A randomised controlled trial of the effectiveness of a paediatric head injury co-ordinator nurse in reducing subsequent contact with health care professionals
| ISRCTN | ISRCTN12357672 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12357672 |
| Secondary identifying numbers | N0544139664 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 30/03/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Deborah White
Scientific
Scientific
Box No 7
Paediatric Intensive Care Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 217613 |
|---|---|
| deborah.white@addenbrookes.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Approximately 15-20% of so called 'mild' head injured children develop morbidities that necessitate further healthcare interventions. 1000 children are seen in Accident and Emergency (A&E) at Addenbrooke's with 'mild head injury' per year. Our study will be conducted in two parts. On discharge from the accident and emergency department following a minor head injury, the carers of children are given an information card containing information on expected side effects from the accident. This card is standard care and a requirement following NICE (National Institute of Clinical Excellence) guidelines. Stage 1: A population-based observational study in order to calculate a sample size for stage 2. Following informed consent, we will contact families 2 weeks following their child's A&E attendance and ask a series of questions around their child's recovery to ascertain how long their child had off school and if the family had to seek further help or advice from the GP or A&E department. This stage of the work will be used as a pilot study and the results obtained will allow us to calculate the sample size needed for stage 2, a randomised controlled trial. The information card will be adapted to include the following name and contact number 'Deborah White, Paediatric Research Nurse - 01223 245151 bleep 151-879'. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Not Applicable: Service delivery |
| Intervention | Following informed consent, families will be randomised to one of two groups. The first group will be contacted 1 week following injury to ascertain the progress of the child and offer advice to the family about dealing with the expected symptoms following a head injury. Both groups 1 and 2 will be contacted 2 weeks following the injury as in stage 1. |
| Intervention type | Other |
| Primary outcome measure | The two groups would then be compared to see if the number of visits to A&E or to the GP were any different across the two groups. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 04/03/2003 |
| Completion date | 03/03/2007 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 04/03/2003 |
| Date of final enrolment | 03/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box No 7
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK)
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 |
