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 | https://doi.org/10.1186/ISRCTN67906788 |
| Secondary identifying numbers | 0270030 |
- Submission date
- 29/08/2006
- Registration date
- 25/09/2006
- Last edited
- 07/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bryony Strachan
Scientific
Scientific
St Michael's Hospital
Southwell Street
Bristol
BS2 8UG
United Kingdom
| Phone | +44 (0) 117 9285594 |
|---|---|
| bryony.strachan@ubht.nhs.uk |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SaFE study |
| Study objectives | 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(s) | Southwest Devon Medical Research Ethics Committee (reference number: 04/Q2103/68), approval gained on September 2004. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2004 |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 144 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Michael's Hospital
Bristol
BS2 8UG
United Kingdom
BS2 8UG
United Kingdom
Sponsor information
United Bristol Healthcare Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Effectiveness Department
Marlborough Street
Bristol
BS1 3NU
England
United Kingdom
| Phone | +44 (0) 117 923 0000 |
|---|---|
| maria.palmer@ubht.nhs.uk | |
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Government
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).
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/03/2008 | Yes | No |
