Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU

NCT06553534 | Active Not Recruiting

• 2 other identifiers: SAMURAI_23-0213381R18HS029630-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this pragmatic prospective Type 1 Hybrid Implementation-Effectiveness Trial study is to learn if The Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In (SAMURAI) the PICU Bundle can reduce PICU CPR events. The SAMURAI PICU Bundle includes an automated PICU warning tool, twice daily huddles and mitigation plans. The main questions it aims to answer are: Is the adapted bundle will be acceptable, feasible, and appropriate to stakeholders prior to implementation? Will there be at least a 30% relative reduction in PICU CPR events following successful implementation of the bundle? Each site will: Adapt and implement SAMURAI PICU Bundle which includes an automated PICU warning tool, twice daily huddles and mitigation plans

Conditions

In-hospital Cardiac Arrest; Cardiopulmonary Resuscitation

Keywords

situational awareness; Cardiac Arrest; Cardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

• Effectiveness - CPR Event Rate

  The primary outcome is CPR Event Rate per 1000 Patient Days. CPR Events will be defined per Utstein Criteria.

  2 years and 4 years

Study Arms (5)

Site A

EXPERIMENTAL

Site A will begin a transition period of no more than 6 months (while continuing to collect baseline data). During the transition period, the local study team will receive education about the intervention and help tailor the tools and materials to fit their institutional needs. Upon completion of the transition period, Site A will immediately begin the intervention period. They will then remain in the intervention period (using the SAMURAI Bundle) for the remaining study period.

Other: SAMURAI PICU Bundle

Site B

EXPERIMENTAL

Site B will begin a control period of approximately 6 months, during which they will continue to collect data while operating under their institutional standards (No SAMURAI Intervention). At the end of the control period, they will start a transition period of up to 6 months, during which time they will receive education and adapt the tools and materials to fit their institutional needs. At the conclusion of the transition period, they will begin implementing the study intervention (usage of the SAMURAI bundle) for the remaining study period

Other: SAMURAI PICU Bundle

Site C

EXPERIMENTAL

Site C will begin a control period of approximately 1 year, during which they will continue to collect data while operating under their institutional standards (No SAMURAI Intervention). At the end of the control period, they will start a transition period of up to 6 months, during which time they will receive education and adapt the tools and materials to fit their institutional needs. At the conclusion of the transition period, they will begin implementing the study intervention (usage of the SAMURAI bundle) for the remaining study period.

Other: SAMURAI PICU Bundle

Site D

EXPERIMENTAL

Site D will begin a control period of approximately 1.5 years, during which they will continue to collect data while operating under their institutional standards (No SAMURAI Intervention). At the end of the control period, they will start a transition period of up to 6 months, during which time they will receive education and adapt the tools and materials to fit their institutional needs. At the conclusion of the transition period, they will begin implementing the study intervention (usage of the SAMURAI bundle) for the remaining study period.

Other: SAMURAI PICU Bundle

Site E

NO INTERVENTION

Site E will serve as our control group for the study period, operating according to their institutional standard of care (No intervention) while continuing to collect data.

Interventions

SAMURAI PICU Bundle OTHER

The proposed multifaceted SAMURAI PICU Bundle is an intervention with the following core elements: 1) PICU Warning Tool: an automated clinical decision support (CDS) tool to provide a non-interruptive interprofessional predictive alert, 2) twice daily safety huddles with unit leadership, and 3) bedside assessment including the care team and patient's family to complete and display a bedside mitigation plan to prevent deterioration. This intervention combines the automated accurate prediction of the PICU Warning Tool with the use of provider intuition or a "gut feeling" from huddles to improve decision making at the bedside. Peripheral elements and possible adaptations will be suggested during Aim 1 and additional peripheral elements may be added by local sites after discussion with the PI through a user-centered design approach.

Also known as: SAMURAI Bundle

Site A; Site B; Site C; Site D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the five PICUs in pediRES-Q during the study period

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Children's Hospital of Philadelphia: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (5)

Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

MUSC Shawn Jenkins Children's Hospital

Charleston, South Carolina, 29425, United States

Location

Children's Hospital of Richmond

Richmond, Virginia, 23219, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

Related Publications (4)

• Molloy MJ, Zackoff M, Gifford A, Hagedorn P, Tegtmeyer K, Britto MT, Dewan M. Usability Testing of Situation Awareness Clinical Decision Support in the Intensive Care Unit. Appl Clin Inform. 2024 Mar;15(2):327-334. doi: 10.1055/a-2272-6184. Epub 2024 Feb 20.

  PMID: 38378044 BACKGROUND

• Gifford A, Butcher B, Chima RS, Moore L, Brady PW, Zackoff MW, Dewan M. Use of design thinking and human factors approach to improve situation awareness in the pediatric intensive care unit. J Hosp Med. 2023 Nov;18(11):978-985. doi: 10.1002/jhm.13216. Epub 2023 Oct 4.

  PMID: 37792360 BACKGROUND

• Dewan M, Soberano B, Sosa T, Zackoff M, Hagedorn P, Brady PW, Chima RS, Stalets EL, Moore L, Britto M, Sutton RM, Nadkarni V, Tegtmeyer K, Wolfe H. Assessment of a Situation Awareness Quality Improvement Intervention to Reduce Cardiac Arrests in the PICU. Pediatr Crit Care Med. 2022 Jan 1;23(1):4-12. doi: 10.1097/PCC.0000000000002816.

  PMID: 34417417 BACKGROUND

• Soberano BT, Brady P, Yunger T, Jones R, Stoneman E, Sosa T, Stalets EL, Zackoff M, Chima R, Tegtmeyer K, Dewan M. The Effects of Care Team Roles on Situation Awareness in the Pediatric Intensive Care Unit: A Prospective Cross-Sectional Study. J Hosp Med. 2020 Oct;15(10):594-597. doi: 10.12788/jhm.3449.

  PMID: 32853138 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Maya L Dewan, MD, MPH

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptive Hybrid Stepped-wedge

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

US (5)