Influence of checklists on the processing of medical emergencies in simulation
Organizational Data
- DRKS-ID:
- DRKS00024781
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-03-16
- Last update in DRKS:
- 2023-01-04
- Registration type:
- Retrospective
Acronym/abbreviation of the study
PROCESSION
URL of the study
No Entry
Brief summary in lay language
The influence of checklists on the processing of medical emergencies will be investigated during high-fidelity simulation
Brief summary in scientific language
Monocenter randomized controlled trial in postgraduate courses on emergency and critical care medicine. The primary outcome variable was error rate reduction of critical workflows for each emergency. Secondary endpoints included a survey of participants' perceptions of the usefulness and clinical relevance of the checklists, prior medical and emergency medicine knowledge, prior experience with checklists, error rate separated by gender of team leader, total scenario time, total time "away from patient," confidence, influence of experience and specialization, quality of checklist, quality of emergency scenarios, acceptance of checklists. In addition, the promotion of the participants' subjective sense of safety and the influence of the checklists on the interaction during the scenario were evaluated. All data are analyzed on an intention-to-treat basis.
Health condition or problem studied
- ICD10:
- I46 - Cardiac arrest
- ICD10:
- I47.2 - Ventricular tachycardia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Course participants of postgraduate training in simulated medical emergencies WITH emergency medical checklists.
- Arm 2:
- Course participants of postgraduate training in simulated medical emergencies WITHOUT emergency medical checklists.
Endpoints
- Primary outcome:
- Error rate reduction of critical workflows for each simulated emergency.
- Secondary outcome:
- Perception of usefulness and clinical relevance of the checklists, prior medical and emergency medical knowledge, prior experience with checklists, error rate separated by gender of the team leader, total time of the scenario, total time "away from the patient", self-confidence, influence of experience and specialization, quality of the checklist, quality of the emergency scenarios, acceptance of the checklists. In addition, the promotion of the participants' subjective sense of safety and the influence of the checklists on the interaction during the scenario were evaluated. All data are analyzed on an intention-to-treat basis.
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Kaiserhaus Arnsberg - Neheim
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2020-03-28
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-06-25
- Target Sample Size:
- 640
- Final Sample Size:
- 512
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- Postgraduate course participant, Certified physician, Informed consent for study
Exclusion Criteria
Non-consent, Pregnancy
Addresses
Primary Sponsor
- Address:
- Arbeitsgemeinschaft Intensivmedizin (AIM) ArnsbergDr. med. Dietmar WetzchewaldApothekerstrasse 2759755 ArnsbergGermany
- Telephone:
- +49 2932 700 105
- Fax:
- +49 2932 700 139
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://aim-arnsberg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität Duisburg-EssenProfessor Dr. med. Frank BreuckmannHufelandstr. 2745127 EssenGermany
- Telephone:
- +49 2602 684-225
- Fax:
- +49 2602 684-227
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.krankenhaus-dernbach.de/medizinische-bereiche/medizinische-fachabteilungen/medizinische-klinik-i
Contact for Public Queries
- Address:
- Medizinische Klinik IHerz-Jesu-KrankenhausSamer AlchabSüdring 856428 DernbachGermany
- Telephone:
- +49 2602 684-225
- Fax:
- +49 2602 684-227
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.krankenhaus-dernbach.de/medizinische-bereiche/medizinische-fachabteilungen/medizinische-klinik-i
Principal Investigator
- Address:
- Universität Duisburg-EssenProfessor Dr. med. Frank BreuckmannHufelandstr. 2745127 EssenGermany
- Telephone:
- +49 2602 684-225
- Fax:
- +49 2602 684-227
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.krankenhaus-dernbach.de/medizinische-bereiche/medizinische-fachabteilungen/medizinische-klinik-i
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Arbeitsgemeinschaft Intensivmedizin (AIM) ArnsbergApothekerstrasse 2759755 ArnsbergGermany
- Telephone:
- +49 2932 700 105
- Fax:
- +49 2932 700 139
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://aim-arnsberg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-EssenRobert-Koch-Str. 9-1145147 EssenGermany
- Telephone:
- +49-201-7233637
- Fax:
- +49-201-7235837
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-09-21
- Ethics committee number:
- 19-8966-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-03-27
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Yes, all after prior personal review by us (Study Board). Interested parties can contact the study board (see below). Extent and scope will then be determined in a personal interview.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Simulation-based randomized trial of medical emergency cognitive aids. Sellmann T, Alchab S, Wetzchewald D, Meyer J, Rassaf T, Thal SC, Burisch C, Marsch S, Breuckmann F. Scand J Trauma Resusc Emerg Med. 2022 Jul 11;30(1):45. doi: 10.1186/s13049-022-01028-y. PMID: 35820939
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry