Clinical trial NCT04260386: Assessing a New Proforma for Maternal Cardiac Arrest
Official title: A Study to Assess the Utility of a New Proforma in Simulated Clinical Scenarios of Maternal Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Maternal Death
Cardiac Arrest
Heart Arrest
Keywords: Maternal Cardiac Arrest
Clinical Scenarios Simulation
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Views of the multidisciplinary team members on the utility of the proforma in simulated clinical scenarios of maternal cardiac arrest.
timeFrame: Each participant is expected to be in the study for one day.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
state: Greater London
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Eleanor Roderick, BMBCh BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: A proforma for recording maternal cardiac arrest, R Soysa, MK Knight, SM Yentis. International Journal of Obstetric Anesthesia 2019 (in press).