Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000204741
Ethics application status
Approved
Date submitted
18/01/2022
Date registered
7/02/2022
Date last updated
24/01/2023
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
DECIDE study - Evaluating information provided for people with knee osteoarthritis considering surgery: a randomised controlled trial
Scientific title
Evaluating the effect of a decision tool on the rate of orthopaedic surgeon referral in people with knee osteoarthritis considering arthroscopy: a randomised controlled trial (DECIDE study)
Secondary ID [1] 304835 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DECIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative knee disease 322921 0
Osteoarthritis 325102 0
Degenerative meniscal tears 325103 0
Loose bodies within the knee joint 325104 0
Condition category
Condition code
Musculoskeletal 320495 320495 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Patient decision tool

All patients allocated to the intervention group will be emailed a written patient decision tool after completing the eligibility screening and consent form. At the same time, they will also receive information readily available electronically – an Arthritis Australia information sheet about osteoarthritis. This provides general information about the condition and how to manage it but no information about surgical options.

The decision tool is designed to help people with knee osteoarthritis decide whether or not they should have arthroscopic surgery. The decision tool provides a general introduction, an explicit statement of the decision to be taken (‘should I have arthroscopic surgery?’), and describes the likely benefits and harms of arthroscopic surgery compared with not having surgery. Estimates are provided using pictographs and described in words with the source of estimates explicitly stated. Key practical issues associated with each option is provided, as well as information on other treatment options.

Patients will be allocated to the intervention group or the control group.

The intervention will not be personalised. Adherence will not be assessed.
Intervention code [1] 321215 0
Behaviour
Comparator / control treatment
Patients in the control group will receive an Arthritis Australia information sheet about osteoarthritis that is readily available online. This provides general information about the condition and how to manage it but no information about surgical options. This will be emailed to participants after the completion of the eligibility screening and consent form.
Control group
Active

