Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001196932p
Ethics application status
Submitted, not yet approved
Date submitted
13/08/2020
Date registered
10/11/2020
Date last updated
10/11/2020
Date data sharing statement initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the impact on in-hospital orthopaedic waitlists after introducing community-based advanced physiotherapy assessments for patients with chronic musculoskeletal conditions
Scientific title
Evaluating the impact on in-hospital orthopaedic waitlists after introducing community-based advanced physiotherapy assessments for patients with chronic musculoskeletal conditions
Secondary ID [1] 302022 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic musculoskeletal conditions 318599 0
Musculoskeletal 319367 0
Condition category
Condition code
Public Health 316618 316618 0 0
Health service research
Musculoskeletal 317329 317329 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention: a non- randomised control (comparing with historical data) trial
GPs can directly refer patients with chronic musculoskeletal conditions to Advanced physiotherapists for assessments

Advanced physiotherapists (level HP5) will have at least 5-10 years experience with additional orthopaedic training provided at the Cairns hospital orthopaedic unit for 6 mths prior to working independently in this role.

Face to face assessments at a Queensland health facility by the physio's, who will collect basic physical measurements and history of condition and current dietry information (as guided by dietitian)

these physical assessments by Advanced Physios will examine X-rays (trained to do so) and apply a number of validated/standardised examinations to assess strength, pain, movement, weightbearing capacity- and suitablity for further physiotherapy sessions- - they will also seek input from other allied health professionals- employed at the hospital- including dietitian, psychology and pharmacy (these professionals will not examine the participant, but offer advice based on information from the physio assessment (weight and height and lifestyle) and existing pharmacy use

Once assessed and discussed with the other allied health professionals (dietitican, psychology and pharmacy) they will create an individual plan for each participant- tailored to their condition and personal needs.

the number of recommended sessions with a physio/dietitian/psychologist and pharmacist will be included in a Plan- provided to the participant's GP, for discussion with them on how they are likely to undertake this plan using existing allied health services within the community. The GP will be able to provide an MBS funded chronic condition plan (MBS #723) that will reduce the out of pocket costs for the participant, for at least the first 5 session.

Most plans will involve 8-10 sessions

upon completion of the Plan- participants will be reviewed again by the Advanced Physio to check progress - completion of this with no further treatment requirements will mean they are removed (discharged) from the orthopaedic list-
if however, their treatment Plan has not been successful, they will be recommended to return to their GP for a referral to orthopaedics- where they should be fast tracked for assessment
Intervention code [1] 318322 0
Early detection / Screening
Comparator / control treatment
1. historical control comparator (waitlists and wait times to orthopaedics)
existing hospital data from 2018-2020 can be accessed on patient waitlists for orthopaedics and wait times (length of wait).
Control group
Historical

Outcomes
Primary outcome [1] 324741 0
Number of referrals for orthopaedic outpatients after the introduction of community-based advanced physiotherapy assessments-- compared standard treatment (historical referrals data comparisons)
Timepoint [1] 324741 0
referral numbers will be assessed every 6 months for 2 years post intervention
Primary outcome [2] 324742 0
average wait time on the in-hospital orthopaedic outpatient waitlist- Hospital data on waitlists available to assess changes pre/post intervention
Timepoint [2] 324742 0
waitlists will be assessed every 6 months for 2 years post intervention, for all collated participants enrolled in the study
Primary outcome [3] 325372 0
Number of patients on the waitlist (numbers) by category (3 categories as assessed by Orthopaedic specialist- depending on severity) for orthopaedic outpatients after the introduction of community-based advanced physiotherapy assessments-- compared standard treatment (historical waitlist data comparisons)
Timepoint [3] 325372 0
will be assessed every 6 months for 2 years post intervention, for all collated participants enrolled in the study
Secondary outcome [1] 385620 0
nil
Timepoint [1] 385620 0
nil

Eligibility
Key inclusion criteria
Consenting adults (ages 18-75) with a chronic musculoskeletal condition, who have been directly referred to the advanced physio assessment program.
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 MVA 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
Diagnosis
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
all participants will be offered the same intervention
we will compare outcomes with historical outcomes (from all presentations in previous 2 years 2018-2020), Comparing data with a 2 year period allows for seasonal peaks and troughs to be included in the comparison
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
data analyses will include student’s t-tests and generalised linear models, adjusted for demography where applicable. All statistical tests will be two-sided and performed using a 5% significance level with no adjustment for multiplicity.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
26/02/2024
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30963 0
4870 - Cairns City

Funding & Sponsors
Funding source category [1] 306445 0
Government body
Name [1] 306445 0
NHMRC
Country [1] 306445 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] 306961 0
Hospital
Name [1] 306961 0
Cairns Hospital
Address [1] 306961 0
165 The Esplanade Cairns , Queensland, 4870
Country [1] 306961 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306651 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [1] 306651 0
Ethics committee country [1] 306651 0
Australia
Date submitted for ethics approval [1] 306651 0
21/08/2020
Approval date [1] 306651 0
Ethics approval number [1] 306651 0

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

Contacts
Principal investigator
Name 104558 0
Dr Susan Jacups
Address 104558 0
c/o James Cook University
105 MacGregor Road
Smithfield,
Queensland, 4879
Country 104558 0
Australia
Phone 104558 0
+61449924659
Fax 104558 0
Email 104558 0
[email protected]
Contact person for public queries
Name 104559 0
Susan Jacups
Address 104559 0
c/o James Cook University
105 MacGregor Road
Smithfield,
Queensland, 4879
Country 104559 0
Australia
Phone 104559 0
+61449924659
Fax 104559 0
Email 104559 0
[email protected]
Contact person for scientific queries
Name 104560 0
Susan Jacups
Address 104560 0
c/o James Cook University
105 MacGregor Road
Smithfield,
Queensland, 4879
Country 104560 0
Australia
Phone 104560 0
+61449924659
Fax 104560 0
Email 104560 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
no individual consent will be obtained for this purpose


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8793Study protocol    380375-(Uploaded-11-09-2020-15-27-27)-Study-related document.doc



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.