Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/08/2007
Date assigned
07/10/2010
Last edited
01/11/2013
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

Dr Carey McClellan

ORCID ID

Contact details

The Academic Department of Emergency Care
The Adult Emergency Department
University Hospital Bristol NHS Foundation Trusts
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
+44 (0)7846 410489
carey2.mcclellan@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Clinical and cost effectiveness of different emergency department healthcare professionals in soft tissue management: a randomised trial

Acronym

MISTi Trial - Management In Soft Tissue injury Trial

Study hypothesis

This research is a trial of equivalence and investigates two null hypotheses:
1. The clinical outcome of adult patients presenting to the Emergency Department (ED) with a soft tissue injury (STI) is different between healthcare professionals
2. A doctor, Emergency Nurse Practitioner (ENP) and Extended Scope Physiotherapist (ESP) are not equally cost-effective in treating ED patients with soft tissue injuries

Ethics approval

Approved by:
1. The Salisbury and South Wiltshire Ethics Committee, obtained on the 4th May 2006 (ref: 06/Q2008/10)
2. The Faculty of Health and Social Care Ethics Committee at the University of the West of England, obtained on the 10th July 2006 (ref: HSC/06/07/57)

Study design

Pragmatic multicentre three-arm blinded randomised controlled trial of equivalence

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute peripheral musculoskeletal soft tissue injury

Intervention

Active control: Doctors (of all grades)
Intervention under investigation: Extended Scope Physiotherapist (ESP) and Emergency Nurse Practitioners (ENP). The intervention is the care provided by ESPs and ENPs compared to routine treatment by Doctors.

The patients are being followed up at 14 days and 8 weeks post treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary aspect of the study will evaluate the clinical outcome of STIs following attendance at an emergency department, and the impact on quality of life. This will be done at baseline, and at 2 and 8 weeks using telephone interviews. The trial is powered to detect differences at the 8-week follow up.

Two validated and reliable functional outcome measures will be use in the trial: the Lower Extremity Functional Scale (LEFS) and the Quick Disabilities of the Arm, Shoulder and Hand ( Quick DASH) questionnaire. Quality of life will be measured using the Short Form-12 Health Survey Questionnaire, Version 2 (SF-12v2).

Secondary outcome measures

The secondary aspect of the study will be an economic analysis identifying, quantifying and comparing the costs of both the emergency department visit and subsequent costs to the individual, NHS and society. Process measures associated with the three different types of healthcare practitioner (e.g. number of patients treated per hour and referral rate) will also be considered.

Overall trial start date

01/10/2006

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (17 years or older), male or female
2. Patients presenting to an ED with a peripheral soft tissue injury with no immediately apparent fracture and is eligible for management by any of the three professional groups
2. Patients who consent to the study
3. All three practitioners working concurrently when the patient is admitted to the emergency department, to enable randomisation
5. A traumatic injury
6. Soft tissue injury less than 72 hours old
7. Patients will be included if they have minor grazes or wounds that require no treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

900

Participant exclusion criteria

1. Systemic disease
2. Recent surgery
3. Previous ongoing injury to extremity
4. Intoxicated patients
5. Patients unable to give informed consent (e.g. dementia)
6. Open wounds/wounds (patient will be included if minor and insignificant)
7. Major deformities
8. Patients requiring opiate analgesia
9. Systemic disease (e.g. rheumatoid arthritis)
10. Healing fracture (less than 3 months)
11. Recent soft tissue injury
12. Head injuries (patient will be included if minor and insignificant)
13. Chest/rib injuries (patient will be included if minor and insignificant)
14. Neurovascular deficits
15. Less than 17 years of age
16. Obvious associated fractures
17. Patients who attend the ED when there is no ESP, ENP, doctor service running concurrently
18. Prisoners

Recruitment start date

01/10/2006

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Academic Department of Emergency Care,
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University of the West of England (UK)

Sponsor details

Faculty of Health and Social Care
Glenside Campus
Blackberry Hill
Stapleton
Bristol
BS16 1DD
United Kingdom
deb.joy@uwe.ac.uk

Sponsor type

University/education

Website

http:/www.uwe.ac.uk

Funders

Funder type

University/education

Funder name

University of the West of England (UK) - funded as part of a PhD bursary

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

1. 2006 results of pilot study in http://www.ncbi.nlm.nih.gov/pubmed/16627842
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23144256
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23293239

Publication citations

  1. Results of pilot study

    McClellan CM, Greenwood R, Benger JR, Effect of an extended scope physiotherapy service on patient satisfaction and the outcome of soft tissue injuries in an adult emergency department., Emerg Med J, 2006, 23, 5, 384-387, doi: 10.1136/emj.2005.029231.

  2. Results

    McClellan CM, Cramp F, Powell J, Benger JR, A randomised trial comparing the clinical effectiveness of different emergency department healthcare professionals in soft tissue injury management., BMJ Open, 2012, 2, 6, doi: 10.1136/bmjopen-2012-001092.

  3. Results

    McClellan CM, Cramp F, Powell J, Benger JR, A randomised trial comparing the cost effectiveness of different emergency department healthcare professionals in soft tissue injury management., BMJ Open, 2013, 3, 1, doi: 10.1136/bmjopen-2012-001116.

Additional files

Editorial Notes