Condition category
Pregnancy and Childbirth
Date applied
29/08/2006
Date assigned
25/09/2006
Last edited
07/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bryony Strachan

ORCID ID

Contact details

St Michael's Hospital
Southwell Street
Bristol
BS2 8UG
United Kingdom
+44 (0) 117 9285594
bryony.strachan@ubht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0270030

Study information

Scientific title

Acronym

SaFE study

Study hypothesis

The use of mock drills in simulation centres and labour wards (fire drills) has increased in response to issues of patient safety and the Clinical Negligence Scheme for Trusts (CNST) requirements. These provide opportunities for staff to practise emergency obstetric scenarios. However, there has been little evaluation of the effects of such training on individuals or obstetric teams. The Department of Health has funded this work, to establish proof of principle of the effect of individual and team drill training on the ability of labour ward staff to manage acute obstetric emergencies. The study evaluates training involving simulation centre and local in-house labour ward drills, so that future policies and studies can be based on the most promising methods.

The aim of this study is to evaluate the effect of individual and team drill for the management of acute obstetric emergencies. The specific research questions are:

1. Primary questions
a. Does the use of a high fidelity setting improve clinical skills in obstetric emergencies?
b. Does including team training in emergency drills improve clinical skills in dealing with obstetrics emergencies?

2. Secondary questions
a. Does team training in obstetric emergency drills improve team working?
b. Does the use of a high fidelity setting improve team working in obstetric emergencies?
c. Does team training in emergency drills improve knowledge in obstetric emergencies?
d. Does the use of a high fidelity setting improve knowledge in obstetric emergencies?

Ethics approval

Southwest Devon Medical Research Ethics Committee (reference number: 04/Q2103/68), approval gained on September 2004.

Study design

Phase II exploratory trial within the format of a factorial 2 x 2 randomised trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute obstetric emergencies

Intervention

Phase II exploratory trial of two aspects of the training intervention, high versus low fidelity and team training versus no team training, will be assessed within the format of a factorial 2 x 2 randomised trial.

The participants will be randomly allocated to one of the four training interventions.
Group A1: One day obstetric emergency training course. This will be within the low fidelity setting in the local participating hospitals and will exclude specific team training.
Group B1: One day obstetric emergency training course. This will be within the high fidelity setting of the Bristol Medical Simulation Centre and will exclude specific team training.
Group A2: Two day obstetric emergency training course. This will be within the low fidelity setting of the local participating hospitals and will include specific team training.
Group B2: Two day obstetric emergency training course. This will be within the high fidelity setting of the Bristol Medical Simulation Centre and will include specific team training.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

1. Global rating scores of individual clinical skills
2. Time taken to execute procedures
3. Number of actions, omissions and inappropriate actions

Secondary outcome measures

1. Knowledge assessed by a multiple choice questionnaire
2. Applied delivery force in shoulder dystocia skill station
3. Communication - as assessed by a content analysis of a sub sample of skill stations
4. Global rating scores of teamwork behaviours on a sub sample of skill stations

Overall trial start date

01/11/2004

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All hospital and community midwives and obstetric medical staff (junior and senior) who provide care to mothers and babies are eligible to enter the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144

Participant exclusion criteria

Staff who have attended addition accredited training course in the management of obstetric emergencies (Advanced Life Support in Obstetrics [ALSO], Managing Obstetric Emergencies and Trauma [MOET], South West Obstetric Emergency Course) within the past 12 months will be excluded from the study, and also:
1. Staff who have taken part in the Simulation and Fire drill Evaluation study (SaFE) pilot study
2. Staff involved in the delivery of the training interventions
3. Local staff involved in assisting the research team
4. Staff currently on maternity leave or long term sick leave

Recruitment start date

01/11/2004

Recruitment end date

01/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Michael's Hospital
Bristol
BS2 8UG
United Kingdom

Sponsor information

Organisation

United Bristol Healthcare Trust (UK)

Sponsor details

Research and Effectiveness Department
Marlborough Street
Bristol
BS1 3NU
United Kingdom
+44 (0) 117 923 0000
maria.palmer@ubht.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The trial is funded by Policy Research Programme of the Department of Health as part of the Patient Safety Research Portfolio (PSRP) (reference number: 0270030).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18310377

Publication citations

  1. Results

    Ellis D, Crofts JF, Hunt LP, Read M, Fox R, James M, Hospital, simulation center, and teamwork training for eclampsia management: a randomized controlled trial., Obstet Gynecol, 2008, 111, 3, 723-731, doi: 10.1097/AOG.0b013e3181637a82.

Additional files

Editorial Notes