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Trial registered on ANZCTR


Registration number
ACTRN12622000690752
Ethics application status
Approved
Date submitted
2/05/2022
Date registered
12/05/2022
Date last updated
28/07/2024
Date data sharing statement initially provided
12/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysing and Investigating Decision-Making Effectiveness: Knee Arthroplasty (AIDE-KA Trial)
Scientific title
Analysing and Investigating Decision Aid Effectiveness in Adults Suffering from Osteoarthritis and Considering Knee Arthroplasty (AIDE-KA Trial)
Secondary ID [1] 307037 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AIDE-KA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 326183 0
Patient Decision-Making 326184 0
Condition category
Condition code
Musculoskeletal 323488 323488 0 0
Osteoarthritis
Public Health 323489 323489 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A co-designed decision aid was created with the input from patients (pre- and post-knee arthroplasty), orthopaedic surgeons, rheumatologists, general practitioners and physiotherapists, along with up to date evidence from peer-reviewed literature. This decision aid covers many aspects of the decision including: 1) what is knee osteoarthritis; 2) what are the options for treatment; 3) what happens during a knee arthroplasty; 4) what do patients usually expect to achieve with surgery and if this actually happens; 5) how long an arthroplasty usually lasts; 6) when they can expect to see a benefit to their pain and function; 7) the possible harms and likelihood of them occuring; 8) what the benefits vs risks are for non-surgical and surgical treatment; and 9) questions they could ask their treating health professional. This decision aid was developed as per the International Patient Decision Aid Standards Collaboration guidelines (http://ipdas.ohri.ca/who.html; http://ipdas.ohri.ca/using.html). In this study, this co-designed decision aid will be randomly provided to patients in addition to the control (standard care). The patients randomised to this group will receive the decision aid at least 2 weeks prior to their intial consultation with the surgeon in either an electronic (PDF) or physical format (cardboard), based on their contact preference. Piloting indicated a strong patient preference for hardcopy, but with an option to receive an electronic version. This decision aid is theirs to keep forever with the only limitation being that it is for personal use only (patients will be allowed to request another copy if they lose the original). The anticipated time to completely read the material in one sitting is around 5 minutes, though patients may refer back to the material as many times as they wish. Adherence will be monitored by patient-reported use at 2 weeks following their initial consultation with the surgeon.
Intervention code [1] 323497 0
Lifestyle
Intervention code [2] 323525 0
Behaviour
Comparator / control treatment
Standard care refers to the usual education materials and/or advice that a surgeon would provide to their patients as part of their routine initial consultation protocol. Surgeons routinely provide education materials to their patients prior to, during or directly after an initial consultation. These materials are at the discretion of the surgeon and their unique clinical reasoning. Routine education materials may come in many different formats including referral to internet materials, pamphlets, verbal advice, etc., and are expected to be sought from reputable sources (in line with established high standards of care). There is a chance a surgeon, in their standard care, would prefer to not provide any physical materials to their patient. In all cases, the surgeons will not be asked to change their practice and will be expected to provide care/advice as they usually would.
Control group
Active

Outcomes
Primary outcome [1] 331238 0
Decision quality (Hip/Knee Decision Quality Instrument)
Timepoint [1] 331238 0
2 weeks post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [1] 409271 0
Impact of provided education materials on treatment chosen (Numerical Rating Scale)
Timepoint [1] 409271 0
2 weeks post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [2] 409272 0
Treatment chosen at time of review (single question asking if the patient has chosen to undertake a knee replacement, not undertake a knee replacement or is unsure of which option they would like to pursue; question sent using their preferred contact method)
Timepoint [2] 409272 0
2 weeks, 6 months and 1 year post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [3] 409273 0
Overall satisfaction with decision (Numerical Rating Scale)
Timepoint [3] 409273 0
2 weeks, 6 months and 1 year post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [4] 409274 0
Decisional conflict (Decisional Conflict Scale)
Timepoint [4] 409274 0
2 weeks post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [5] 409275 0
Decision regret (Decision Regret Scale)
Timepoint [5] 409275 0
6 months and 1 year post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [6] 409276 0
Function (Oxford Knee Score)
Timepoint [6] 409276 0
Prior to initial consulation (Baseline) and 1 year post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [7] 409277 0
Quality of Life (EQ-5D-5L)
Timepoint [7] 409277 0
Prior to initial consulation (Baseline) and 1 year post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)
Secondary outcome [8] 412175 0
Accessing to other health professionals to support decision (single question asking if the patient has accessed a surgeon or other health professional since intial consultation with primary surgeon; question sent using their preferred contact method)
Timepoint [8] 412175 0
2 weeks, 6 months and 1 year post initial consultation with surgeon (via a questionnaire sent out using their preferred contact method)

Eligibility
Key inclusion criteria
- Primary diagnosis of osteoarthritis
- Greater than or equal to 50 years old
- Referred to an orthopaedic surgeon, presenting with knee pain
- Considering whether to undergo knee arthroplasty
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of any type of knee osteoarthritis treatment decision aid in the prior 12 months
- A prior knee arthroplasty performed
- Any other significant injury to lower limb (e.g. fracture, aseptic necrosis, etc.) in the prior 12 months
- Cognitive impairment such that a patient is unable to independently consent to participate
- Unable to access assistance to complete questionnaires in English while at home

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)
Group assignment will be carried out centrally and randomly determined by computer generated code via a schedule formulated a priori in a REDCap Database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of patients to study group will occur using stratification by study site and in blocks of 2 and 4. This process will be performed by a research who is not an investigator on this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Random assignment will be allocated prior to patients attending their initial appointment with an orthopaedic surgeon, ideally at least two weeks in advance to allow for a reasonable time for patients to review the material sent to them. An independent researcher will be tasked with assigning and sending out the co-designed decision aid if they are allocated to that group. In this way data collectors and study personnel will be blinded to randomisation assignments, including when collecting follow up data.

