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

NCT04989790 | Recruiting DMC

• 2 other identifiers: IRB00297110R01HD103811
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

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

Keywords

physical rehabilitation; post-intensive care syndrome; pediatric intensive care unit; sleep; sedation; delirium; physical therapy; occupational therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of Days with Delirium

  Through Day 21

• Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale

  Through Day 21

• Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale

  Through Day 21

Other Outcomes (11)

• PICU length of stay

  Through Day 21

• Percentage of patients PICU mortality

  Through Day 21

• Number of patients discharged to home

  Through Day 21

Study Arms (2)

Baseline/Pre-implementation

NO INTERVENTION

Usual PICU care

Intervention/Post-implementation

ACTIVE COMPARATOR

PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility.

Other: PICU Up!

Interventions

PICU Up! OTHER

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.

Intervention/Post-implementation

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (11)

Valley Children's Hospital

Madera, California, 93636, United States

RECRUITING

Nemours Children's Hospital of the Nemours Foundation

Orlando, Florida, 32827, United States

RECRUITING

Norton Children's Hospital: University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

ACTIVE NOT RECRUITING

Hennepin Healthcare: University of Minnesota

Minneapolis, Minnesota, 55415, United States

RECRUITING

Children's Hospital at Dartmouth: Geisel School of Medicine

Lebanon, New Hampshire, 03756, United States

RECRUITING

UNC Children's: University of North Carolina

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine

Danville, Pennsylvania, 17822, United States

RECRUITING

Texas Children's Hospital: Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

West Virginia University Medicine Children's: West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Children's Hospital of Wisconsin: Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (23)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32168030 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28079605 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 26380147 BACKGROUND

• 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.

  PMID: 26362671 BACKGROUND

• 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.

  PMID: 30885646 BACKGROUND

• 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.

  PMID: 29357778 BACKGROUND

• 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.

  PMID: 33116069 BACKGROUND

• 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.

  PMID: 24717461 BACKGROUND

• 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.

  PMID: 33763377 BACKGROUND

• 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.

  PMID: 34086622 BACKGROUND

• 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.

  PMID: 32869071 BACKGROUND

• 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.

  PMID: 30946294 BACKGROUND

• 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.

  PMID: 29394234 BACKGROUND

• 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.

  PMID: 29394221 BACKGROUND

• 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.

  PMID: 34046543 BACKGROUND

• 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.

  PMID: 28821360 BACKGROUND

• Azamfirei R, Mennie C, Dinglas VD, Fatima A, Colantuoni E, Gurses AP, Balas MC, Needham DM, Kudchadkar SR; on behalf of the PICU Up! Investigators. Impact of a multifaceted early mobility intervention for critically ill children - the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial. Trials. 2023 Mar 15;24(1):191. doi: 10.1186/s13063-023-07206-2.

  PMID: 36918956 DERIVED

Related Links

• NIH Reporter Record of PICU Up! Trial

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sapna Kudchadkar, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sapna R Kudchadkar, MD, PhD

CONTACT

410-955-6412; sapna@jhmi.edu

Colleen Mennie, RN

CONTACT

410-955-6412; cmennie1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster Randomized Controlled Trial

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: August 8, 2022
• Primary Completion: August 11, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (11)