SAMURAI Program for Reducing Cardiac Arrests in Pediatric ICU (SAMURAI PICU Trial)

N/A

Waitlist Available

Led By Maya L Dewan, MD, MPH

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years and 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a program called SAMURAI can reduce the number of CPR events in the pediatric intensive care unit (PICU). SAMURAI includes a warning tool, regular team meetings

Who is the study for?

This trial is for pediatric ICU teams. It's designed to see if the SAMURAI PICU Bundle, which includes a warning tool and team meetings twice daily, can reduce the need for CPR in critically ill children.

What is being tested?

The study tests the 'SAMURAI PICU Bundle' intervention aimed at reducing cardiac arrests in pediatric ICUs. The bundle involves an automated alert system and structured team discussions about patient care plans.

What are the potential side effects?

Since this trial focuses on process improvements rather than medications, traditional side effects are not applicable. However, there may be challenges with integrating new procedures into existing workflows.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years and 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years and 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness - CPR Event Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Site DExperimental Treatment1 Intervention

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.

Group II: Site CExperimental Treatment1 Intervention

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.

Group III: Site BExperimental Treatment1 Intervention

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

Group IV: Site AExperimental Treatment1 Intervention

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.

Group V: Site EActive Control1 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.

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