A prospective randomised controlled trial (RCT) to assess the effect of implementing a trauma nurse co-ordinator (TNC)
ISRCTN | ISRCTN76476654 |
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DOI | https://doi.org/10.1186/ISRCTN76476654 |
Secondary identifying numbers | RHC21007 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 31/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Mr Peter Driscoll
Scientific
Scientific
Salford Royal Hospitals NHS Trust
Department of Emergency Medicine
Stott Lane
Salford
M6 8HD
United Kingdom
Phone | +44 (0)161 787 5372 |
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abc@email.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Other |
Scientific title | A prospective randomised controlled trial (RCT) to assess the effect of implementing a trauma nurse co-ordinator (TNC) |
Study objectives | What are the economic, human and social effects of implementing a trauma nurse co-ordinator? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Musculoskeletal injury |
Intervention | Eligible patients randomised to 1. TNC care or 2. No TNC care |
Intervention type | Other |
Primary outcome measure | 1. Length of stay - measured in days from admission to discharge. 2. Mortality/Survival - this will be assessed on discharge using the TRISS methodology. The latter is the probability of survival derived by an internationally recognised measure and will be based on the Major Trauma Outcome Study (MTOS) database. 3. Cost - this will quantify the current costs and those incurred in introducing a TNC into a hospital and his/her direct involvement in patient care. 4. Quality of Life - this will be measured using the validated SF36 questionnaire. This form measures health in eight multi-item dimensions, covering functional states, well being and overall evaluation of health. This form has been used, under license, by the Orthopaedic Department in the hospital sine 1992. 5. Satisfaction - this will be measured in both patients and carers using a specially designed questionnaire and will be measured at specific time intervals after discharge. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 14/10/1996 |
Completion date | 14/10/1998 |
Eligibility
Participant type(s) | Patient |
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Age group | Other |
Sex | Both |
Target number of participants | 1080 |
Key inclusion criteria | During a one month mapping exercise, 42% of surviving patients had a hospital stay 3 days or less. Therefore 1080 patients will be required to detect a difference of 10% between the study groups in the proportion of the patients discharged within 3 days of admission for a study power of 90% at the 5% two sided significance level. This is assuming a 5% death rate and a recruitment rate of 90%. |
Key exclusion criteria | 1. Refusal to participate 2. Missed patients (information not collected by research assistant) 3. Fractured neck of femur 4. Died in A&E 5. Transfer out of hospital from A&E |
Date of first enrolment | 14/10/1996 |
Date of final enrolment | 14/10/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Salford Royal Hospitals NHS Trust
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive North West (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Editorial Notes
31/10/2019: No publications found. All search options exhausted.