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
Protocol serial number	RHC21007
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive North West (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	14/10/1998

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Salford Royal Hospitals NHS Trust

Salford
M6 8HD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

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