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Trial registered on ANZCTR


Registration number
ACTRN12619000215123
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
14/02/2019
Date last updated
1/12/2024
Date data sharing statement initially provided
14/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of online data collection website into an orthopaedic clinic for Orthopaedic surgeons and patients with knee pain attending for consideration for a total knee joint replacement.
Scientific title
Implementation of online data collection website into an orthopaedic clinic for Orthopaedic surgeons and patients with knee pain attending for consideration for a total knee joint replacement.
Secondary ID [1] 294870 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 307821 0
Condition category
Condition code
Musculoskeletal 306868 306868 0 0
Osteoarthritis
Public Health 308220 308220 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is an interactive online database for surgeon use. The database will hold patient demographic and health status information and questionnaires collected during their attendance at an orthopaedic clinic for consideration of knee replacement surgery. Clinical assessment data derived from the surgeon’s examination will also be held within the database. For patients who undergo knee replacement, questionnaires and clinician assessments will also be collected during each clinic encounter for a period of 6 month post-surgery. All patients participating in this study will be required to complete a questionnaire consisting of the WOMAC and SF12 when they attend the clinic for any pre-operative visits where there is consideration of a knee joint replacement (determined by the referral of a patient for knee pain), and if they have surgery, at their six month post operative visit. This survey takes around 10-15 minutes to complete and will be answered online using a computer or a tablet. Surgeons will be required to complete an examination tab, containing field related to the physical examination of the patient and is in addition to their patient notes. This takes around 5 minutes to complete. Other data required to be entered into the database are surgical information and hospital admission data and creation of patient files, which will either be performed by clinic admin staff, the surgeons or research assistants.
There is also a qualitative aspect to this study which will interview a sub-section of patients and hospital staff (clinical admin staff and surgeons) involved in the implementation of this database, which will involve a semi-structured interview. The qualitative group will be interviewed post introduction of the database. This is likely to take place two-three months post implementation, but will depend on when the database has been fully operational within the clinic for a sustained amount of time to allow for useful and detailed responses.
Intervention code [1] 301183 0
Treatment: Surgery
Intervention code [2] 312217 0
Prevention
Comparator / control treatment
The control group will be compared with itself prior to the introduction of the intervention for this study.
Control group
Active

Outcomes
Primary outcome [1] 307202 0
The characteristics of patients who undergoing knee joint replacement, The characteristics are from the physical assessment of the patient by the surgeon and/or clinical staff and include weight and level of osteoarthritis.
Timepoint [1] 307202 0
At the patient's pre-surgery consultation. This time period between this consultation and surgery will be variable between sites.
Secondary outcome [1] 351105 0
Pain and Function of patients assessed via the WOMAC index questionnaire.
Timepoint [1] 351105 0
Pre-operative (at consultation visits)
6 month post operatively
Secondary outcome [2] 351106 0
Health-related quality of life assessed via the SF-12.
Timepoint [2] 351106 0
Pre-operatively (at consultation visits)
6 month post operatively
Secondary outcome [3] 351107 0
Post Operative complications assessed via chart review. Examples are surgical site infection, prosthetic joint infection, readmission to hospital within thirty days etc.
There will also be a linkage with Medicare data to fully capture complications arising from this research project (for example multiple operations indicating that the patient required reoperation due to a complication).
Timepoint [3] 351107 0
Post Operatively (up to six months)
Secondary outcome [4] 351108 0
Medication Use assessed via chart review. A linkage with the Pharmaceutical Benefits Scheme will enable the medication use of participating patients to be fully captured.
Timepoint [4] 351108 0
Post Operatively (up to six months).
Secondary outcome [5] 351109 0
Sustainability, which will be assessed by two ways. Quantitatively the number of times the smart database is used by the surgeon population ('number of hits'), will be examined using the website analytics of the Smart Ortho Database. This will allow researchers to explore if use of the database by surgeons increases or decreases from introduction, if a certain demographic of surgeons or a particular site use the database, and also the length of time surgeons use it, and also if surgeons are still using the database at the conclusion of the research project.
Qualitative Interviews will also be seeking feedback on the enablers and barriers faced by the surgeons whilst using the database, and this will provide further information on whether the database will be sustainable long term, or if barriers (such as difficulty in finding time to access or use the database) may limit its potential for sustainability.
Timepoint [5] 351109 0
Six months post operatively.
Secondary outcome [6] 351113 0
Health Economics Evaluation. Primary evaluation will be cost-effectiveness with a range of outcomes including incremental cost per extra person with a clinically significant improvement in pain and function and per extra quality-adjusted life year (QALYs) for intervention compared to control. Differences in QALY gains and costs between the control and intervention will be calculated using generalized linear regression models adjusted for baseline patient characteristics. Incremental cost per QALY will be calculated as the ratio of difference in mean cost to difference in mean QALYs, with results plotted on the cost-effectiveness plane and translated to the cost-acceptability curve. To account for missing data, multiple imputation of missing follow-up measures will be performed as a sensitivity analysis.
Timepoint [6] 351113 0
Six month post operative.

