic Stress Disorder (PTSD)- Parent

Young Child PTSD Screen - Revised PICU (YCPS R - PICU) (parent report); PTSD Checklist for DSM-5 (PCL-5) (parent report)

Time frame: Two Years

Strengths and Difficulties - Patient

Strengths and Difficulties Questionnaire (SDQ)

Time frame: Two Years

Strengths and Difficulties - Sibling

Strengths and Difficulties Questionnaire (SDQ)

Time frame: Two Years

Hope - Patient

Children's Hope Scale (CHS)

Time frame: Two Years

Hope - Sibling

Children's Hope Scale (CHS)

Time frame: Two Years

Growth and Development - Patient

Survey of Well-being of Young Children (SWYC) - Milestones only (parent report)

Time frame: Two Years

Functional status - Patient

Functional Status Scale (FSS) and Pediatric Overall Performance Category (POPC) (parent report)

Time frame: Two Years

Family impact

PedsQL™ Family Impact Module v2.0 (parent report)

Time frame: Two years

Growth - Parent

Post-traumatic Growth Inventory - Short Form (PTGI-SF) (parent self report)

Time frame: Two Years

Depression - Parent

Patient Health Questionnaire-4 (PHQ-4) (parent self report)

Time frame: Two years

HRQOL - Sibling

PedsQL Version 4.0 Generic Core Scales (sibling self report)

Time frame: Two Years

Caregiving - Sibling

Multidimensional Assessment of Caring Activities (MACA-YC18) (sibling self report)

Time frame: Two Years

Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study

Overview

Conditions

Eligibility

Locations (30)

Outcomes

Primary Outcomes

Secondary Outcomes