This study will employ a limited disclosure approach where patients will be informed they will receive education material pertaining to their presentation/decision, but not specify if it will come from only the surgeons or the surgeons and the investigator co-designed decision aid. In this way patients will be blinded to their allocation.

A sub-group analysis will be performed at the conclusion of the study to test for difference between sites. Further, a blinded manuscript will be written for the two possible allocation scenarios. On completion, the investigators will then be unblinded and the paper reporting the correct allocation sequence will be published.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of 97 per group will provide 80% power to detect a 20% between-group difference in the proportion of subjects making a high quality decision (Stacey et al, 2014, BMC Musculoskeletal Disorders, 15:54), given a 2-tailed alpha of 0.05 and accounting for 15% loss to follow-up.

All analyses will be adjusted for baseline values and other previously identified confounders. For baseline data, categorical data will be presented as frequencies (%), and groups condensed as appropriate (clinic of consultation, insurance status, etc.). Continuous data such as age will be presented as mean (standard deviation) for normally distributed data, or median (range) for skewed data. Differences in distributions of variables will be assessed using chi square tests or Fisher’s exact test for categorical variables, or independent samples t-tests or Mann-Whitney U tests for continuous variables, where appropriate.

Selection of variables for univariable analysis will be based on existing literature on confounders and clinical relevance. Further, univariable associations between a quality of decision and pertinent confounding factors such as gender, insurance status, country of birth, etc will be assessed using chi-squared tests. Variables at or approaching significance at univariable analysis (cut-off set at p<0.20) will be included in multivariable analysis. A value of p<0.05 will be accepted as significant for multivariable analysis. Multivariable regression analyses will be used to examine for associations between the receipt of the co-designed decision aid and high quality decision-making (binary logistic regression for categorical and linear regression for continuous variables), adjusting for potential confounders (calculating between-group odds ratios (OR; categorical), mean differences (MD; continuous) and 95% confidence intervals (CI).

Continuous outcome measures will be converted to 0-100 point scale where appropriate and can be performed validly. Where formal analysis is unable to be performed, results will be presented descriptively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
28/07/2022
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
30/08/2025
Actual
Sample size
Target
165
Accrual to date
156
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22295 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 37457 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311350 0
Hospital
Name [1] 311350 0
Royal Prince Alfred Hospital
Country [1] 311350 0
Australia
Funding source category [2] 311353 0
Commercial sector/Industry
Name [2] 311353 0
The Hospitals Contribution Fund of Australia (HCF) Research Foundation
Country [2] 311353 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
Sydney Local Health District
Missenden Road
Camperdown, NSW
2050
Country
Australia
Secondary sponsor category [1] 312737 0
None
Name [1] 312737 0
Address [1] 312737 0
Country [1] 312737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310843 0
Concord Repatriation General Hospital, Sydney Local Health District
Ethics committee address [1] 310843 0
Ethics committee country [1] 310843 0
Australia
Date submitted for ethics approval [1] 310843 0
02/05/2022
Approval date [1] 310843 0
21/06/2022
Ethics approval number [1] 310843 0
CH62/6/2022-062

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

Contacts
Principal investigator
Name 119066 0
Prof Ian Harris
Address 119066 0
Department of Orthopaedic Surgery
Royal Prince Alfred Hospital
Sydney Local Health District
Missenden Road
Camperdown, NSW
2050
Country 119066 0
Australia
Phone 119066 0
+61 2 9515 7508
Fax 119066 0
+61 2 9515 5426
Email 119066 0
iaharris1@gmail.com
Contact person for public queries
Name 119067 0
Sascha Karunaratne
Address 119067 0
Royal Prince Alfred Hospital
PO Box M157
Camperdown, NSW
2050
Country 119067 0
Australia
Phone 119067 0
+61 2 9515 3464
Fax 119067 0
+61 2 9515 3222
Email 119067 0
Sascha.Karunaratne@health.nsw.gov.au
Contact person for scientific queries
Name 119068 0
Sascha Karunaratne
Address 119068 0
Royal Prince Alfred Hospital
PO Box M157
Camperdown, NSW
2050
Country 119068 0
Australia
Phone 119068 0
+61 2 9515 3464
Fax 119068 0
+61 2 9515 3222
Email 119068 0
Sascha.Karunaratne@health.nsw.gov.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?
Any de-identified data for studies approved both by the Chief Investigator of this study (Prof Harris) and a NHRMC approved HREC, will be shared.
When will data be available (start and end dates)?
Data will only be available post publication of all studies relating to the primary and secondary aims of this study in a peer-reviewed journal. It will be at the discretion of the Chief Investigator (Prof Harris) when this has been achieved. Data will be available in this way up to 5 years after the closure of the study, after which it will be destroyed as per protocol.
Available to whom?
Based on explicit consent from individual participants, de-identified individual patient data will be made available to researchers who comply with all regulations stipulated by a NHMRC approved Human Research Ethics Committee (HREC). Further, express written approval from Chief Investigator (Prof Harris) will be required (as per Research Data Management Plan).
Available for what types of analyses?
At the discretion of both the Chief Investigator (Prof Harris) and a NHRMC approved HREC, data will be made available for any approved analyses.
How or where can data be obtained?
A request to the Chief Investigator (Prof Harris; iaharris1@gmail.com) or Study Contact (Mr Karunaratne; Sascha.Karunaratne@health.nsw.gov.au) will be required. From here and consistent with the above and explicit data sharing policy in the Research Data Management Plan, a process of transfer stipulated by a NHRMC approved HREC will be followed on a case by case basis.


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.