Clinical Effectiveness of the PICU Up! Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

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

Locations
United States
California
Valley Children's Hospital
RECRUITING
Madera
Florida
Nemours Children's Hospital of the Nemours Foundation
RECRUITING
Orlando
Kentucky
Norton Children's Hospital: University of Louisville
RECRUITING
Louisville
Maryland
Johns Hopkins Hospital
ACTIVE_NOT_RECRUITING
Baltimore
Minnesota
Hennepin Healthcare: University of Minnesota
RECRUITING
Minneapolis
North Carolina
UNC Children's: University of North Carolina
RECRUITING
Chapel Hill
New Hampshire
Children's Hospital at Dartmouth: Geisel School of Medicine
RECRUITING
Lebanon
Pennsylvania
Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine
RECRUITING
Danville
Texas
Texas Children's Hospital: Baylor College of Medicine
RECRUITING
Houston
Wisconsin
Children's Hospital of Wisconsin: Medical College of Wisconsin
RECRUITING
Milwaukee
West Virginia
West Virginia University Medicine Children's: West Virginia University
RECRUITING
Morgantown
Contact Information
Primary
Sapna R Kudchadkar, MD, PhD
sapna@jhmi.edu
410-955-6412
Backup
Colleen Mennie, RN
cmennie1@jhmi.edu
410-955-6412
Time Frame
Start Date: 2022-08-08
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 1440
Treatments
No_intervention: Baseline/Pre-implementation
Usual PICU care
Active_comparator: Intervention/Post-implementation
PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility.
Related Therapeutic Areas
Sponsors
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov