Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children

Official title

Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial

Overview

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.

Interventions

• Other PICU Up!
  PICU Up! incorporates the screening process for determining a patient's appropriate activity level into the daily rounding workflow for all PICU patients, with a tiered activity plan based on clinical parameters to individualize goals based on each child's unique needs. While the patient's PICU Up! level is based on objective criteria, the interprofessional team collectively determines the daily activity goal(s) through shared decision-making which is documented in the medical record on morning

Primary outcome measures

• Duration of Mechanical Ventilation [Time frame: Through Day 21]

Secondary outcome measures (3)

• Proportion of Days with Delirium [Time frame: Through Day 21]
• Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale [Time frame: Through Day 21]
• Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale [Time frame: Through Day 21]

Eligibility criteria

Inclusion criteria

• Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours at 7 a.m. on PICU Day 3

Exclusion criteria

• Active or anticipated withdrawal of life support within 48 hours
• Open chest or open abdomen
• Current use of Extracorporeal Membrane Oxygenation (ECMO)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 11 centers

• Valley Children's Hospital — Madera
• Nemours Children's Hospital of the Nemours Foundation — Orlando
• Norton Children's Hospital: University of Louisville — Louisville
• Johns Hopkins Hospital — Baltimore
• Hennepin Healthcare: University of Minnesota — Minneapolis
• Children's Hospital at Dartmouth: Geisel School of Medicine — Lebanon
• UNC Children's: University of North Carolina — Chapel Hill
• Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine — Danville
• … and 3 more centers

Publications

• 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. PMID 27759596
• Patel RV, Redivo J, Nelliot A, Eakin MN, Wieczorek B, Quinn J, Gurses AP, Balas MC, Needham DM, Kudchadkar SR. Early Mobilization in a PICU: A Qualitative Sustainability Analysis of PICU Up! Pediatr Crit Care Med. 2021 Apr 1;22(4):e233-e242. doi: 10.1097/PCC.0000000000002619. PMID 33315754
• Kudchadkar SR, Nelliot A, Awojoodu R, Vaidya D, Traube C, Walker T, Needham DM; Prevalence of Acute Rehabilitation for Kids in the PICU (PARK-PICU) Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Physical Rehabilitation in Critically Ill Children: A Multicenter Point Prevalence Study in the United States. Crit Care Med. 2020 May;48(5):634-644. doi: 10.1 PMID 32168030
• Choong K, Canci F, Clark H, Hopkins RO, Kudchadkar SR, Lati J, Morrow B, Neu C, Wieczorek B, Zebuhr C. Practice Recommendations for Early Mobilization in Critically Ill Children. J Pediatr Intensive Care. 2018 Mar;7(1):14-26. doi: 10.1055/s-0037-1601424. Epub 2017 Apr 10. PMID 31073462
• Traube C, Silver G, Reeder RW, Doyle H, Hegel E, Wolfe HA, Schneller C, Chung MG, Dervan LA, DiGennaro JL, Buttram SD, Kudchadkar SR, Madden K, Hartman ME, deAlmeida ML, Walson K, Ista E, Baarslag MA, Salonia R, Beca J, Long D, Kawai Y, Cheifetz IM, Gelvez J, Truemper EJ, Smith RL, Peters ME, O'Meara AM, Murphy S, Bokhary A, Greenwald BM, Bell MJ. Delirium in Critically Ill Children: An Internatio PMID 28079605
• Walker TC, Kudchadkar SR. Early mobilization in the pediatric intensive care unit. Transl Pediatr. 2018 Oct;7(4):308-313. doi: 10.21037/tp.2018.09.02. PMID 30460183
• Hopkins RO, Choong K, Zebuhr CA, Kudchadkar SR. Transforming PICU Culture to Facilitate Early Rehabilitation. J Pediatr Intensive Care. 2015 Dec;4(4):204-211. doi: 10.1055/s-0035-1563547. PMID 27134761
• Ista E, Scholefield BR, Manning JC, Harth I, Gawronski O, Bartkowska-Sniatkowska A, Ramelet AS, Kudchadkar SR; EU PARK-PICU Collaborators. Mobilization practices in critically ill children: a European point prevalence study (EU PARK-PICU). Crit Care. 2020 Jun 24;24(1):368. doi: 10.1186/s13054-020-02988-2. PMID 32576273

Identifiers

NCT: NCT04989790 · IRB00297110 · R01HD103811

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