Assessing a New Proforma for Maternal Cardiac Arrest

Sponsor
Chelsea and Westminster NHS Foundation Trust (Other)
Overall Status
Terminated
CT.gov ID
NCT04260386
Collaborator
(none)
39
1
6.6
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-Interventional

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 Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
A Study to Assess the Utility of a New Proforma in Simulated Clinical Scenarios of Maternal Cardiac Arrest
Actual Study Start Date :
Aug 23, 2019
Actual Primary Completion Date :
Mar 11, 2020
Actual Study Completion Date :
Mar 11, 2020

Arms and Interventions

Arm 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Views of the multidisciplinary team members on the utility of the proforma in simulated clinical scenarios of maternal cardiac arrest. [Each participant is expected to be in the study for one day.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chelsea and Westminster Hospital London Greater London United Kingdom SW10 9NH

Sponsors and Collaborators

  • Chelsea and Westminster NHS Foundation Trust

Investigators

  • Principal Investigator: Eleanor Roderick, BMBCh BA, Chelsea and Westminster Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04260386
Other Study ID Numbers:
  • C&W19/004
  • 264325
First Posted:
Feb 7, 2020
Last Update Posted:
Aug 6, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chelsea and Westminster NHS Foundation Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2021