Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000629639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
12/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alternative Referrals for ACC Injuries
Scientific title
A randomised controlled trial of GPSI versus Usual Care in the treatment of general practice patients with musculoskeletal injuries.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal injuries 757 0
Condition category
Condition code
Musculoskeletal 833 833 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Advanced injury care by a GP with a Special Interest (GPSI) and advanced training in musculoskeletal injury care. Duration of the intervention is until resolution of the injury or up to 6 months from trial entry.
Intervention code [1] 541 0
Other interventions
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1070 0
Time from referral to a patient's functional recovery.
Timepoint [1] 1070 0
Secondary outcome [1] 1983 0
Waiting time to first specialist orthopaedic assessment
Timepoint [1] 1983 0
Secondary outcome [2] 1984 0
Patients satisfaction with care
Timepoint [2] 1984 0
Secondary outcome [3] 1985 0
Time off work
Timepoint [3] 1985 0

Eligibility
Key inclusion criteria
1.Adult Dunedin residents affected by an orthopaedic injury covered by ACC, who would normally be referred by their general practitioners to an orthopaedic surgeon where the referral is not Immediate or Urgent as outlined in the National Access Criteria for First Assessment, February 2001.2. Patients who consent to participate in the study and agree to be randomised to either GPSI or normal care.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients unable or unwilling to consent to participate in the study on their own behalf. 2. Registered patients who normally receive all their general practice care from the four Dunedin GPSIs. 3.Dunedin residents affected by an injury covered by ACC, where the referral to an orthopaedic surgeon is Immediate or Urgent as outlined in the National Access Criteria for First Assessment, February 2001. 4. Dunedin residents affected by an injury covered by ACC, whose care would normally be entirely managed by their general practitioner or another primary care provider.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generation using computer software SPSS - without blocking or stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 210 0
New Zealand
State/province [1] 210 0

Funding & Sponsors
Funding source category [1] 921 0
Charities/Societies/Foundations
Name [1] 921 0
South Link Health Inc
Country [1] 921 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
South Link health Inc
Address
Country
New Zealand
Secondary sponsor category [1] 779 0
Commercial sector/Industry
Name [1] 779 0
Accident Compensation Corporation
Address [1] 779 0
Country [1] 779 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Annually in Dunedin ACC covers care for about 1500 patients with musculoskeletal injuries. These patients are currently referred to the orthopaedic surgeon for assessment, investigation, and/or surgical treatment. About 33% ultimately have orthopaedic surgery. The remaining 67% receive care that could be delivered by GPs with access to appropriate resources (e.g. MRI and CT scans) and training in advanced primary care procedures (e.g. joint injection). Waiting times from referral by their GP to first assessment by orthopaedic surgeons currently average 13 weeks. Earlier assessment and/or intervention by a GP with a special interest in orthopaedics (GPSI) may reduce the time patients wait until they have definitive treatment and thereby reduce their time to functional recovery. Alternatively, GPSI care may simply delay needed orthopaedic surgical intervention. The GPSI programme is new to New Zealand. We propose to study its introduction in Dunedin. The study will not alter the processes already established to manage appropriate care for patients with orthopaedic injuries EXCEPT by randomising the first 110 eligible patients to Usual Care or GPSI care. Most study data will come from data routinely collected on ACC forms and in patient records.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35320 0
Address 35320 0
Country 35320 0
Phone 35320 0
Fax 35320 0
Email 35320 0
Contact person for public queries
Name 9730 0
Professor Murray Tilyard
Address 9730 0
South Link Health Inc
Level 9
10 George St
PO Box 6032
Dunedin
Country 9730 0
New Zealand
Phone 9730 0
+64 3 4772628
Fax 9730 0
Email 9730 0
[email protected]
Contact person for scientific queries
Name 658 0
Associate Professor Susan Dovey
Address 658 0
Department of General Practice
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 658 0
New Zealand
Phone 658 0
+64 3 4794135
Fax 658 0
Email 658 0
[email protected]

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.