PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
- Conditions
- Critical Illness
- Interventions
- Other: PICU Up!
- Registration Number
- NCT03860168
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PICU Up! pre- and post-implementation PICU Up! 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.
- Primary Outcome Measures
Name Time Method Duration of mechanical ventilation (days) 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
Name Time Method Number of patients discharged directly to home from the PICU 28 days PICU length of stay (days) 28 days Number of patients discharged from the hospital to a place other than home 28 days Number of patients discharged from the hospital to a place other than home (rehabilitation facility) if previous residence was home
Cumulative exposure to benzodiazepines (mg/kg) through PICU Day 28 28 days Hospital length of stay (days) 28 days Proportion of patients receiving out-of-bed mobility before PICU Day 28 28 days Incidence of venous thromboembolism 28 days Cumulative exposure to opioids (mg/kg) through PICU Day 28 28 days Incidence of pressure injury 28 days
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States