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Trial registered on ANZCTR


Registration number
ACTRN12620000218998
Ethics application status
Approved
Date submitted
8/01/2020
Date registered
24/02/2020
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a physiotherapy led, multidisciplinary model of care for the management of knee osteoarthritis in community practice: a pilot study
Scientific title
Implementation of a physiotherapy led, multidisciplinary model of care for the management of knee osteoarthritis in community practice: a pilot study of acceptability and effectiveness
Secondary ID [1] 300210 0
Nil known
Universal Trial Number (UTN)
U1111-1246-1598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 315768 0
Condition category
Condition code
Musculoskeletal 314053 314053 0 0
Osteoarthritis
Public Health 314054 314054 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be co-designed in consultation with the physiotherapists and physiotherapy practices over a 2-month period. Further feedback will be gained from community representatives from the Sydney Partnership for Health, Education, Research and Enterprise (SPHERE) Community and Consumer Council (CCC) for Musculoskeletal Health.
Consultation will occur face to face within the physiotherapy practices in small group sessions conducted by the lead researcher, with each session running for approximately 1 hour. The first round of focus groups will highlight what the current guidelines are for the conservative management of knee osteoarthritis (OA), and aspects of practice that deviate or align with these recommended guidelines (based on data obtained from pre-intervention interviews). De-identified patient commentary will be provided on how individuals with knee OA perceived the treatment they received. Discussion regarding the benefits and limitations of Patient reported outcome measures (PROMs) and their availability for use will be included. The current use of exercise therapy and multidisciplinary input will be reviewed, and consensus sought on appropriate practice changes to be implemented if necessary, to align with current guidelines. The draft model will be presented for further feedback at a second round of focus sessions.
The intervention will be based on current guidelines regarding the management of knee OA, education, exercises, self-management and weight loss (if indicated). Information on these guidelines will be provided for patients verbally and in writing by the physiotherapists. A proforma will be developed for the physiotherapists to use during assessments of the recruited patients. A third round of focus sessions will be conducted to discuss strategies for implementation of the intervention, provide training, and include role play to develop the physiotherapists confidence to deliver the intervention and improve knowledge. A ‘champion’ will be identified at each practice, as a key contact for physiotherapists and the lead researcher. The lead researcher will also be in contact with all physiotherapy practices throughout the project, to provide ongoing support.
All consultation will be conducted by the lead researcher, face to face, in small groups, within the physiotherapy practices.
The intervention will be delivered by physiotherapists with a range of experience levels, across nine Sydney metropolitan-based, community physiotherapy practices. Each participant will take part in the intervention over a 6-week period. The physiotherapist will personalise the delivery of the intervention to suit the patients need, including number of physiotherapy sessions, duration and intensity. Each physiotherapy session will have a duration of approximately 30 mins, the number of sessions will be determined by the patient’s preference, capability, and availability of resources.
Exercises will be prescribed in line with current guidelines for the management of knee OA, and will be tailored to each patients level of ability. The exercises prescribed will include strengthening (particularly quadriceps), active range of movement, stretching, and aerobic activity. The intensity of exercises will be measured using a visual analogue scale of 0-10, working at an intensity of 0-5, with pain subsiding to the patients normal pain level (same level their pain was prior to exercising) the day after. Exercises will be assessed by the physiotherapist at each session, so that dosage can be progressed.
Adherence to the intervention will be monitored by exercise frequency checklists at each physiotherapy session.


Intervention code [1] 316483 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322451 0
Primary outcome 1 - Proportion of patients who are recorded as receiving care according to guidelines, as assessed by audit of patient treatment notes.
Timepoint [1] 322451 0
Timepoint. at 6 weeks after recruitment.
Primary outcome [2] 322452 0
Primary outcome 2 - Proportion of patients who have patient-reported outcomes incorporated into their assessment and management plan, as assessed by audit of patient treatment notes.
Timepoint [2] 322452 0
Timepoint. at 6 weeks after recruitment.
Primary outcome [3] 322453 0
Primary outcome 3 - Acceptability of the developed model to the physiotherapists where acceptability reflects the extent to which the patients and physiotherapists consider the intervention to be appropriate (level of satisfaction) based on what they anticipated or experienced, as assessed by interview of patients and physiotherapists. Interviews will take approximately 30 mins in a one-to-one format, either, face to face or by telephone as able.
Timepoint [3] 322453 0
Timepoint. at 6 weeks after recruitment of final participant.
Secondary outcome [1] 378583 0
Secondary outcome 1 – knee stiffness, as assessed by patient reported outcome (Knee injury and Osteoarthritis Outcome Score)
Timepoint [1] 378583 0
Timepoint. Baseline and 12 weeks after recruitment.
Secondary outcome [2] 378584 0
Secondary outcome 2 – knee pain, as assessed by patient reported outcomes (Knee injury and Osteoarthritis Outcome Score and Multidimensional Health Assessment Questionnaire)
Timepoint [2] 378584 0
Timepoint. Baseline and 12 weeks after recruitment.
Secondary outcome [3] 378585 0
Secondary outcome 3 – knee function, as assessed by patient reported outcomes (Knee injury and Osteoarthritis Outcome Score and Multidimensional Health Assessment Questionnaire)
Timepoint [3] 378585 0
Timepoint. Baseline and 12 weeks after recruitment.
Secondary outcome [4] 378586 0
Secondary outcome 3 – Polysymptomatic distress, as assessed by patient reported outcomes (2011 Fibromyalgia criteria questionnaire)
Timepoint [4] 378586 0
Timepoint. Baseline and 12 weeks after recruitment.

Eligibility
Key inclusion criteria
People who present with knee OA defined as
• activity related joint pain
• morning stiffness<30 mins
• over 45 years old
These participants may also have
. bony enlargement
• crepitus on active motion
• deformity fixed flexion
• +/-varus/valgus
• knee instability
• peri-articular or joint tenderness
• pain on patellar femoral compression
• swelling
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from participation if they have
• inflammatory arthritis
• rheumatoid arthritis
• gout
• history of/or current infection in the joint
• cognitive impairment
• significant trauma
• hemi or total knee replacement of affected joint
• have had knee surgery in the last 12 months
• or are being treated under workers compensation

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are aiming for an opportunistic sample size of 30 participants, ideally achieving 3-4 patients per practice. Whilst 12 people typically provide sufficient information for theme saturation in qualitative studies, we aim to enrol participants from each clinic in order to get a mix of socioeconomic backgrounds. Further, the relatively large sample will provide evidence of a trend in efficacy (if there is one), that will inform sample size calculations for future studies.

Analysis
Audit of Treatment Notes
Data collected through the auditing of treatment notes in the pre-intervention stage will be recorded in Microsoft excel spreadsheets and analysed using descriptive statistics (mean, standard deviation, and proportion) as follows: The percent of patients who received each of the core guideline treatments and the percent of patients who were referred to another healthcare professional for each of the core guideline treatments.
Post-intervention treatment notes will be audited to test for change in treatment due to the intervention. Data will be recorded in Microsoft excel spreadsheets and analysed as in the pre intervention phase, using descriptive statistics (mean, standard deviation, and proportion) as follows: The percent of change in the inclusion of core guideline treatments, the percent of change in use of PROMs, the percent of change in referrals to other healthcare professionals for each of the core guideline treatments and percent of change in physiotherapists confidence to deliver treatment and percent of change in patient satisfaction with the management of their OA knee.
Audited treatment notes will be compared against care that is recommended in guidelines for the conservative management of knee OA, However, descriptive statistics of the patient will determine if all core guideline treatments need to be address. For example, if the patient is obese, weight-management should be discussed, and a referral to a dietician made. But, if they had a BMI < 25, this treatment would be made null.
Secondary outcomes
Secondary outcomes from the quasi-experimental part of the study include a comparison of the change in PROMS across time (before and after treatment).
PROMs
Demographic and clinical characteristics will be collected through the use of PROMs at initial recruitment and 12 weeks. The baseline characteristics of the two cohorts will be presented to demonstrate comparability. The change in PROMS across time for each cohort will also be presented.
Qualitative component
Patients experience and perspectives of how their knee OA was managed will be gathered using a semi-structured face to face interview at 4-6 weeks post recruitment.
Physiotherapists experience and perspectives of how they manage knee OA will be gathered using a semi -structured face to face interview when pre-intervention recruitment is completed.
Semi-structured interviews will be conducted, audio-recorded and transcribed. Data collected from interviews will be recorded in nVivo were it will be categorised and classified. This will reflect both the patients and physiotherapists experiences and perceptions.
Focus groups
The physiotherapists, who will implement the model of care will participate in two focus groups, which will be audio-recorded and transcribed. The data collected will be analysed using nVivo. This will reflect both the patients and physiotherapists experiences and perceptions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
23/10/2020
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28972 0
2000 - Haymarket
Recruitment postcode(s) [2] 28973 0
2560 - Campbelltown
Recruitment postcode(s) [3] 28974 0
2068 - Willoughby
Recruitment postcode(s) [4] 28975 0
2063 - Northbridge
Recruitment postcode(s) [5] 28976 0
2170 - Mount Pritchard
Recruitment postcode(s) [6] 28977 0
2170 - Liverpool
Recruitment postcode(s) [7] 28978 0
2154 - Castle Hill
Recruitment postcode(s) [8] 28979 0
2000 - Sydney
Recruitment postcode(s) [9] 28980 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 304642 0
Other Collaborative groups
Name [1] 304642 0
Sydney Translational Research and Education Alliance for Musculoskeletal (STREAM) Health
Country [1] 304642 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 304941 0
Other
Name [1] 304941 0
Neuroscience Research Australia (NeuRA)
Address [1] 304941 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street
Randwick, Sydney,
NSW 2031
Country [1] 304941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305063 0
The University of New South Wales Human Research Ethics Advisory Panel D
Ethics committee address [1] 305063 0
Ethics committee country [1] 305063 0
Australia
Date submitted for ethics approval [1] 305063 0
05/11/2018
Approval date [1] 305063 0
05/02/2019
Ethics approval number [1] 305063 0
HC180864

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

Contacts
Principal investigator
Name 99138 0
Mrs Rebecca Livings
Address 99138 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031
Country 99138 0
Australia
Phone 99138 0
+61 0428071588
Fax 99138 0
Email 99138 0
r.livings@neura.edu.au
Contact person for public queries
Name 99139 0
Rebecca Livings
Address 99139 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031
Country 99139 0
Australia
Phone 99139 0
+61 0428071588
Fax 99139 0
Email 99139 0
r.livings@neura.edu.au
Contact person for scientific queries
Name 99140 0
Rebecca Livings
Address 99140 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031
Country 99140 0
Australia
Phone 99140 0
+61 0428071588
Fax 99140 0
Email 99140 0
r.livings@neura.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?
All of the individual data collected during the study, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months following main results publication, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approval proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator
r.livings@neura.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6704Study protocol  r.livings@neura.edu.au
6705Ethical approval  r.livings@neura.edu.au



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.