Clinical trial NCT06553534: Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU
Official title: Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU in the Pediatric Resuscitation Quality Collaborative
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: In-hospital Cardiac Arrest
Cardiopulmonary Resuscitation
Keywords: situational awareness
Cardiac Arrest
Cardiopulmonary Resuscitation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-08-14
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Adaptive Hybrid Stepped-wedge
Primary purpose: PREVENTION

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

Detailed description: As nearly 95% of pediatric IHCAs occur in PICUs, we developed an interventional cardiac arrest prevention bundle targeted to PICU healthcare providers. In a previous single center trial, the use of the SAMURAI PICU bundle improved early identification of high-risk patients, increased shared situation awareness, and supported risk mitigation plans, leading to a \>50% decrease in IHCA events requiring cardiopulmonary resuscitation (CPR). Early identification occurs via the PICU Warning Tool, an automated, electronic medical record clinical decision support tool that provides a non-interruptive notification to care providers of high-risk patients. This prediction tool prompts a bedside huddle to ensure shared situation awareness and development of a mitigation plan. This novel approach of emphasizing shared situation awareness through automated clinical decision support and mitigation of risk has demonstrated reduction in CPR events and mortality within the PICU clinical environment.

This study employs a user-centered design model to adapt, implement, and assess the feasibility and effectiveness of SAMURAI PICU at other pediatric institutions. The hypothesis is that identification of PICU patients at high risk for IHCA through the use of the PICU Warning Tool and integration of this high-risk status in daily safety huddles will lead to improved shared situation awareness and subsequent reduction in CPR events at participating institutions. This approach will utilize a five-center pragmatic prospective Hybrid Type 1 effectiveness-implementation study leveraging the existing infrastructure of Pediatric Resuscitation Quality Collaborative (pediRES-Q).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Effectiveness - CPR Event Rate
timeFrame: 2 years and 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Comer Children's Hospital
state: Illinois
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: MUSC Shawn Jenkins Children's Hospital
state: South Carolina
city: Richmond
country: United States
facility: Children's Hospital of Richmond
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Maya L Dewan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.