PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critica… (NCT03860168) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
United States2,500 participantsStarted 2019-04-01
Plain-language 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.
Who can participate
Age range
0 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on early mobility for critically ill children on mechanical ventilation — can you help me understand what 'early mobility' actually means in practice for a child in the PICU, and whether that kind of activity would be realistic given my child's current condition?
2Since this is listed as 'active, not recruiting,' does that mean my child can no longer enroll, and are there similar early mobility programs already being used here in the PICU that we could still benefit from?
3The trial is measuring how early movement affects the number of days a child spends on a ventilator — based on what you've seen or read so far, do you think early mobility is something that could genuinely help my child, or are there reasons it might not be appropriate for their specific situation?
4This study doesn't have a traditional phase, which suggests it's more about testing how to deliver the program than proving a drug is safe — does that mean the risks are different from a typical clinical trial, and what should I know about any potential risks of moving a critically ill child earlier than usual?
5Are there standard PICU care practices or other studies you'd recommend we consider alongside or instead of this intervention, especially if early mobility isn't the right fit for my child right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.