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PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children

NCT ID: NCT03860168

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness

Keywords

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sleep sedation early mobilization acute rehabilitation delirium

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

PICU Up!

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


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

* Patients with an active do-not-resuscitate (DNR) order will be excluded.
Minimum Eligible Age

0 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sapna R Kudchadkar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27759596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29357778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30339549 (View on PubMed)

Azamfirei R, Behrens D, Padilla S, Madden K, Goldberg S, Geno M, Manning MJ, Piole M, Madsen E, Maue D, Abu-Sultaneh S, Awojoodu R, Wang NY, Needham DM, Neufeld K, Kudchadkar SR. Delirium Screening in Critically Ill Children: Secondary Analysis of the Multicenter PICU Up! Pilot Trial Dataset, 2019-2020. Pediatr Crit Care Med. 2024 Oct 1;25(10):880-888. doi: 10.1097/PCC.0000000000003555. Epub 2024 Jun 4.

Reference Type DERIVED
PMID: 38832837 (View on PubMed)

Other Identifiers

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789

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00199373

Identifier Type: -

Identifier Source: org_study_id