Clinical Effectiveness of the “PICU Up!” Multifaceted Early Mobility Intervention for Critically Ill Children

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, inter-professional 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.

ClinicalTrials.gov Identifier: NCT04989790

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

Institution Hospital Name Site PI
Baylor College of Medicine Texas Children's Hospital Matthew Musick, MD
Geisel School of Medicine at Dartmouth College Children's Hospital at Dartmouth Kelly Corbett, MD
Geisinger Commonwealth School of Medicine Janet Weis Children's Hospital Elizabeth Scarlett, MD
Medical College of Wisconsin Children's Hospital of Wisconsin Charles Rothschild, MD
Stanford University Valley Children's Hospital Molly Dorfman, MD, MPH
University of Central Florida Nemours Children's Hospital Mashael Alqahtani, MBBS, MS
University of Louisville Norton Children's Hospital John Berkenbosch, MD
University of Minnesota Hennepin Healthcare Andrew Kiragu, MD
University of North Carolina UNC Children's Hospital Tracie Walker, MD
West Virginia University WVU Medicine Children's Hospital Mel Wright, DO

Principal Investigator & Clinical Coordinating Center Chair: Sapna Kudchadkar, MD, PhD (sapna@jhmi.edu) 

Data Coordinating Center Chair: Dale Needham, MD, PhD

Clinical Coordinating Center Project Manager: Colleen Mennie, RN (cmennie1@jhmi.edu)

Data Coordinating Center Manager: Victor Dinglas, MPH