Assessing a New Proforma for Maternal Cardiac Arrest

NCT ID: NCT04260386

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-23

Study Completion Date

2020-03-11

Brief Summary

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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

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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.

Conditions

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Maternal Death Cardiac Arrest Heart Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Non-Interventional

Intervention Type OTHER

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.

Interventions

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Non-Interventional

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eleanor Roderick, BMBCh BA

Role: PRINCIPAL_INVESTIGATOR

Chelsea and Westminster NHS Foundation Trust

Locations

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Chelsea and Westminster Hospital

London, Greater London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 30282676 (View on PubMed)

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.

Reference Type BACKGROUND

A proforma for recording maternal cardiac arrest, R Soysa, MK Knight, SM Yentis. International Journal of Obstetric Anesthesia 2019 (in press).

Reference Type BACKGROUND

Other Identifiers

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264325

Identifier Type: OTHER

Identifier Source: secondary_id

C&W19/004

Identifier Type: -

Identifier Source: org_study_id

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