Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter Driscoll

ORCID ID

Contact details

Salford Royal Hospitals NHS Trust
Department of Emergency Medicine
Stott Lane
Salford
M6 8HD
United Kingdom
+44 (0)161 787 5372

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes