PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children (PICU Up!)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03860168|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : July 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Other: PICU Up!||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||PICU Up!:A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children|
|Actual Study Start Date :||April 1, 2019|
|Actual Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||December 31, 2022|
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.
Other: 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.
- Duration of mechanical ventilation (days) [ Time Frame: 28 days ]Defined as the number of days of mechanical ventilation through an endotracheal tube during the first 28 days of PICU admission.
- PICU length of stay (days) [ Time Frame: 28 days ]
- Hospital length of stay (days) [ Time Frame: 28 days ]
- Proportion of patients receiving out-of-bed mobility before PICU Day 28 [ Time Frame: 28 days ]
- Number of patients discharged directly to home from the PICU [ Time Frame: 28 days ]
- Number of patients discharged from the hospital to a place other than home [ Time Frame: 28 days ]Number of patients discharged from the hospital to a place other than home (rehabilitation facility) if previous residence was home
- Incidence of venous thromboembolism [ Time Frame: 28 days ]
- Incidence of pressure injury [ Time Frame: 28 days ]
- Cumulative exposure to opioids (mg/kg) through PICU Day 28 [ Time Frame: 28 days ]
- Cumulative exposure to benzodiazepines (mg/kg) through PICU Day 28 [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860168
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Sapna R Kudchadkar, MD, PhD||Johns Hopkins University|