Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHC21007
Study information
Scientific title
Acronym
Study hypothesis
What are the economic, human and social effects of implementing a trauma nurse co-ordinator?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Musculoskeletal injury
Intervention
Eligible patients randomised to 1. TNC care or 2. No TNC care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
14/10/1996
Overall trial end date
14/10/1998
Reason abandoned
Eligibility
Participant 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%.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
1080
Participant 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
Recruitment start date
14/10/1996
Recruitment end date
14/10/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Salford Royal Hospitals NHS Trust
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive North West (UK)
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
Results - basic reporting
Publication summary