PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: PICU Up! pre- and post-implementation 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!
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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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 [28 days]
Number of patients discharged from the hospital to a place other than home (rehabilitation facility) if previous residence was home
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria for Participating Units:
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
- Donaghue Medical Research Foundation
Investigators
- Principal Investigator: Sapna R Kudchadkar, MD, PhD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
- Miura S, Wieczorek B, Lenker H, Kudchadkar SR. Normal Baseline Function Is Associated With Delayed Rehabilitation in Critically Ill Children. J Intensive Care Med. 2020 Apr;35(4):405-410. doi: 10.1177/0885066618754507. Epub 2018 Jan 22.
- Pun BT, Balas MC, Barnes-Daly MA, Thompson JL, Aldrich JM, Barr J, Byrum D, Carson SS, Devlin JW, Engel HJ, Esbrook CL, Hargett KD, Harmon L, Hielsberg C, Jackson JC, Kelly TL, Kumar V, Millner L, Morse A, Perme CS, Posa PJ, Puntillo KA, Schweickert WD, Stollings JL, Tan A, D'Agostino McGowan L, Ely EW. Caring for Critically Ill Patients with the ABCDEF Bundle: Results of the ICU Liberation Collaborative in Over 15,000 Adults. Crit Care Med. 2019 Jan;47(1):3-14. doi: 10.1097/CCM.0000000000003482.
- Wieczorek B, Ascenzi J, Kim Y, Lenker H, Potter C, Shata NJ, Mitchell L, Haut C, Berkowitz I, Pidcock F, Hoch J, Malamed C, Kravitz T, Kudchadkar SR. PICU Up!: Impact of a Quality Improvement Intervention to Promote Early Mobilization in Critically Ill Children. Pediatr Crit Care Med. 2016 Dec;17(12):e559-e566.
- IRB00199373
- 789