Outcomes
Primary outcome [1] 328325 0
Referral to an orthopaedic surgeon for consideration of knee arthroscopy: measured as the proportion of participants in each group who report being referred to an orthopaedic surgeon for consideration of knee arthroscopy at any time up to six months post intervention. Participant-reported and collected via telephone interview.
Timepoint [1] 328325 0
6 months post intervention
Secondary outcome [1] 398606 0
Referral to an orthopaedic surgeon for consideration of knee arthroscopy at any time up to 12 months post intervention. Participant-reported and collected via survey developed for this study.
Timepoint [1] 398606 0
12 months post intervention
Secondary outcome [2] 398608 0
Referral to an orthopaedic surgeon for any reason: measured as the proportion of participants in each group who report being referred to an orthopaedic surgeon for any reason including arthroscopy, arthroplasty, other, at any time up to six months post intervention. Participant-reported and collected via telephone interview.
Timepoint [2] 398608 0
6 months post intervention
Secondary outcome [3] 398609 0
Referral to an orthopaedic surgeon for any reason: measured as the proportion of participants in each group who report being referred to an orthopaedic surgeon for any reason including arthroscopy, arthroplasty, other, at any time up to 12 months post intervention. Participant-reported and collected via survey developed for this study.
Timepoint [3] 398609 0
12 months post intervention
Secondary outcome [4] 405748 0
Knowledge about the effects of arthroscopic surgery for knee osteoarthritis: measured on 5 domains (pain, function, quality of life, treatment success and risks) with multiple choice response options. Participant-reported and collected via survey developed for this study.
Timepoint [4] 405748 0
Baseline, 2 weeks and 6 months post intervention
Secondary outcome [5] 405749 0
Intention to request surgical referral for knee arthroscopy: measured using a single item with 5-point Likert scale response option. Participant-reported and collected via survey.
Timepoint [5] 405749 0
Baseline, 2 weeks and 6 months post intervention
Secondary outcome [6] 405750 0
Attitudes towards knee arthroscopy: measured using 5 items with 5-point Likert scale response options. Participant-reported and collected via survey.
Timepoint [6] 405750 0
2 weeks and 6 months post intervention
Secondary outcome [7] 405751 0
Quality of the decision-making process: measured using the Decisional Conflict Scale (DCS) (16 items with 5-point Likert scale response options). Participant-reported and collected via survey.
Timepoint [7] 405751 0
2 weeks and 6 months post intervention
Secondary outcome [8] 405752 0
Satisfaction with preparation for making a decision: measured using the Preparation for Decision Making Scale (10 items with 5-point Likert scale response options). Participant-reported and collected via survey.
Timepoint [8] 405752 0
2 weeks and 6 months post intervention
Secondary outcome [9] 405753 0
Informed choice: a composite measure of knowledge, attitudes and treatment intentions. Participant-reported and collected via survey. Participants will be considered to have made an informed treatment choice when they have sufficient conceptual knowledge (greater than or equal to 3 out of 4 score on Knowledge questionnaire), and attitudes that align with their treatment intentions. Attitudes align with treatment intentions when: - A participant has positive attitudes towards knee arthroscopy (greater than or equal to 20 on Attitudes questionnaire) and intends to request referral to a surgeon for consideration of knee arthroscopy. - A participant has negative attitudes towards knee arthroscopy (less than 20 score on Attitudes questionnaire) and intends not to request referral to a surgeon for consideration of knee arthroscopy. Participants with insufficient knowledge, or attitudes that do not align with their treatment intentions will be considered as making an uninformed choice.
Timepoint [9] 405753 0
2 weeks and 6 months post intervention
Secondary outcome [10] 405754 0
Attendance at an orthopaedic surgeon consultation: measured as the proportion of participants in each group who report attending an orthopaedic surgeon consultation. Participant-reported and collected via telephone interview.
Timepoint [10] 405754 0
6 months post intervention
Secondary outcome [11] 405755 0
Attendance at an orthopaedic surgeon consultation: measured as the proportion of participants in each group who report attending an orthopaedic surgeon consultation. Participant-reported and collected via survey developed for this study.
Timepoint [11] 405755 0
12 months post intervention
Secondary outcome [12] 405756 0
Offered knee arthroscopy by an orthopaedic surgeon; measured as the proportion of participants in each group who report being offered knee arthroscopy by an orthopaedic surgeon. Participant-reported and collected via telephone interview.
Timepoint [12] 405756 0
6 months post intervention
Secondary outcome [13] 405757 0
Offered knee arthroscopy by an orthopaedic surgeon; measured as the proportion of participants in each group who report being offered knee arthroscopy by an orthopaedic surgeon. Participant-reported and collected via survey developed for this study.
Timepoint [13] 405757 0
12 months post intervention
Secondary outcome [14] 405758 0
Knee arthroscopy performed or waitlisted for knee arthroscopy: measured as the proportion of participants in each group who report having undergone knee arthroscopy or being waitlisted to undergo knee arthroscopy. Participant-reported and collected via telephone interview.
Timepoint [14] 405758 0
6 months post intervention
Secondary outcome [15] 405759 0
Knee arthroscopy performed or waitlisted for knee arthroscopy: measured as the proportion of participants in each group who report having undergone knee arthroscopy or being waitlisted to undergo knee arthroscopy. Participant-reported and collected via survey developed for this study.
Timepoint [15] 405759 0
12 months post intervention
Secondary outcome [16] 405760 0
Knee arthroscopy performed at up to 12 months post intervention: measured using MBS data.
Timepoint [16] 405760 0
12 months post intervention
Secondary outcome [17] 405761 0
Knee surgery other than arthroscopy (replacement or osteotomy) at up to 12 months post intervention: measured using MBS data.
Timepoint [17] 405761 0
12 months post intervention
Secondary outcome [18] 405762 0
Use of opioids during the 12-month period post intervention: measured using PBS data.
Timepoint [18] 405762 0
12 months post intervention
Secondary outcome [19] 405763 0
Use of other prescription analgesics during the 12-month period post intervention: measured using PBS data.
Timepoint [19] 405763 0
12 months post intervention

Eligibility
Key inclusion criteria
Participants will be eligible if they:
1) are aged 45 years or older;
2) have doctor-diagnosed degenerative knee disease (osteoarthritis, meniscal tears and/or loose bodies causing mechanical symptoms); and
3) have considered or talked to a health professional about knee arthroscopy.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
1) have a diagnosis of inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis);
2) have undergone pervious arthroscopy surgery of either knee;
3) have bilateral total knee replacements;
4) are not comfortable reading and answering questions in English.

