NCT04260386

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

February 5, 2020

Last Update Submit

August 5, 2021

Conditions

Keywords

Maternal Cardiac ArrestClinical Scenarios Simulation

Outcome Measures

Primary Outcomes (1)

  • Views of the multidisciplinary team members on the utility of the proforma in simulated clinical scenarios of maternal cardiac arrest.

    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.

    Each participant is expected to be in the study for one day.

Study Arms (1)

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.

Other: Non-Interventional

Interventions

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.

Staff receiving the MOMS training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Delegates taking part in the routine Multidisciplinary Obstetric and Midwifery Simulation training course at the Chelsea and Westminster Hospital.

You may not qualify if:

  • Unwillingness to participate and provide written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hospital

London, Greater London, SW10 9NH, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 30282676BACKGROUND
  • 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.

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

    BACKGROUND

MeSH Terms

Conditions

Maternal DeathHeart Arrest

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Eleanor Roderick, BMBCh BA

    Chelsea and Westminster NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

August 23, 2019

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations