- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260386
Assessing a New Proforma for Maternal Cardiac Arrest
A Study to Assess the Utility of a New Proforma in Simulated Clinical Scenarios of Maternal Cardiac Arrest
During the Multidisciplinary Obstetric and Midwifery Simulation (MOMS) course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link.
The delegates observing the cardiac arrest scenario will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. Delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of standardised proformas can improve the quality and completeness of data collection in healthcare settings. In a previous study we have found that medical records examined by the Confidential Enquiries into Maternal Deaths (CEMD) 2009-2012 were variable in their quality, often poor and in need of improvement. In view of this, we have developed a proforma to assist the quality of record-keeping during maternal cardiac arrest, using a modified Delphi process amongst a multidisciplinary group of CEMD assessors. The present application is for a study evaluating clinicians' views of this proforma and its usefulness in a simulator setting (as maternal cardiac arrest is so rare, evaluation in actual cases would be a very lengthy and expensive venture; such a study would have to be multicentre and would require a preliminary evaluation such as the one being proposed here, anyway).
One hundred participants will take part in the study during the routine Multidisciplinary Obstetric and Midwifery Simulation (MOMS) training course at the Chelsea and Westminster Hospital. During the course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link. A brief information sheet and explanation will be provided before consent is sought to take part in the study.
During the cardiac arrest scenario, the delegates observing will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. One or more team members would routinely be given the role of 'scribe', recording events as they occur. Delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma. All of the data will be collected pseudo-anonymously.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Greater London
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London, Greater London, United Kingdom, SW10 9NH
- Chelsea and Westminster Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Delegates taking part in the routine Multidisciplinary Obstetric and Midwifery Simulation training course at the Chelsea and Westminster Hospital.
Exclusion Criteria:
- Unwillingness to participate and provide written consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Staff receiving the MOMS training
Delegates taking part in the routine Multidisciplinary Obstetric and Midwifery Simulation (MOMS) training course at the Chelsea and Westminster Hospital.
|
During the cardiac arrest scenario, the delegates observing will be asked to refer to the maternal cardiac arrest proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. One or more team members would routinely be given the role of 'scribe', recording events as they occur. The proforma is accompanied by explanatory notes on how to use it. Delegates (observers plus scribes) will then be asked to complete a questionnaire, seeking their opinions on the usefulness of the proforma. Questionnaires will be linked to the written consent forms by a participant ID number. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Views of the multidisciplinary team members on the utility of the proforma in simulated clinical scenarios of maternal cardiac arrest.
Time Frame: Each participant is expected to be in the study for one day.
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The primary outcome is the views of multidisciplinary team members on the usefulness of the maternal cardiac arrest proforma.
Researchers will not be assessing the completion of the proforma so they will not be collecting these at the end of the simulation.
They have chosen to test the proforma during simulated maternal cardiac arrest, as the best practicable surrogate for an actual maternal cardiac arrest.
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Each participant is expected to be in the study for one day.
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Collaborators and Investigators
Investigators
- Principal Investigator: Eleanor Roderick, BMBCh BA, Chelsea And Westminster Hospital NHS Foundation Trust
Publications and helpful links
General Publications
- Patel A, Rockall A, Guthrie A, Gleeson F, Worthy S, Grubnic S, Burling D, Allen C, Padhani A, Carey B, Cavanagh P, Peake MD, Brown G. Can the completeness of radiological cancer staging reports be improved using proforma reporting? A prospective multicentre non-blinded interventional study across 21 centres in the UK. BMJ Open. 2018 Oct 2;8(10):e018499. doi: 10.1136/bmjopen-2017-018499.
- Green AR, Hoyle J, Knight MK, Yentis SM. Documentation of maternal cardiac arrest in clinical case notes. International Journal of Obstetric Anesthesia 2017; 31 Suppl 1: S41.
- A proforma for recording maternal cardiac arrest, R Soysa, MK Knight, SM Yentis. International Journal of Obstetric Anesthesia 2019 (in press).
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C&W19/004
- 264325 (Other Identifier: Integrated Research Application System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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