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

Part of paid clinical trials in Madera, California.

Sponsor
Johns Hopkins University
Study ID
NCT04989790
Status
Recruiting
Apply to this trial

Conditions

  • Child
  • Critical Illness
  • Hospital Acquired Pressure Ulcer
  • Intensive Care Unit Acquired Weakness

Eligibility Criteria

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

Interventions

  • PICU Up! — OTHER
    PICU Up! incorporates the screening process for determining a patient's appropriate activity level into the daily rounding workflow for all PICU patients, with a tiered activity plan based on clinical parameters to individualize goals based on each child's unique needs. While the patient's PICU Up! level is based on objective criteria, the interprofessional team collectively determines the daily activity goal(s) through shared decision-making which is documented in the medical record on morning rounds. The intervention facilitates daily discussion of 1) analgesia; 2) extubation readiness testing; 3) sedation level and goal; 4) delirium screening and management; 5) mobility goal including physical and occupational therapy consultation by PICU Day 3; 6) sleep promotion; and 7) family engagement in mobility.

Study Details

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.

Key Dates

Start date
Aug 8, 2022
Status verified
Mar 2026
Primary completion
Aug 11, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
1,440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.

Primary Outcome Measure

Duration of Mechanical Ventilation [ Time Frame: Through Day 21 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Valley Children's HospitalMaderaCalifornia93636
Molly Dorfman, MD
Molly Dorfman, MD (PRINCIPAL_INVESTIGATOR)
Nemours Children's Hospital of the Nemours FoundationOrlandoFlorida32827
Mashael Alqahtani, MBBS, MS
Mashael Alqahtani, MBBS, MS (PRINCIPAL_INVESTIGATOR)
Norton Children's Hospital: University of LouisvilleLouisvilleKentucky40202
John Berkenbosch, MD
John Berkenbosch, MD (PRINCIPAL_INVESTIGATOR)
Melissa Porter, MD (SUB_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287-
Hennepin Healthcare: University of MinnesotaMinneapolisMinnesota55415
Andrew Kiragu, MD
Andrew Kiragu, MD (SUB_INVESTIGATOR)
Ashley Bjorklund, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital at Dartmouth: Geisel School of MedicineLebanonNew Hampshire03756
Kelly Corbett, MD
Kelly Corbett, MD (PRINCIPAL_INVESTIGATOR)
UNC Children's: University of North CarolinaChapel HillNorth Carolina27514
Tracie Walker, MD
Tracie Walker, MD (PRINCIPAL_INVESTIGATOR)
Janet Weis Children's Hospital: Geisinger Commonwealth School of MedicineDanvillePennsylvania17822
Justin Azar, MD
Justin Azar, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's Hospital: Baylor College of MedicineHoustonTexas77030
Matthew Musick, MD
Matthew Musick, MD (PRINCIPAL_INVESTIGATOR)
West Virginia University Medicine Children's: West Virginia UniversityMorgantownWest Virginia26506
Mel Wright, DO
Mel Wright, DO (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Wisconsin: Medical College of WisconsinMilwaukeeWisconsin53226
Charles Rothschild, MD
Charles Rothschild, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Madera, CA

By research site
Valley Children's Hospital· Madera, CANemours Children's Hospital of the Nemours Foundation· Orlando, FLNorton Children's Hospital: University of Louisville· Louisville, KYJohns Hopkins Hospital· Baltimore, MDHennepin Healthcare: University of Minnesota· Minneapolis, MNChildren's Hospital at Dartmouth: Geisel School of Medicine· Lebanon, NH

Related Studies