Clinical trial NCT03860168: PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Official title: PICU Up!:A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: sleep
sedation
early mobilization
acute rehabilitation
delirium
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Donaghue Medical Research Foundation
First posted: 2019-03-01
Enrollment: 2500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Duration of mechanical ventilation (days)
timeFrame: 28 days
Secondary outcomes:
measure: PICU length of stay (days)
timeFrame: 28 days
measure: Hospital length of stay (days)
timeFrame: 28 days
measure: Proportion of patients receiving out-of-bed mobility before PICU Day 28
timeFrame: 28 days
measure: Number of patients discharged directly to home from the PICU
timeFrame: 28 days
measure: Number of patients discharged from the hospital to a place other than home
timeFrame: 28 days
measure: Incidence of venous thromboembolism
timeFrame: 28 days
measure: Incidence of pressure injury
timeFrame: 28 days
measure: Cumulative exposure to opioids (mg/kg) through PICU Day 28
timeFrame: 28 days
measure: Cumulative exposure to benzodiazepines (mg/kg) through PICU Day 28
timeFrame: 28 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sapna R Kudchadkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/PCC.0000000000000983.
citation: 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.
citation: 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.