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Trial record 2 of 71 for:    picu up

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

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ClinicalTrials.gov Identifier: NCT04989790
Recruitment Status : Recruiting
First Posted : August 4, 2021
Last Update Posted : September 10, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Child Intensive Care Unit Acquired Weakness Critical Illness Hospital Acquired Pressure Ulcer Other: PICU Up! Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped-wedge cluster Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial
Actual Study Start Date : August 8, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2026

Arm Intervention/treatment
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.
Other: PICU Up!
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.




Primary Outcome Measures :
  1. Duration of Mechanical Ventilation [ Time Frame: Through Day 21 ]
    In computing duration of mechanical ventilation, the investigators will consider Time 0 as the time of endotracheal intubation or PICU admission for patients intubated at an outside hospital, and continuing until the first time the endotracheal tube was continuously absent for at least 24 hours. Patients will be assigned 21 days for ventilation duration if they remain intubated and mechanically ventilated, are transferred to another facility while ventilated or die prior to day 21 without ever remaining off mechanical ventilation ventilation (via endotracheal tube) for more than 24 continuous hours. If a patient is transitioned to mechanical ventilation via a new tracheostomy those days will be counted as mechanical ventilation days.


Secondary Outcome Measures :
  1. Proportion of Days with Delirium [ Time Frame: Through Day 21 ]
    Defined as the number of days with delirium divided by the total number of days that the child is at risk for delirium (i.e. the number of days that the patient is in the PICU and free of coma and therefore assessable for delirium).

  2. Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale [ Time Frame: Through Day 21 ]
    The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's is a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.

  3. Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale [ Time Frame: Through Day 21 ]
    The Pediatric Overall Performance Category (POPC) is a global scale based on observer impressions. It's is a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.


Other Outcome Measures:
  1. PICU length of stay [ Time Frame: Through Day 21 ]
    PICU length of stay days

  2. Percentage of patients PICU mortality [ Time Frame: Through Day 21 ]
    PICU mortality

  3. Number of patients discharged to home [ Time Frame: Through Day 21 ]
    Number of patients discharged to home

  4. Number of patients discharged to inpatient floor [ Time Frame: Through Day 21 ]
    Number of patients discharged to inpatient floor

  5. Number of patients discharged to inpatient rehabilitation [ Time Frame: Through Day 21 ]
    Number of patients discharged to inpatient rehabilitation

  6. Number of patients discharged to other hospital [ Time Frame: Through Day 21 ]
    Number of patients discharged to other hospital

  7. Percentage of patients with new pressure injuries [ Time Frame: Through Day 21 ]
    Percentage of patients with new pressure injuries

  8. Percentage of patients with physical therapy consultation [ Time Frame: Day 3 ]
    Physical therapy consultation by PICU

  9. Percentage of patients with occupational therapy consultation [ Time Frame: Day 3 ]
    Occupational therapy consultation by PICU

  10. Mean daily Opioid exposure [ Time Frame: Through Day 21 ]
    Opioid exposure: mean daily morphine and equivalents (mg/kg/day) via chart review

  11. Mean daily Benzodiazepine exposure [ Time Frame: Through Day 21 ]
    Benzodiazepine exposure: mean daily benzodiazepine equivalents (mg/kg/day) via chart review



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Active or anticipated withdrawal of life support within 48 hours
  • Open chest or open abdomen
  • Current use of Extracorporeal Membrane Oxygenation (ECMO)

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): NCT04989790


Contacts
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Contact: Sapna R Kudchadkar, MD, PhD 410-955-6412 sapna@jhmi.edu
Contact: Colleen Mennie, RN 410-955-6412 cmennie1@jhmi.edu

Locations
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United States, California
Valley Children's Hospital Recruiting
Madera, California, United States, 93636
Contact: Molly Dorfman, MD         
Principal Investigator: Molly Dorfman, MD         
United States, Florida
Nemours Children's Hospital of the Nemours Foundation Recruiting
Orlando, Florida, United States, 32827
Contact: Mashael Alqahtani, MBBS, MS         
Principal Investigator: Mashael Alqahtani, MBBS, MS         
United States, Kentucky
Norton Children's Hospital: University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: John Berkenbosch, MD         
Principal Investigator: John Berkenbosch, MD         
Sub-Investigator: Melissa Porter, MD         
United States, Maryland
Johns Hopkins Hospital Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, Minnesota
Hennepin Healthcare: University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Andrew Kiragu, MD         
Sub-Investigator: Andrew Kiragu, MD         
Principal Investigator: Ashley Bjorklund, MD         
United States, New Hampshire
Children's Hospital at Dartmouth: Geisel School of Medicine Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Kelly Corbett, MD         
Principal Investigator: Kelly Corbett, MD         
United States, North Carolina
UNC Children's: University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Tracie Walker, MD         
Principal Investigator: Tracie Walker, MD         
United States, Pennsylvania
Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Justin Azar, MD         
Principal Investigator: Justin Azar, MD         
United States, Texas
Texas Children's Hospital: Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Matthew Musick, MD         
Principal Investigator: Matthew Musick, MD         
United States, West Virginia
West Virginia University Medicine Children's: West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mel Wright, DO         
Principal Investigator: Mel Wright, DO         
United States, Wisconsin
Children's Hospital of Wisconsin: Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Charles Rothschild, MD         
Principal Investigator: Charles Rothschild, MD         
Sponsors and Collaborators
Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Sapna Kudchadkar, MD, PhD Johns Hopkins University
Additional Information:
Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04989790    
Other Study ID Numbers: IRB00259937
R01HD103811 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data generated in this grant will be presented in a timely fashion at national and international meetings and in publications. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. The investigators plan to share data from this research with other researchers who have interests in improving outcomes in critically ill children through early and progressive mobility interventions. Written proposals for data sharing requests will be accepted and reviewed by an independent review committee to ensure the proposal is scientifically and methodologically sound and not duplicative with other analyses. If approved, data sharing would occur after establishing a data use agreement with institutional signing authorities of each institution. Medical record and outcomes data will then be made available in the form of deidentified datasets with no identifiers in keeping with NIH Data Sharing Policy and Implementation Guidance.

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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:
physical rehabilitation
post-intensive care syndrome
pediatric intensive care unit
sleep
sedation
delirium
physical therapy
occupational therapy
Additional relevant MeSH terms:
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Pressure Ulcer
Critical Illness
Disease Attributes
Pathologic Processes
Skin Ulcer
Skin Diseases