Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001414707p
Ethics application status
Submitted, not yet approved
Date submitted
25/10/2022
Date registered
4/11/2022
Date last updated
4/11/2022
Date data sharing statement initially provided
4/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Taking the first step: Investigating the effect of novel strategies on the number of people with knee osteoarthritis accessing exercise management.
Scientific title
Taking the First Step: A cluster randomised implemention trial comparing novel implementation strategies on access to exercise programs for people with knee osteoarthritis
Secondary ID [1] 308265 0
Nil known
Universal Trial Number (UTN)
U1111-1284-3112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 328048 0
Condition category
Condition code
Musculoskeletal 325105 325105 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) A single educational reminder (3 lines of text and a hyperlink to current Royal Australian College of General Pracititoner guidelines for knee OA) included in x-ray report provided to the general practitioner (GP) at point of diagnosis. It is targeted at the GP, however if the person with knee osteoarthritis receives a copy of the report, they will also see the educational reminder message. Educational reminder message has been designed by the research team (consisting of physiotherapists, with more than 15 years experience, and exercise physiologists) in collaboration with general practitioners. It will be included in the reporting template from the radiology clinic performing and reporting on the x-ray.

The content of the educational message is:
If your patient has structural signs of osteoarthritis, you might refer them to a physiotherapist or an exercise physiologist. Structured land-based exercise programs are effective and safe for all patients with knee OA regardless of comorbidity. (Reference: The Royal Australia College of General Practitioners. Guideline for the management of knee and hip osteoarthritis. 2018).
- the citation will be hyperlinked.

(2) Educational reminder included in x-ray report and patient-facing infographic delivered to both the general practitioner and patient at point of diagnosis. Educational reminder message is same as above. The infographic is an A4 page taking approximately 1-2 minutes to read. It will be provided, in hard copy, to all people presented to the radiology clinic for a non-traumatic knee x-ray by staff at the radiology clinic. The infographic content has been developed in collaboration with a focus group of consumer advocates - all with knee osteoarthritis. Visual presentation was designed by a graphic designer.

Both interventions will be delivered once.
To monitor adherence, staff from the radiology clinic will complete a "office use only" section on all participant consent forms. This section includes a tick box to confirm (or otherwise) that the intervention was delivered. There is a question in the follow-up survey for patients to indicate if they received the infographic, this will be cross-referenced to group allocation. Finally, a process evaluation will take place throughout the trial to examine adherence of intervention delivery.
Intervention code [1] 324726 0
Behaviour
Comparator / control treatment
Current standard of care (no educational reminder message or infographic)
Control group
Active

Outcomes
Primary outcome [1] 332928 0
Referral to physiotherapy/exercise healthcare worker by GP or self. Outcome will be obtained via a self-reported survey accessed via a private link sent to the participant via text or email. The survey is hosted on REDCap.
Timepoint [1] 332928 0
4 weeks following x-ray
Secondary outcome [1] 415176 0
Attendance at physiotherapy/exercise healthcare appointment. Outcome will be obtained via a self-reported survey accessed via a private link sent to the participant via text or email. The survey is hosted on REDCap.
Timepoint [1] 415176 0
4-weeks following x-ray
Secondary outcome [2] 415177 0
Determinants of referral/attendance. These constructs will be assessed as composite measures via structured survey questions pertaining to
1. Patient motivation
2. Other management strategies offered or undertaken
3. Type of exercise professional referred to
4. Funding relief offered/obtained
Timepoint [2] 415177 0
4 weeks following x-ray
Secondary outcome [3] 415178 0
Implementation of interventions. Will be assessed using semi-structured interviews with a subsample of both participants and staff representing radiology clinics by a member of the research team. The subsample size will be determined based on thematic saturation.
Timepoint [3] 415178 0
5-6 weeks following delivery of the intervention (participants)
3 scheduled interviews (1-month into trial, at 50% of participant recruitment and within 1 month entire study post-enrollment) for each radiology site.
Secondary outcome [4] 415179 0
Mechanism of impact. Semi-structured interviews and study specific questions will be used to determine how participants responses to the interventions. Specifically, what were their perceptions and behaviour. Specific questions will include:
1. Did those who attend physiotherapy/exercise do so due to GP referral or self-referral?
2. Why did people in the intervention arms choose not to attend physiotherapy/exercise
3. Which changes mediate the association between the interventions and the outcomes?
4. What were the unanticipated effects or correlates of each intervention?
Timepoint [4] 415179 0
4-6 weeks following x-ray

