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

Study Overview
=================
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.

Official Title
-----------------
Clinical Effectiveness of the PICU Up! Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial

Conditions
-----------------
Child, Intensive Care Unit Acquired Weakness, Critical Illness, Hospital Acquired Pressure Ulcer

Intervention / Treatment
-----------------
* Other: PICU Up!


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped-wedge cluster Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline/Pre-implementation<br>Usual PICU care | |
| Active Comparator: Intervention/Post-implementation<br>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!<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Through Day 21 | 
| 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. | Through Day 21 | 
| 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. | Through Day 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical rehabilitation, post-intensive care syndrome, pediatric intensive care unit, sleep, sedation, delirium, physical therapy, occupational therapy