Clinical trial NCT04989790: Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children
Official title: Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child
Intensive Care Unit Acquired Weakness
Critical Illness
Hospital Acquired Pressure Ulcer
Keywords: physical rehabilitation
post-intensive care syndrome
pediatric intensive care unit
sleep
sedation
delirium
physical therapy
occupational therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-08-04
Enrollment: 1440
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge cluster Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.


Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours at 7 a.m. on PICU Day 3

Exclusion Criteria:

* Active or anticipated withdrawal of life support within 48 hours
* Open chest or open abdomen
* Current use of Extracorporeal Membrane Oxygenation (ECMO)

Primary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: Through Day 21
Secondary outcomes:
measure: Proportion of Days with Delirium
timeFrame: Through Day 21
measure: Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale
timeFrame: Through Day 21
measure: Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale
timeFrame: Through Day 21
Other outcomes:
measure: PICU length of stay
timeFrame: Through Day 21
measure: Percentage of patients PICU mortality
timeFrame: Through Day 21
measure: Number of patients discharged to home
timeFrame: Through Day 21
measure: Number of patients discharged to inpatient floor
timeFrame: Through Day 21
measure: Number of patients discharged to inpatient rehabilitation
timeFrame: Through Day 21
measure: Number of patients discharged to other hospital
timeFrame: Through Day 21
measure: Percentage of patients with new pressure injuries
timeFrame: Through Day 21
measure: Percentage of patients with physical therapy consultation
timeFrame: Day 3
measure: Percentage of patients with occupational therapy consultation
timeFrame: Day 3
measure: Mean daily Opioid exposure
timeFrame: Through Day 21
measure: Mean daily Benzodiazepine exposure
timeFrame: Through Day 21
Locations:
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Orlando
country: United States
facility: Nemours Children's Hospital of the Nemours Foundation
state: Florida
city: Louisville
country: United States
facility: Norton Children's Hospital: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Minneapolis
country: United States
facility: Hennepin Healthcare: University of Minnesota
state: Minnesota
city: Lebanon
country: United States
facility: Children's Hospital at Dartmouth: Geisel School of Medicine
state: New Hampshire
city: Chapel Hill
country: United States
facility: UNC Children's: University of North Carolina
state: North Carolina
city: Danville
country: United States
facility: Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital: Baylor College of Medicine
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Medicine Children's: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Johns Hopkins University
name: Sapna Kudchadkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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