Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000607471
Ethics application status
Approved
Date submitted
22/11/2007
Date registered
26/11/2007
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of different models of providing physiotherapy care for people with simple musculoskeletal injuries presenting to Emergency Department
Scientific title
Does primary contact physiotherapy for people presenting to the Emergency Department with simple peripheral musculoskeletal injuries result in reduced patient length of stay in the Emergency Department compared with secondary contact physiotherapy?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral musculoskeletal injuries 2572 0
Condition category
Condition code
Musculoskeletal 2681 2681 0 0
Other muscular and skeletal disorders
Injuries and Accidents 2682 2682 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary contact physiotherapy assessment and management of simple peripheral musculoskeletal injuries presenting to Emergency Department. Primary contact physiotherapy is when the patient is referred directly to the physiotherapist after triage. The intervention comprises a single episode of care expected to last less than 3 hours. The complete duration of the project is expected to be 18 months.
Intervention code [1] 2307 0
Treatment: Other
Comparator / control treatment
Secondary contact physiotherapy assessment and management of simple peripheral musculoskeletal injuries presenting to Emergency Department. Secondary contact physiotherapy is when the patient is referred to the physiotherapist after first being assessed and managed as by a doctor. The intervention comprises a single episode of care expected to last less than 3 hours.
Control group
Active

Outcomes
Primary outcome [1] 3584 0
Patient length of stay in Emergency Department (defined as difference between arrival time and departure time)
Timepoint [1] 3584 0
At the time of presentation at Emergency Department
Secondary outcome [1] 6001 0
Patient satisfaction questionnaire
Timepoint [1] 6001 0
At the time of presentation at Emergency Department
Secondary outcome [2] 6002 0
Staff satisfaction questionnaire
Timepoint [2] 6002 0
At the end of the project
Secondary outcome [3] 6003 0
Number of referrals to radiology
Timepoint [3] 6003 0
At the time of presentation at Emergency Department
Secondary outcome [4] 6004 0
Patient re-presentations to Emergency Department
Timepoint [4] 6004 0
In the 4 weeks following initial presentation
Secondary outcome [5] 6005 0
Treatment time (defined as the difference between assessment time and departure time)
Timepoint [5] 6005 0
At the time of presentation at Emergency Department
Secondary outcome [6] 6006 0
Waiting time (defined as the difference between arrival time and time of initial medical or physiotherapy assessment)
Timepoint [6] 6006 0
At the tiime of presentation to Emergency Department

Eligibility
Key inclusion criteria
1. Present to Emergency Department at Eastern Health at Box Hill, Maroondah or Angliss Hospitals
2. Simple peripheral musculoskeletal injury (e.g. ankle sprain, knee injury, shoulder strain, elow or wrist injury)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The injury results from significant trauma such as motor vehicle accident, or a fall from a height > 1 m
2. Red flags indicating serious pathology are identified
3. Patient presents with any of the following: open fracture, unreduced dislocation, open wounds, loss of consciousness, shortness of breath with chest pain and left arm pain, dizziness or headache, complex co-morbidities, pregnancy, neck pain, or low back pain

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 335 0
3128
Recruitment postcode(s) [2] 336 0
3156
Recruitment postcode(s) [3] 337 0
3135
Recruitment postcode(s) [4] 338 0
3131

Funding & Sponsors
Funding source category [1] 2818 0
Self funded/Unfunded
Name [1] 2818 0
Country [1] 2818 0
Primary sponsor type
Hospital
Name
Eastern Health
Address
Clive Ward Centre
16 Arnold Street
Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 2544 0
University
Name [1] 2544 0
La Trobe University
Address [1] 2544 0
La Trobe University
VIC 3086
Country [1] 2544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4743 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 4743 0
Ethics committee country [1] 4743 0
Australia
Date submitted for ethics approval [1] 4743 0
26/11/2007
Approval date [1] 4743 0
13/12/2007
Ethics approval number [1] 4743 0
E53/0708

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28205 0
Address 28205 0
Country 28205 0
Phone 28205 0
Fax 28205 0
Email 28205 0
Contact person for public queries
Name 11362 0
Professor Nicholas Taylor
Address 11362 0
School of Physiotherapy
La Trobe University
VIC 3086
Country 11362 0
Australia
Phone 11362 0
+61 3 98812464
Fax 11362 0
Email 11362 0
N.Taylor@latrobe.edu.au
Contact person for scientific queries
Name 2290 0
Professor Nicholas Taylor
Address 2290 0
School of Physiotherapy
La Trobe University
VIC 3086
Country 2290 0
Australia
Phone 2290 0
+61 3 98812464
Fax 2290 0
Email 2290 0
N.Taylor@latrobe.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.