Eligibility
Key inclusion criteria
(1) Radiology clinics
a. currently performing plain musculoskeletal x-rays
b. 1 or more radiologist agreeing to be involved;
c. current public liability insurance
d. able to use reporting templates for knee x-rays.
Where radiology franchises operate across several local government areas, the franchise will be approached to determine if each location uses a centralised reporting system and radiologist (e.g. one reporting radiologist across all sites). For practices that use a centralised reporting template/radiologist, only the clinics located in the largest clinic-cluster area will be considered for inclusion. If not, then all radiology clinics belonging to that franchise will be eligible for inclusion.

(2) People with knee OA
a. aged 45 years or older
b. has unilateral or bilateral knee pain of 6 months or longer duration
c. has been referred for the x-ray by a GP
d. holds a current Medicare card
e. is able to read or watch and understand the information and consent form without assistance from another person
f. is ambulatory (with or without the assistance of gait aids).
g. radiologically confirmed knee OA in any knee compartment
h. ability to participate in an email or telephone follow-up
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with knee OA:
x-ray referral as a direct result of knee trauma;
contraindication to routine knee x-ray;
referral for imaging from any medical specialists
compensable knee injury;
suspected musculoskeletal, cardiovascular or other pathology preventing activity-based interventions (e.g., chronic or terminal lung condition or malignancies);
prior knee replacement or awaiting knee replacement

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Radiology clinics will be stratified into 2 groups (based on Socio-Economic Indexes for Areas Index). Group randomisation will then occur through randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
10 radiology clinics will be recruited to each cluster - 5 from each targeted local government area. Each practice will recruit 102 people with knee OA.

A minimum sample of 850 patients per group is sufficient to find a 10% increase in the proportion of patients referred to physiotherapy/exercise in the strategy 1 group compared with the control. This is also sufficient power to find a 15% increase in the percentage of patients that receive a referral to physiotherapy/exercise in the strategy 2 when compared with the control group.

A multilevel model with a logit link and binomial distribution will be used to compare patient referrals between the groups using restricted likelihood estimation (REML). A random effect of ‘practice’ will be specified to account for clustering of the referrals within a practice, and a main predictor of group. Analysis will be adjusted for local government area if necessary. The same analyses will be performed using attending physiotherapy/exercise as the outcome

