We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children (PICU Up!)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03860168
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : July 7, 2022
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Recent decreases in Pediatric Intensive Care Unit (PICU) mortality rates have been offset by increased morbidity and length of stay for vulnerable young patients. Heavy sedation, bedrest, and delirium contribute to a PICU culture of immobility. While studies in adult ICU patients demonstrate the clinical benefits of early mobilization, fewer than 25% of critically ill children mobilize early in the children's PICU stay. The investigators have demonstrated the safety and feasibility of the 'PICU Up!' Mobility Program, which integrates sleep promotion, delirium prevention, sedation optimization as a bundle to increase mobilization. However, the generalizability and broader impact on patient- and family-centered outcomes is unknown. Therefore, there is an urgent need for trials that blend both clinical effectiveness and implementation research to create a PICU culture of mobility and improve the value of PICU care. The overall objective of the proposed research is to determine the impact of a transdisciplinary and multifaceted early mobility program on clinical outcomes and ICU-acquired morbidities in critically ill children. Additionally, the investigators will identify barriers and facilitators to high-performance bundle adoption.

Condition or disease Intervention/treatment Phase
Critical Illness Other: PICU Up! Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: The study will be conducted using a pragmatic stepped-wedge cluster randomized trial (RCT) design, with each PICU acting as one cluster. In a traditional stepped-wedge (TSW) design, all clusters begin in the control group and then transition to the intervention group at sequential and randomly assigned periods, facilitating the delivery of a desired intervention to all clusters, in this case, all participating PICUs.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PICU Up!:A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
PICU Up! pre- and post-implementation
Each unit will begin in the baseline, usual care phase and then be randomized to implement the PICU Up! program during a set time period, followed by the post-implementation phase.
Other: PICU Up!
The PICU Up! intervention is a multifaceted mobility program incorporating the ABCDEF bundle components into routine PICU care through multidisciplinary staff education and a structured pathway to determine a patient's daily mobility goal. PICU Up! was developed by a collaborative multidisciplinary team approach, and the central components include the consultation and involvement of physical therapy/occupational therapy (PT/OT) by PICU Day 3, sleep hygiene promotion and routine delirium screening for all PICU patients utilizing a validated tool.

Primary Outcome Measures :
  1. Duration of mechanical ventilation (days) [ Time Frame: 28 days ]
    Defined as the number of days of mechanical ventilation through an endotracheal tube during the first 28 days of PICU admission.

Secondary Outcome Measures :
  1. PICU length of stay (days) [ Time Frame: 28 days ]
  2. Hospital length of stay (days) [ Time Frame: 28 days ]
  3. Proportion of patients receiving out-of-bed mobility before PICU Day 28 [ Time Frame: 28 days ]
  4. Number of patients discharged directly to home from the PICU [ Time Frame: 28 days ]
  5. Number of patients discharged from the hospital to a place other than home [ Time Frame: 28 days ]
    Number of patients discharged from the hospital to a place other than home (rehabilitation facility) if previous residence was home

  6. Incidence of venous thromboembolism [ Time Frame: 28 days ]
  7. Incidence of pressure injury [ Time Frame: 28 days ]
  8. Cumulative exposure to opioids (mg/kg) through PICU Day 28 [ Time Frame: 28 days ]
  9. Cumulative exposure to benzodiazepines (mg/kg) through PICU Day 28 [ Time Frame: 28 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   0 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria for Participating Units:

  • Participating PICUs must be a separate physical space dedicated to the care of critically ill infants and children, with the ability to provide mechanical ventilation.
  • Not implemented a PICU mobility protocol and would commit to not implementing a mobility protocol until the randomized time of unit implementation.

Inclusion Criteria for Patients:

All patients admitted to the PICUs regardless of length of stay will receive the unit-based PICU Up! intervention, which includes criteria for no mobilization based on specific clinical factors (i.e. open chest, surgeon request).10 For inclusion in data analysis, patients will be eligible if

  • Admitted to the participating PICU ≥ 3 days.

Exclusion Criteria for Patients:

  • Patients with an active do-not-resuscitate (DNR) order will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860168

Layout table for location information
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Donaghue Medical Research Foundation
Layout table for investigator information
Principal Investigator: Sapna R Kudchadkar, MD, PhD Johns Hopkins University
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03860168    
Other Study ID Numbers: IRB00199373
789 ( Other Identifier: Other )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
early mobilization
acute rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes