Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001211954p
Ethics application status
Submitted, not yet approved
Date submitted
11/09/2020
Date registered
16/11/2020
Date last updated
16/11/2020
Date data sharing statement initially provided
16/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the impact on in-hospital orthopaedic waitlists after the introduction of subsidised access to out-of-hospital allied health services for patients with chronic musculoskeletal conditions
Scientific title
Evaluating the impact on in-hospital orthopaedic waitlists after the introduction of subsidised access to out-of-hospital allied health services for patients with chronic musculoskeletal conditions
Secondary ID [1] 302286 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic musculoskeletal conditions 319030 0
health service delivery 319031 0
Condition category
Condition code
Musculoskeletal 316983 316983 0 0
Other muscular and skeletal disorders
Public Health 316984 316984 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This activity aims to test the market for what patients are willing to pay for existing allied health services, and to determine if cost is a barrier to access. General Practice Medical Centres will be randomised to one of four subsidy schemes. folowing on from an advanced physiotherapy assessment, participating patients can then access existing allied health services, as per the subsidy arm allocated to their General Practice Medical Centre.

Subsidy A- Control arm- Allied Health Market rate (standard) fees + (MBS- GPMP/TCA- 5 subsidised visits)
Participant to fund additional costs at market rate
Subsidy B- Participants to receive additional 5 subsidised sessions (equivalent of 10 GPMP/TCA sessions)
Participant to fund additional costs at market rate
Subsidy C- As per subsidy B- Participants receive equivalent of 10 GPMP/TCA sessions
Participants contribute $10-20 per session toward market rate
Subsidy D - Participants receive equivalent of 10 GPMP/TCA sessions
Participants to receive full gap payment (no out of pocket expenses)

services will only be subsidsed for a 2 year period. it is advised that participants commence their individual treatment plan ASAP, but certainly within the 2 year period of the subsidy.
Intervention code [1] 318571 0
Treatment: Other
Comparator / control treatment
Subsidy A- Control arm- Allied Health Market rate (standard) fees + (MBS- GPMP/TCA- 5 subsidised visits)
Participant to fund additional costs at market rate
Control group
Active

Outcomes
Primary outcome [1] 325092 0
Outcome is discharge from care, or no discharge from care

Successful outcome is: discharge from care (from orthopaedics department)
if patients have completed their tailored treatment plan (8-10 sessions) and assessed post treatment plan to no longer need further services, they will be discharged from Cairns Orthopaedic department (including the physiotherapy treatment).

This includes participants who can be discharged from orthopaedic care, but may need on-going allied health sessions (to be conducted outside this study), but they dont escalate to an orthopaedic review, they will still be classified as treatment success as they are discharged from care.

If the patient completes their Treatment plan but has not improved and now requires Orthopaedic referral for review- that will be classified as Treatment failure. as they are not discharged from care- they remain a patient within the orthopaedic department.
Timepoint [1] 325092 0
up to 3 months per patient- post completion of their treatment Plan
Secondary outcome [1] 386828 0
Does access to community-based allied health services lead to a reduction in referrals to orthopaedic outpatients?
as per review of hospital referral records
Timepoint [1] 386828 0
up to 12 months post intervention- averaged across subsidy arms- not by participant
Secondary outcome [2] 386829 0
Evaluation of costs of health care - by subsidy arm- using hospital cost codes linked to patient data
and MBS use- using MBS data
Timepoint [2] 386829 0
up to 24 mths- average across subsidy arms (not assessed by participant)

Eligibility
Key inclusion criteria
GPs: within the Cairns area (from the 16- 20 practices with the most orthopaedic referrals submitted in previous 12 months), will be recruited to manage and treat referred patients who have chronic musculoskeletal conditions; entry to the program via physio assessment

patients need to be 18-75 years
Eligibility Criteria Participants must be: direct GP referral to physio assessment via Cairns Hospital for a chronic orthopaedic or musculoskeletal condition, live and attend a GP (consented to be included in study) within the geographical catchment (Cairns area), patients must be adults (aged 18 years) to 75 years.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: patients with acute orthopaedic conditions, such as fractures, patients older than 75 years, residents of Residential Aged Care Facility (RACF), patients with congenital musculoskeletal conditions or permanent physical disabilities (paraplegia, cerebral palsy, spina bifida), patients with extremely complex orthopaedic conditions, such as previous Motor Vehicle Accident with multiple fractures, patients who are immuno-compromised, or currently receiving oncology specialist treatment, patients with intellectual disability &/or extensive psychiatric histories, impacting their ability to consent or comply with physiotherapy assessment and treatment.

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)
RCT- using sealed opaque envelopes GP practices will be randomised to one of four trial arms

Subsidy A- Control arm- Allied Health Market rate (standard) fees + (MBS- GPMP/TCA- 5 subsidised visits)
Participant to fund additional costs at market rate
Subsidy B- Participants to receive additional 5 subsidised sessions (equivalent of 10 GPMP/TCA sessions)
Participant to fund additional costs at market rate
Subsidy C- As per subsidy B- Participants receive equivalent of 10 GPMP/TCA sessions
Participants contribute $10-20 per session toward market rate
Subsidy D - Participants receive equivalent of 10 GPMP/TCA sessions
Participants to receive full gap payment (no out of pocket expenses)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
we will apply a Generalised Estimating Equation (GEE) model across subsidy arms to assess treatment success as defined by completion of MDT treatment plan and discharge from orthopaedic care. GEE models are suitable for these analyses as they produce semi-parametric models which report population average effects; furthermore, they can adjust for potential biases from different GPs: patient level data may not be independent . For this analyses demographic factors and comorbidities will be included as fixed effects and individual GPs will be set as random effects to adjust for potential biases.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
1/02/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 31235 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 306711 0
Government body
Name [1] 306711 0
NHMRC
Country [1] 306711 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 307259 0
Hospital
Name [1] 307259 0
Cairns Hospital
Address [1] 307259 0
165 The Esplanade
Cairns,
Queensland, 4879
Country [1] 307259 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306881 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [1] 306881 0
Ethics committee country [1] 306881 0
Australia
Date submitted for ethics approval [1] 306881 0
01/09/2020
Approval date [1] 306881 0
Ethics approval number [1] 306881 0

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

Contacts
Principal investigator
Name 105330 0
Dr Susan Jacups
Address 105330 0
c/o James Cook University
105 MacGregor Road
Smithfield,
Queensland, 4879
Country 105330 0
Australia
Phone 105330 0
+61449924659
Fax 105330 0
Email 105330 0
[email protected]
Contact person for public queries
Name 105331 0
Susan Jacups
Address 105331 0
c/o James Cook University
105 MacGregor Road
Smithfield,
Queensland, 4879
Country 105331 0
Australia
Phone 105331 0
+61449924659
Fax 105331 0
Email 105331 0
[email protected]
Contact person for scientific queries
Name 105332 0
Susan Jacups
Address 105332 0
c/o James Cook University
105 MacGregor Road
Smithfield,
Queensland, 4879
Country 105332 0
Australia
Phone 105332 0
+61449924659
Fax 105332 0
Email 105332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
consent will not be obtained for this level of data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9137Study protocol    380568-(Uploaded-11-09-2020-16-04-12)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.