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

Critical Illness Clinical Trial

— PICU Up!  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989790
• Other study ID #: IRB00259937
• Secondary ID: R01HD103811
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Sapna R Kudchadkar, MD, PhD
• Phone: 410-955-6412
• Email: sapna[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Child
• Critical Illness
• Hospital Acquired Pressure Ulcer
• Intensive Care Unit Acquired Weakness
• Pressure Ulcer

Intervention

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 rounds. The intervention facilitates daily discussion of 1) analgesia; 2) extubation readiness testing; 3) sedation level and goal; 4) delirium screening and management; 5) mobility goal including physical and occupational therapy consultation by PICU Day 3; 6) sleep promotion; and 7) family engagement in mobility.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	UNC Children's: University of North Carolina	Chapel Hill	North Carolina
United States	Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine	Danville	Pennsylvania
United States	Texas Children's Hospital: Baylor College of Medicine	Houston	Texas
United States	Children's Hospital at Dartmouth: Geisel School of Medicine	Lebanon	New Hampshire
United States	Norton Children's Hospital: University of Louisville	Louisville	Kentucky
United States	Valley Children's Hospital	Madera	California
United States	Children's Hospital of Wisconsin: Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hennepin Healthcare: University of Minnesota	Minneapolis	Minnesota
United States	West Virginia University Medicine Children's: West Virginia University	Morgantown	West Virginia
United States	Nemours Children's Hospital of the Nemours Foundation	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (22)

Ames SG, Alessi LJ, Chrisman M, Stanger M, Corboy D, Sinha A, Fink EL. Development and Implementation of Pediatric ICU-based Mobility Guidelines: A Quality Improvement Initiative. Pediatr Qual Saf. 2021 May 19;6(3):e414. doi: 10.1097/pq9.0000000000000414. eCollection 2021 May-Jun. — View Citation

Betters KA, Hebbar KB, Farthing D, Griego B, Easley T, Turman H, Perrino L, Sparacino S, deAlmeida ML. Development and implementation of an early mobility program for mechanically ventilated pediatric patients. J Crit Care. 2017 Oct;41:303-308. doi: 10.1016/j.jcrc.2017.08.004. Epub 2017 Aug 9. — View Citation

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. — View Citation

Choong K, Fraser D, Al-Harbi S, Borham A, Cameron J, Cameron S, Cheng J, Clark H, Doherty T, Fayed N, Gorter JW, Herridge M, Khetani M, Menon K, Seabrook J, Simpson R, Thabane L. Functional Recovery in Critically Ill Children, the "WeeCover" Multicenter Study. Pediatr Crit Care Med. 2018 Feb;19(2):145-154. doi: 10.1097/PCC.0000000000001421. — View Citation

Choong K, Zorko DJ, Awojoodu R, Ducharme-Crevier L, Fontela PS, Lee LA, Guerguerian AM, Garcia Guerra G, Krmpotic K, McKelvie B, Menon K, Murthy S, Sehgal A, Weiss MJ, Kudchadkar SR. Prevalence of Acute Rehabilitation for Kids in the PICU: A Canadian Multicenter Point Prevalence Study. Pediatr Crit Care Med. 2021 Feb 1;22(2):181-193. doi: 10.1097/PCC.0000000000002601. — View Citation

Denlinger K, Young DL, Beier M, Friedman M, Quinn J, Hoyer EH, Kudchadkar SR. Psychometric Testing of the Activity Measure for Post-Acute Care (AM-PAC) in the Pediatric Acute Care Setting. Pediatr Phys Ther. 2021 Jul 1;33(3):149-154. doi: 10.1097/PEP.0000000000000807. — View Citation

Fayed N, Cameron S, Fraser D, Cameron JI, Al-Harbi S, Simpson R, Wakim M, Chiu L, Choong K. Priority Outcomes in Critically Ill Children: A Patient and Parent Perspective. Am J Crit Care. 2020 Sep 1;29(5):e94-e103. doi: 10.4037/ajcc2020188. — View Citation

Flaigle MC, Ascenzi J, Kudchadkar SR. Identifying Barriers to Delirium Screening and Prevention in the Pediatric ICU: Evaluation of PICU Staff Knowledge. J Pediatr Nurs. 2016 Jan-Feb;31(1):81-4. doi: 10.1016/j.pedn.2015.07.009. Epub 2015 Sep 9. — View Citation

Ghafoor S, Fan K, Williams S, Brown A, Bowman S, Pettit KL, Gorantla S, Quillivan R, Schwartzberg S, Curry A, Parkhurst L, James M, Smith J, Canavera K, Elliott A, Frett M, Trone D, Butrum-Sullivan J, Barger C, Lorino M, Mazur J, Dodson M, Melancon M, Hall LA, Rains J, Avent Y, Burlison J, Wang F, Pan H, Lenk MA, Morrison RR, Kudchadkar SR. Beginning Restorative Activities Very Early: Implementation of an Early Mobility Initiative in a Pediatric Onco-Critical Care Unit. Front Oncol. 2021 Mar 8;11:645716. doi: 10.3389/fonc.2021.645716. eCollection 2021. — View Citation

