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PICU Up!: Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children (PICU Up!)

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ClinicalTrials.gov Identifier: NCT03860168
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
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!: Impact of a Multifaceted Early Mobility Intervention on Clinical Outcomes and ICU-acquired Morbidities in Critically Ill Children
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

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 ]


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Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Contacts
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Contact: Sapna R Kudchadkar, MD, PhD 410-955-6412 sapna@jhmi.edu
Contact: Ronke Awojoodu, RN 410-955-6412 ronke@jhu.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Sapna R Kudchadkar, MD    410-955-6412    sapna@jhmi.edu   
Contact: Pam Melvin, RN    410-955-6412    pam@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Donaghue Medical Research Foundation
Investigators
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Principal Investigator: Sapna R Kudchadkar, MD, PhD Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03860168     History of Changes
Other Study ID Numbers: IRB00199373
789 ( Other Identifier: Other )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
sleep
sedation
early mobilization
acute rehabilitation
delirium

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes