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

Primary Purpose

Child, Intensive Care Unit Acquired Weakness, Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PICU Up!
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Child focused on measuring physical rehabilitation, post-intensive care syndrome, pediatric intensive care unit, sleep, sedation, delirium, physical therapy, occupational therapy

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Valley Children's HospitalRecruiting
  • Nemours Children's Hospital of the Nemours FoundationRecruiting
  • Norton Children's Hospital: University of LouisvilleRecruiting
  • Johns Hopkins Hospital
  • Hennepin Healthcare: University of MinnesotaRecruiting
  • Children's Hospital at Dartmouth: Geisel School of MedicineRecruiting
  • UNC Children's: University of North CarolinaRecruiting
  • Janet Weis Children's Hospital: Geisinger Commonwealth School of MedicineRecruiting
  • Texas Children's Hospital: Baylor College of MedicineRecruiting
  • West Virginia University Medicine Children's: West Virginia UniversityRecruiting
  • Children's Hospital of Wisconsin: Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Baseline/Pre-implementation

Intervention/Post-implementation

Arm Description

Usual PICU care

PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility.

Outcomes

Primary Outcome Measures

Duration of Mechanical Ventilation
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

Proportion of Days with Delirium
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).
Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale
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.
Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale
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.

Full Information

First Posted
July 26, 2021
Last Updated
September 12, 2023
Sponsor
Johns Hopkins University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04989790
Brief Title
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children
Acronym
PICU Up!
Official Title
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Intensive Care Unit Acquired Weakness, Critical Illness, Hospital Acquired Pressure Ulcer
Keywords
physical rehabilitation, post-intensive care syndrome, pediatric intensive care unit, sleep, sedation, delirium, physical therapy, occupational therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge cluster Randomized Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline/Pre-implementation
Arm Type
No Intervention
Arm Description
Usual PICU care
Arm Title
Intervention/Post-implementation
Arm Type
Active Comparator
Arm Description
PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility.
Intervention Type
Other
Intervention Name(s)
PICU Up!
Intervention Description
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 Measure Information:
Title
Duration of Mechanical Ventilation
Description
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.
Time Frame
Through Day 21
Secondary Outcome Measure Information:
Title
Proportion of Days with Delirium
Description
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).
Time Frame
Through Day 21
Title
Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale
Description
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.
Time Frame
Through Day 21
Title
Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale
Description
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.
Time Frame
Through Day 21
Other Pre-specified Outcome Measures:
Title
PICU length of stay
Description
PICU length of stay days
Time Frame
Through Day 21
Title
Percentage of patients PICU mortality
Description
PICU mortality
Time Frame
Through Day 21
Title
Number of patients discharged to home
Description
Number of patients discharged to home
Time Frame
Through Day 21
Title
Number of patients discharged to inpatient floor
Description
Number of patients discharged to inpatient floor
Time Frame
Through Day 21
Title
Number of patients discharged to inpatient rehabilitation
Description
Number of patients discharged to inpatient rehabilitation
Time Frame
Through Day 21
Title
Number of patients discharged to other hospital
Description
Number of patients discharged to other hospital
Time Frame
Through Day 21
Title
Percentage of patients with new pressure injuries
Description
Percentage of patients with new pressure injuries
Time Frame
Through Day 21
Title
Percentage of patients with physical therapy consultation
Description
Physical therapy consultation by PICU
Time Frame
Day 3
Title
Percentage of patients with occupational therapy consultation
Description
Occupational therapy consultation by PICU
Time Frame
Day 3
Title
Mean daily Opioid exposure
Description
Opioid exposure: mean daily morphine and equivalents (mg/kg/day) via chart review
Time Frame
Through Day 21
Title
Mean daily Benzodiazepine exposure
Description
Benzodiazepine exposure: mean daily benzodiazepine equivalents (mg/kg/day) via chart review
Time Frame
Through Day 21

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sapna R Kudchadkar, MD, PhD
Phone
410-955-6412
Email
sapna@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Mennie, RN
Phone
410-955-6412
Email
cmennie1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sapna Kudchadkar, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Dorfman, MD
First Name & Middle Initial & Last Name & Degree
Molly Dorfman, MD
Facility Name
Nemours Children's Hospital of the Nemours Foundation
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mashael Alqahtani, MBBS, MS
First Name & Middle Initial & Last Name & Degree
Mashael Alqahtani, MBBS, MS
Facility Name
Norton Children's Hospital: University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Berkenbosch, MD
First Name & Middle Initial & Last Name & Degree
John Berkenbosch, MD
First Name & Middle Initial & Last Name & Degree
Melissa Porter, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hennepin Healthcare: University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Kiragu, MD
First Name & Middle Initial & Last Name & Degree
Andrew Kiragu, MD
First Name & Middle Initial & Last Name & Degree
Ashley Bjorklund, MD
Facility Name
Children's Hospital at Dartmouth: Geisel School of Medicine
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Corbett, MD
First Name & Middle Initial & Last Name & Degree
Kelly Corbett, MD
Facility Name
UNC Children's: University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracie Walker, MD
First Name & Middle Initial & Last Name & Degree
Tracie Walker, MD
Facility Name
Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Azar, MD
First Name & Middle Initial & Last Name & Degree
Justin Azar, MD
Facility Name
Texas Children's Hospital: Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Musick, MD
First Name & Middle Initial & Last Name & Degree
Matthew Musick, MD
Facility Name
West Virginia University Medicine Children's: West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mel Wright, DO
First Name & Middle Initial & Last Name & Degree
Mel Wright, DO
Facility Name
Children's Hospital of Wisconsin: Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Rothschild, MD
First Name & Middle Initial & Last Name & Degree
Charles Rothschild, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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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PubMed Identifier
27759596
Citation
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Links:
URL
https://reporter.nih.gov/search/-TyQWv1coE2q0PsxZLOP-Q/project-details/10097465
Description
NIH Reporter Record of PICU Up! Trial

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

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