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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Other: PICU Up!


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PICU Up! pre- and post-implementation<br>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!<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation (days) | Defined as the number of days of mechanical ventilation through an endotracheal tube during the first 28 days of PICU admission. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PICU length of stay (days) |  | 28 days | 
| Hospital length of stay (days) |  | 28 days | 
| Proportion of patients receiving out-of-bed mobility before PICU Day 28 |  | 28 days | 
| Number of patients discharged directly to home from the PICU |  | 28 days | 
| Number of patients discharged from the hospital to a place other than home | Number of patients discharged from the hospital to a place other than home (rehabilitation facility) if previous residence was home | 28 days | 
| Incidence of venous thromboembolism |  | 28 days | 
| Incidence of pressure injury |  | 28 days | 
| Cumulative exposure to opioids (mg/kg) through PICU Day 28 |  | 28 days | 
| Cumulative exposure to benzodiazepines (mg/kg) through PICU Day 28 |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, sedation, early mobilization, acute rehabilitation, delirium