PICU Up!: Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 24 |
| Updated: | 3/3/2019 |
| Start Date: | April 1, 2019 |
| End Date: | April 30, 2021 |
| Contact: | Sapna R Kudchadkar, MD, PhD |
| Email: | sapna@jhmi.edu |
| Phone: | 410-955-6412 |
PICU Up!: Impact of a Multifaceted Early Mobility Intervention on Clinical Outcomes and ICU-acquired Morbidities in Critically Ill Children
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.
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.
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.
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