For implementation and mechanism of impact variables, a sub-set of participants will be recruited for semi-structured interview until saturation of themes has occurred. a thematic analysis will be conducted relating to acceptability of the different strategies, reasons underlying patient choices (including if they decided to self-refer for exercise), and feasibility.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3060
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312517 0
Commercial sector/Industry
Name [1] 312517 0
Hospitals Contribution Fund of Australia (HCF) Research Services Grant
Country [1] 312517 0
Australia
Funding source category [2] 312518 0
University
Name [2] 312518 0
Macquarie University
Country [2] 312518 0
Australia
Primary sponsor type
Individual
Name
Kathryn Mills
Address
C/- Department of Health Sciences
75 Talavera Road
Macquarie University, 2109
NSW, Australia
Country
Australia
Secondary sponsor category [1] 314108 0
Individual
Name [1] 314108 0
Justine Naylor
Address [1] 314108 0
Whitlam Orthopaedic Research Centre
Ingham Institute
Locked Bag 7103
Liverpool BC, 1871
NSW Australia
Country [1] 314108 0
Australia
Secondary sponsor category [2] 314110 0
Individual
Name [2] 314110 0
Jocelyn Bowden
Address [2] 314110 0
Kolling Institute of Bone and Joint Research
Royal North Shore Hospital
10 Westbourne St,
St Leonards 2064
NSW, Australia
Country [2] 314110 0
Australia
Secondary sponsor category [3] 314111 0
Individual
Name [3] 314111 0
Margery Pardey
Address [3] 314111 0
Macquarie Medical Injury
2 Technology Place
Macquarie University 2109
NSW, Australia
Country [3] 314111 0
Australia
Secondary sponsor category [4] 314113 0
Individual
Name [4] 314113 0
Robert Boland
Address [4] 314113 0
Faculty of Medicine and Health
The University of Sydney,
Science Rd,
Camperdown 2050
NSW, Australia
Country [4] 314113 0
Australia
Secondary sponsor category [5] 314114 0
Individual
Name [5] 314114 0
Joseph Descallar
Address [5] 314114 0
Ingham Institute
Locked Bag 7103
Liverpool BC, 1871
NSW Australia
Country [5] 314114 0
Australia
Other collaborator category [1] 282466 0
Individual
Name [1] 282466 0
Stephen Barnett
Address [1] 282466 0
Medcast
Level 12 92 Pitt Street
Sydney NSW 2000
Country [1] 282466 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311851 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 311851 0
Ethics committee country [1] 311851 0
Australia
Date submitted for ethics approval [1] 311851 0
01/06/2022
Approval date [1] 311851 0
Ethics approval number [1] 311851 0

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

Contacts
Principal investigator
Name 122598 0
Dr Kathryn Mills
Address 122598 0
C/- Department of Health Sciences
Ground Floor, 75 Talavera Road
Macquarie University 2109
NSW, Australia
Country 122598 0
Australia
Phone 122598 0
+61 2 9850 6624
Fax 122598 0
Email 122598 0
kathryn.mills@mq.edu.au
Contact person for public queries
Name 122599 0
Kathryn Mills
Address 122599 0
C/- Department of Health Sciences
Ground Floor, 75 Talavera Road
Macquarie University 2109
NSW, Australia
Country 122599 0
Australia
Phone 122599 0
+61 2 9850 6624
Fax 122599 0
Email 122599 0
kathryn.mills@mq.edu.au
Contact person for scientific queries
Name 122600 0
Kathryn Mills
Address 122600 0
C/- Department of Health Sciences
Ground Floor, 75 Talavera Road
Macquarie University 2109
NSW, Australia
Country 122600 0
Australia
Phone 122600 0
+61 2 9850 6624
Fax 122600 0
Email 122600 0
kathryn.mills@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be available on request to the research team. Prior ethics approval must be sought prior to data being provided
When will data be available (start and end dates)?
On completion of publication of the primary findings of the study. Data will be stored in perpetuity to align with NHMRC data management advice and there is no end date to data availability.
Available to whom?
Data will be available to researchers both within and exterior to the universities/research institutes of the research team members
Available for what types of analyses?
Data will be available for any purpose that an ethics committee has deemed to be aligned with the current aims of the study protocol.
How or where can data be obtained?
The nominated research teams (study sponsors) are data custodians of the data set. Data will be available by emailing a member of the research team: Kathryn.mills@mq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17462Study protocol  kathryn.mills@mq.edu.au Will be available as an attachment to this registr... [More Details]
17463Informed consent form  kathryn.mills@mq.edu.au Will be available as an attachment to this registr... [More Details]
17464Clinical study report  kathryn.mills@mq.edu.au
17465Ethical approval  kathryn.mills@mq.edu.au



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTaking the first step: Protocol for a cluster randomised implementation trial comparing strategies on access to exercise programmes for people with knee osteoarthritis.2023https://dx.doi.org/10.1136/bmjopen-2022-071045
N.B. These documents automatically identified may not have been verified by the study sponsor.