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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD103811 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale |
| Measure | Description | Time Frame |
|---|---|---|
| PICU length of stay | PICU length of stay days | Through Day 21 |
| Percentage of patients PICU mortality | PICU mortality | Through Day 21 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sapna R Kudchadkar, MD, PhD | Contact | 410-955-6412 | sapna@jhmi.edu | |
| Colleen Mennie, RN | Contact | 410-955-6412 | cmennie1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sapna Kudchadkar, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Children's Hospital | Recruiting | Madera | California | 93636 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27759596 | Background | 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. | |
| 33315754 | 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. |
| Label | URL |
|---|---|
| NIH Reporter Record of PICU Up! Trial | View source |
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Data generated in this grant will be presented in a timely fashion at national and international meetings and in publications. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. The investigators plan to share data from this research with other researchers who have interests in improving outcomes in critically ill children through early and progressive mobility interventions. Written proposals for data sharing requests will be accepted and reviewed by an independent review committee to ensure the proposal is scientifically and methodologically sound and not duplicative with other analyses. If approved, data sharing would occur after establishing a data use agreement with institutional signing authorities of each institution. Medical record and outcomes data will then be made available in the form of deidentified datasets with no identifiers in keeping with NIH Data Sharing Policy and Implementation Guidance.
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Stepped-wedge cluster Randomized Controlled Trial
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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 |
| 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 |
| Number of patients discharged to home | Number of patients discharged to home | Through Day 21 |
| Number of patients discharged to inpatient floor | Number of patients discharged to inpatient floor | Through Day 21 |
| Number of patients discharged to inpatient rehabilitation | Number of patients discharged to inpatient rehabilitation | Through Day 21 |
| Number of patients discharged to other hospital | Number of patients discharged to other hospital | Through Day 21 |
| Percentage of patients with new pressure injuries | Percentage of patients with new pressure injuries | Through Day 21 |
| Percentage of patients with physical therapy consultation | Physical therapy consultation by PICU | Day 3 |
| Percentage of patients with occupational therapy consultation | Occupational therapy consultation by PICU | Day 3 |
| Mean daily Opioid exposure | Opioid exposure: mean daily morphine and equivalents (mg/kg/day) via chart review | Through Day 21 |
| Mean daily Benzodiazepine exposure | Benzodiazepine exposure: mean daily benzodiazepine equivalents (mg/kg/day) via chart review | Through Day 21 |
| Nemours Children's Hospital of the Nemours Foundation | Recruiting | Orlando | Florida | 32827 | United States |
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| Norton Children's Hospital: University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Johns Hopkins Hospital | Active, not recruiting | Baltimore | Maryland | 21287 | United States |
| Hennepin Healthcare: University of Minnesota | Recruiting | Minneapolis | Minnesota | 55415 | United States |
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| Children's Hospital at Dartmouth: Geisel School of Medicine | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| UNC Children's: University of North Carolina | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Janet Weis Children's Hospital: Geisinger Commonwealth School of Medicine | Recruiting | Danville | Pennsylvania | 17822 | United States |
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| Texas Children's Hospital: Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| West Virginia University Medicine Children's: West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| Children's Hospital of Wisconsin: Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| 32168030 | 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. |
| 31073462 | 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. |
| 28079605 | 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. |
| 30460183 | 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. |
| 27134761 | 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. |
| 32576273 | 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. |
| 26380147 | 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;2015:129-170. doi: 10.1055/s-0035-1563386. Epub 2015 Sep 3. |
| 26362671 | 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. |
| 30885646 | 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. |
| 29357778 | 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. |
| 33116069 | 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. |
| 24717461 | 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. |
| 33763377 | 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. |
| 34086622 | 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. |
| 32869071 | 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. |
| 30946294 | 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. |
| 29394234 | 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. |
| 29394221 | 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. |
| 34046543 | 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. |
| 28821360 | 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. |
| 36918956 | Derived | 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. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| C000657744 | postintensive care syndrome |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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