In-hospital Cardiac ArrestSAMURAI PICUNCT06553534
Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU
A study testing SAMURAI PICU Bundle in people with In-hospital Cardiac Arrest and Cardiopulmonary Resuscitation, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- In-hospital Cardiac Arrest, Cardiopulmonary Resuscitation
- What is being tested?
- SAMURAI PICU Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2024to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the five PICUs in pediRES-Q during the study period
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Akron Children's Hospital
Akron, Ohio, 44308
MUSC Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425
Comer Children's Hospital
Chicago, Illinois, 60637
Children's Hospital of Richmond
Richmond, Virginia, 23219
Seattle Children's
Seattle, Washington, 98105
About this study
Official title: Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU in the Pediatric Resuscitation Quality Collaborative
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?
Read more
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
Read the 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).
- Being tested
- SAMURAI PICU Bundle
- Keywords
- situational awareness, Cardiac Arrest, Cardiopulmonary Resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAMURAI PICU BundleOther
Also called SAMURAI Bundle
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness - CPR Event Rate
The primary outcome is CPR Event Rate per 1000 Patient Days. CPR Events will be defined per Utstein Criteria.
Measured: 2 years and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jan 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for In-hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Adaptive Hybrid Stepped-wedge
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Maya L Dewan, MD, MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553534
- Sponsor's protocol ID
- SAMURAI_23-021338
- Other IDs
- 1R18HS029630-01
- Acronym
- SAMURAI PICU
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38378044Gifford 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.
PubMed 37792360Dewan 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.
PubMed 34417417Soberano 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.
PubMed 32853138
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU in the Pediatric Resuscitation Quality Collaborative
- ClinicalTrials.gov ID
- NCT06553534
- Acronym / sponsor ID
- SAMURAI PICU / SAMURAI_23-021338
- Keywords
- situational awareness, Cardiac Arrest, Cardiopulmonary Resuscitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Adaptive Hybrid Stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Site A | Experimental | Other: SAMURAI PICU BundleSite 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. |
| Site B | Experimental | Other: SAMURAI PICU BundleSite 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 |
| Site C | Experimental | Other: SAMURAI PICU BundleSite 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. |
| Site D | Experimental | Other: SAMURAI PICU BundleSite 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the five PICUs in pediRES-Q during the study period
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAMURAI PICU BundleAlso: SAMURAI BundleThe 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. | Other | Site A, Site B, Site C, Site D |
Primary outcome
Effectiveness - CPR Event Rate
Time frame: 2 years and 4 years
The primary outcome is CPR Event Rate per 1000 Patient Days. CPR Events will be defined per Utstein Criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 38378044Molloy 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.
- Background: PubMed 37792360Gifford 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.
- Background: PubMed 34417417Dewan 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.
- Background: PubMed 32853138Soberano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya L Dewan, MD, MPH principal investigator
Children's Hospital Medical Center, Cincinnati
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAMURAI PICU Bundle in people with In-hospital Cardiac Arrest and Cardiopulmonary Resuscitation, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness - CPR Event Rate (time frame: 2 years and 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553534, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.