Eligibility
Key inclusion criteria
There are three populations who are the subject of this study.
Surgeon Group: Any surgeons who perform Total Knee Joint Replacement at a participating site will be eligible to participate.
Patients: Any patients who attend a clinic who have been referred from their general practitioner for consideration of a Total Knee Joint Replacement for treatment of knee osteoarthritis/knee pain.
Qualitative Aspect. Any patient, surgeon or hospital staff member who worked at, or visited, a clinic at a participating site whilst the database was being implemented, or used will be eligible to be included in the qualitative aspect of the research project.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There is no exclusion criteria. There is the opportunity for private surgeons to decline the installation and use of the Smart Ortho Database in their private rooms. Their patients will not be able to provide information to determine their level of suitability for this study, however, there is still the opportunity to capture post operative data via chart reviews and Medicare data. Therefore this is not an exclusion of that private surgeon's patients from the study as a whole. This is something that has been factored into the required response rate and the study overall.

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)
The sites that are participating are unaware of their allocation, or when they will switch from control to intervention. This information is held by the statistician and the primary investigator. The study coordinator, who is responsible for liaising with sites will be unaware of the allocation during the control phase. Once a site has successfully transitioned from control to implementation as per the randomized order, the primary investigator will inform the study coordinator of the next site to transition. This will be repeated for the length of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization sequence has been generated by a statistician blinded to the identity of sites and not involved in outcome analysis. The method of sequence generation was simple randomisation using a randomisation table created by computer software. The randomization lists the sites in order of them moving from the control arm to the intervention arm. This happens one site at a time, with a new site being exposed to the intervention at 12 week intervals.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other
Other design features
The trial is a stepped wedge cluster randomized clinical trial (SW-CRCT). In a SW-CRCT trial sites start in the control phase before switching over to the randomized phase at predefined time intervals (12 week) one site at a time. Each site acts as its own control, and has a variable length of time as a control/intervention phase dependent on their order of randomization. At the conclusion of this research all sites will have transitioned to the intervention arm.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recruitment Size Justification for Database Intervention
The statistical calculation for this required recruitment numbers was based on the following parameters; a step-wedge design, power of 80%,significance of 5 %, clusters of 8, sample ratio of 1:1, 4.3% minimum effect size and an intra-cluster correlation of 0.075. With these parameters the minimum sample size to detect an difference between the control group and intervention group is 696 knee replacements in total (348 in each arm of the study). Adjust for a 10% loss to follow-up this results in 766 knee replacements enrolled on the database overall, with 383 knee replacements per arm. There is no requirement for a minimum number of surgeons to contribute information to the database to reach this number.

Recruitment Size Justification for Qualitative Phase
There will be some overlap between patients who have been included on the database, (and therefore in the recruitment numbers above), and who will be included in these recruitment numbers as a section of participants for the qualitative phase will be drown from patients who have attended the clinics and been added to the database. However, there will be around 170 patients recruited for the qualitative research project. It is anticipated that recruitment of participants for the qualitative interviews will continue until saturation is reached for the research project.

Total Recruitment Size: 170 + 766 = 936. However over recruitment is a possibility, and is allowable in both the study and the design of the database.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2019
Actual
23/09/2019
Date of last participant enrolment
Anticipated
31/12/2022
Actual
31/12/2022
Date of last data collection
Anticipated
30/06/2023
Actual
30/06/2023
Sample size
Target
936
Accrual to date
Final
1032
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11726 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 11730 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 23809 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 299457 0
Government body
Name [1] 299457 0
National Health and Medical Research Council
Country [1] 299457 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Michelle Dowsey
Address
Department of Orthopaedics
St. Vincent's Hospital
Level 3, Daly Wing
35 Victoria Parade
Fitzroy 3065
PO Box 2900
Country
Australia
Secondary sponsor category [1] 298755 0
None
Name [1] 298755 0
Address [1] 298755 0
Country [1] 298755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300363 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 300363 0
Ethics committee country [1] 300363 0
Australia
Date submitted for ethics approval [1] 300363 0
22/05/2018
Approval date [1] 300363 0
10/08/2018
Ethics approval number [1] 300363 0
HREC/18/SVHM/184

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

Contacts
Principal investigator
Name 83410 0
A/Prof Michelle Dowsey
Address 83410 0
Department of Orthopaedics
St. Vincent's Hospital
Level 3, Daly Wing
35 Victoria Parade
Fitzroy 3065
PO Box 2900
Country 83410 0
Australia
Phone 83410 0
+61 3 9231 4586
Fax 83410 0
Email 83410 0
mmdowsey@svha.org.au
Contact person for public queries
Name 83411 0
Claire Weeden
Address 83411 0
Department of Orthopaedics
St. Vincent's Hospital
Level 3, Daly Wing
35 Victoria Parade
Fitzroy 3065
PO Box 2900
Country 83411 0
Australia
Phone 83411 0
+61 3 9231 3955
Fax 83411 0
Email 83411 0
mmdowsey@unimelb.edu.au
Contact person for scientific queries
Name 83412 0
Claire Weeden
Address 83412 0
Department of Orthopaedics
St. Vincent's Hospital
Level 3, Daly Wing
35 Victoria Parade
Fitzroy 3065
PO Box 2900
Country 83412 0
Australia
Phone 83412 0
+613 9231 4586
Fax 83412 0
Email 83412 0
claire.weeden@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The database contains sensitive and private data from the two groups of patients. There is sensitive medical and health data (from patients) and medical decision and physical assessment data (from surgeons). This data is private and therefore will not be made available. There is no level of de-identification that would entirely remove identifiable markers for either surgeon and patient.


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.