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Proof of principle study of the effect of individual and team drill on the ability of labour ward staff to manage acute obstetric emergencies
ISRCTN ISRCTN67906788
DOI 10.1186/ISRCTN67906788
ClinicalTrials.gov identifier
EudraCT number
Public title Proof of principle study of the effect of individual and team drill on the ability of labour ward staff to manage acute obstetric emergencies
Scientific title
Acronym SaFE study
Serial number at source 0270030
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?
Lay summary
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.
Countries of recruitment United Kingdom
Disease/condition/study domain Acute obstetric emergencies
Participants - 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.
Participants - 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
Anticipated start date 01/11/2004
Anticipated end date 01/11/2006
Status of trial Completed
Patient information material
Target number of participants 144
Interventions 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.
Primary outcome measure(s) 1. Global rating scores of individual clinical skills
2. Time taken to execute procedures
3. Number of actions, omissions and inappropriate actions
Secondary outcome measure(s) 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
Sources of funding 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).
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18310377
Contact name Dr  Bryony  Strachan
  Address St Michael's Hospital
Southwell Street
  City/town Bristol
  Zip/Postcode BS2 8UG
  Country United Kingdom
  Tel +44 (0) 117 9285594
  Email bryony.strachan@ubht.nhs.uk
Sponsor United Bristol Healthcare Trust (UK)
  Address Research and Effectiveness Department
Marlborough Street
  City/town Bristol
  Zip/Postcode BS1 3NU
  Country United Kingdom
  Tel +44 (0) 117 923 0000
  Email maria.palmer@ubht.nhs.uk
Date applied 29/08/2006
Last edited 07/03/2008
Date ISRCTN assigned 25/09/2006
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