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3C-BASIC: Crisis Checklist Collaborative: Behavioral Analysis of Simulated Implementation of Crisis Checklists.


- candidate number25730
- NTR NumberNTR6666
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2016
- Secondary IDs 
- Public Title3C-BASIC: Crisis Checklist Collaborative: Behavioral Analysis of Simulated Implementation of Crisis Checklists.
- Scientific TitleBehavioral Analysis of Simulated Implementation of Crisis Checklists.
- ACRONYM3C-BASIC
- hypothesisWe hypothesize that usage of a crisis checklists in simulated patients will results in:
1. Better collaboration within exposed teams.
2. A reduction in the number of omitted safety critical steps.
3. Faster completion of safety critical tasks.
- Healt Condition(s) or Problem(s) studiedChecklist, Education, Medical crisis
- Inclusion criteria- Residents working on the emergency room or the wards of the intensive care, general surgery, internal medicine, pulmonology and cardiology.
- Nurses working on the emergency room or the wards of the intensive care, general surgery, internal medicine, pulmonology and cardiology.
- Written consent to participate as a volunteer with agreeing to audiovisual recordings.
- Exclusion criteria- Residents that have not worked for six months on one of the following departments: emergency room, intensive care, general surgery, internal medicine, pulmonology and cardiology.
- Nurses that have not worked for six months on one of the following departments: emergency room, intensive care, general surgery, internal medicine, pulmonology and cardiology.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate31-dec-2016
- Target number of participants32
- Interventions32 team will perform six scenarios. The teams start with three scenarios that will be completed by the local standard of care, followed by a tutorial and afterward three scenarios with a checklist of the crisis checklist app. The medical emergencies of the three scenarios match these three topics.
The topics of the checklists and medical emergencies will be:
- NEWS 7
- Respiratory distress
- Loss of consciousness
- Primary outcomeMeasures of teamwork
- Secondary outcomeUsability
Measures of timeliness
Completeness of response.
- TimepointsSimulated scenarios of 20 minutes.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES AJR De Bie Dekker
- CONTACT for SCIENTIFIC QUERIES AJR De Bie Dekker
- Sponsor/Initiator Crisis checklist collaboration
- Funding
(Source(s) of Monetary or Material Support)
Crisis checklist collaboration
- Publications
- Brief summaryBackground
Catastrophic deterioration of patients on general wards has been the focus of intense research over the last two decades. Much of focus has been on reducing ‘failure to rescue’ by creating rapid response systems in hospitals with improved mechanisms of escalation (‘afferent limb’). However, improvements for the efferent limb i.e. a consistent response to acute deterioration and patterns of abnormal patient physiology are still lacking.
This multicenter non-blinded randomized crossover simulation study will investigate how crisis checklists might aid to standardize the efferent limb of the rapid response system in an educational context. It will explore how these checklist function as a training and operational tool to improve the consistency and, therefore, efficacy of the assessments of the first responders that deal with patients in a “medical crisis”. In addition, the study will explore if these kind of checklists can improve the team performance of the first responders.

Method
Participants will be randomly assigned into two groups with a cross-over design. Both groups will start with performing three scenarios according to local standards of care, followed by a tutorial and performance of a further three scenarios with the availability of a crisis checklist. Participants will be residents, a nurses and senior medical and nursing students. All simulation will be performed in high fidelity simulation centers in participating European hospitals.

Endpoints
The primary endpoints will be measures of teamwork. The secondary endpoints will be the usability of the crisis checklists and measures of timeliness and completeness of response.

Hypothesis
We hypothesize that usage of a crisis checklists in simulated patients will results in:
1. Better collaboration within exposed teams.
2. A reduction in the number of omitted safety critical steps.
3. Faster completion of safety critical tasks.
- Main changes (audit trail)
- RECORD28-dec-2016 - 10-sep-2017


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