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. — View Citation

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. — View Citation

Kudchadkar SR, Aljohani O, Johns J, Leroux A, Alsafi E, Jastaniah E, Gottschalk A, Shata NJ, Al-Harbi A, Gergen D, Nadkarni A, Crainiceanu C. Day-Night Activity in Hospitalized Children after Major Surgery: An Analysis of 2271 Hospital Days. J Pediatr. 2019 Jun;209:190-197.e1. doi: 10.1016/j.jpeds.2019.01.054. Epub 2019 Mar 15. — View Citation

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: 10.1097/CCM.0000000000004291. — View Citation

Kudchadkar SR, Yaster M, Punjabi NM. Sedation, sleep promotion, and delirium screening practices in the care of mechanically ventilated children: a wake-up call for the pediatric critical care community*. Crit Care Med. 2014 Jul;42(7):1592-600. doi: 10.1097/CCM.0000000000000326. — View Citation

Merritt C, Menon K, Agus MSD, Choong K, McNally D, O'Hearn K, Watson RS, Wong HR, Duffett M, Wypij D, Zimmerman JJ. Beyond Survival: Pediatric Critical Care Interventional Trial Outcome Measure Preferences of Families and Healthcare Professionals. Pediatr Crit Care Med. 2018 Feb;19(2):e105-e111. doi: 10.1097/PCC.0000000000001409. — View 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. — View Citation

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. — View Citation

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 International Point Prevalence Study. Crit Care Med. 2017 Apr;45(4):584-590. doi: 10.1097/CCM.0000000000002250. — View Citation

Treble-Barna A, Beers SR, Houtrow AJ, Ortiz-Aguayo R, Valenta C, Stanger M, Chrisman M, Orringer M, Smith CM, Pollon D, Duffett M, Choong K, Watson RS, Kochanek PM, Fink EL; PICU-Rehabilitation Study Group, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, and Prevalence of Acute critical Neurological disease in children: A Global Epidemiological Assessment (PANGEA) Investigators. PICU-Based Rehabilitation and Outcomes Assessment: A Survey of Pediatric Critical Care Physicians. Pediatr Crit Care Med. 2019 Jun;20(6):e274-e282. doi: 10.1097/PCC.0000000000001940. — View Citation

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. — View 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. — View Citation

Wieczorek B, Burke C, Al-Harbi A, Kudchadkar SR. Early mobilization in the pediatric intensive care unit: a systematic review. J Pediatr Intensive Care. 2015;2015(4):129-170. doi: 10.1055/s-0035-1563386. Epub 2015 Sep 3. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PICU length of stay	PICU length of stay days	Through Day 21
Other	Percentage of patients PICU mortality	PICU mortality	Through Day 21
Other	Number of patients discharged to home	Number of patients discharged to home	Through Day 21
Other	Number of patients discharged to inpatient floor	Number of patients discharged to inpatient floor	Through Day 21
Other	Number of patients discharged to inpatient rehabilitation	Number of patients discharged to inpatient rehabilitation	Through Day 21
Other	Number of patients discharged to other hospital	Number of patients discharged to other hospital	Through Day 21
Other	Percentage of patients with new pressure injuries	Percentage of patients with new pressure injuries	Through Day 21
Other	Percentage of patients with physical therapy consultation	Physical therapy consultation by PICU	Day 3
Other	Percentage of patients with occupational therapy consultation	Occupational therapy consultation by PICU	Day 3
Other	Mean daily Opioid exposure	Opioid exposure: mean daily morphine and equivalents (mg/kg/day) via chart review	Through Day 21
Other	Mean daily Benzodiazepine exposure	Benzodiazepine exposure: mean daily benzodiazepine equivalents (mg/kg/day) via chart review	Through Day 21
Primary	Duration of Mechanical Ventilation	In computing duration of mechanical ventilation, the investigators will consider Time 0 as the time of endotracheal intubation or PICU admission for patients intubated at an outside hospital, and continuing until the first time the endotracheal tube was continuously absent for at least 24 hours. Patients will be assigned 21 days for ventilation duration if they remain intubated and mechanically ventilated, are transferred to another facility while ventilated or die prior to day 21 without ever remaining off mechanical ventilation ventilation (via endotracheal tube) for more than 24 continuous hours. If a patient is transitioned to mechanical ventilation via a new tracheostomy those days will be counted as mechanical ventilation days.	Through Day 21
Secondary	Proportion of Days with Delirium	Defined as the number of days with delirium divided by the total number of days that the child is at risk for delirium (i.e. the number of days that the patient is in the PICU and free of coma and therefore assessable for delirium).	Through Day 21
Secondary	Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale	The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's is a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.	Through Day 21
Secondary	Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale	The Pediatric Overall Performance Category (POPC) is a global scale based on observer impressions. It's is a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.	Through Day 21

External Links

•   NIH Reporter Record of PICU Up! Trial