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

Johns Hopkins University

Status: Active, not recruiting

Conditions: Critical Illness

Treatments: Other: PICU Up!

Study type: Interventional

Funder types: Other

Identifiers

NCT03860168

IRB00199373

789 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: Under 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,500 participants in 1 patient group

PICU Up! pre- and post-implementation

Other group

Description:

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.

Treatment:

Other: PICU Up!