Clinical and cost effectiveness of different emergency department healthcare professionals in soft tissue management
| ISRCTN | ISRCTN70891354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70891354 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/08/2007
- Registration date
- 07/10/2010
- Last edited
- 01/11/2013
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Carey McClellan
Scientific
Scientific
The Academic Department of Emergency Care
The Adult Emergency Department
University Hospital Bristol NHS Foundation Trusts
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)7846 410489 |
|---|---|
| carey2.mcclellan@uwe.ac.uk |
Study information
| Study design | Pragmatic multicentre three-arm blinded randomised controlled trial of equivalence |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Clinical and cost effectiveness of different emergency department healthcare professionals in soft tissue management: a randomised trial |
| Study acronym | MISTi Trial - Management In Soft Tissue injury Trial |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2006 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 17 Years |
| Sex | Both |
| Target number of participants | 900 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Academic Department of Emergency Care,
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
University of the West of England (UK)
University/education
University/education
Faculty of Health and Social Care
Glenside Campus
Blackberry Hill
Stapleton
Bristol
BS16 1DD
England
United Kingdom
| deb.joy@uwe.ac.uk | |
| Website | http:/www.uwe.ac.uk |
"ROR" |
https://ror.org/02nwg5t34 |
Funders
Funder type
University/education
University of the West of England (UK) - funded as part of a PhD bursary
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of pilot study | 01/05/2006 | Yes | No | |
| Results article | results | 08/11/2012 | Yes | No | |
| Results article | results | 03/01/2013 | Yes | No |
