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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18310377
Publication citations
-
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.