A prospective randomised controlled trial (RCT) to assess the effect of implementing a trauma nurse co-ordinator (TNC)

ISRCTN ISRCTN76476654
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

Salford Royal Hospitals NHS Trust
Department of Emergency Medicine
Stott Lane
Salford
M6 8HD
United Kingdom

Phone +44 (0)161 787 5372
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific titleA prospective randomised controlled trial (RCT) to assess the effect of implementing a trauma nurse co-ordinator (TNC)
Study objectivesWhat 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) studiedMusculoskeletal injury
InterventionEligible patients randomised to 1. TNC care or 2. No TNC care
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date14/10/1996
Completion date14/10/1998

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants1080
Key inclusion criteriaDuring 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 criteria1. 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 enrolment14/10/1996
Date of final enrolment14/10/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Salford Royal Hospitals NHS Trust
Salford
M6 8HD
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

31/10/2019: No publications found. All search options exhausted.