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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
-
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.
-
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.