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)
Participants will be enrolled through an online survey hosted on Qualtrics. After each participant consents to participate they will be randomised to either the intervention or control group through an online randomisation system. This online system holds the randomisation sequence produced by a statistician independent of the trial team and keeps the randomisation sequence secure and only permits randomisation of participants once consent is obtained and participant details are entered. The automated system will then distribute the allocated intervention to participants via email. Participants will be blinded to group allocation by informing them that the trial involves testing two interventions but not defining the specific difference between these, or which is hypothesised to be more effective.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using permuted blocks of random size (4 to 6). A statistician independent of the trial team will produce the randomisation sequence using computer-generated random numbers and will have no role in recruiting or consenting participants. An online randomisation system will be set up to keep the randomisation sequence secure and only permit randomisation of participants once consent is obtained and participant details are entered.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome (number of participants referred to a surgeon for consideration of knee arthroscopy by six months), we judge an absolute difference of 10-15% to be relevant. Assuming conservatively that the rate of referral for surgical assessment in the control (receipt of osteoarthritis information only) group is 20%, in order to achieve 90% power to detect a group difference of 10% with a two-sided significance level of 5%, we require 266 participants per arm. Assuming an attrition rate of 10% at six months follow-up, we will aim to randomise 592 participants.

The primary analysis will consist of a simple chi-square test comparing the proportion of people referred for consideration of knee arthroscopy by 6 months. The effect of the intervention will be summarised both as the absolute difference in proportions and its 95% confidence interval and as the relative risk and its 95% confidence interval. Sensitivity analyses adjusted for key baseline covariates will be performed using log-binomial or logistic regression. Multiple imputation will be used to handle missing data. A similar approach will be used to analyse the secondary outcomes.

Additional models with additional baseline covariates will be considered together with subgroup analyses. Details will be pre-specified in a separate statistical analysis plan developed with no access to unblinded trial data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/07/2022
Actual
8/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
592
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309208 0
Charities/Societies/Foundations
Name [1] 309208 0
Cabrini Foundation
Country [1] 309208 0
Australia
Funding source category [2] 310588 0
Other Collaborative groups
Name [2] 310588 0
Wiser Healthcare Collaboration
Country [2] 310588 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton, VIC, 3800
Country
Australia
Secondary sponsor category [1] 310170 0
Other
Name [1] 310170 0
Cabrini Health
Address [1] 310170 0
154 Wattletree Road
Malvern, VIC, 3144
Country [1] 310170 0
Australia
Other collaborator category [1] 281915 0
Other Collaborative groups
Name [1] 281915 0
Wiser Healthcare Collaboration
Address [1] 281915 0
c/o Rachelle Buchbinder
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
154 Wattletree Road
Malvern, VIC, 3144
Country [1] 281915 0
Australia
Other collaborator category [2] 282132 0
Other Collaborative groups
Name [2] 282132 0
Australia & New Zealand Musculoskeletal Clinical Trials Network (ANZMUSC)
Address [2] 282132 0
c/o Rachelle Buchbinder
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
154 Wattletree Road
Malvern, VIC, 3144
Country [2] 282132 0
Australia
Other collaborator category [3] 282154 0
Individual
Name [3] 282154 0
Prof Rachelle Buchbinder (Co-principal investigator)
Address [3] 282154 0
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144
Country [3] 282154 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309059 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 309059 0
Monash University
Wellington Road
Clayton, VIC, 3800
Ethics committee country [1] 309059 0
Australia
Date submitted for ethics approval [1] 309059 0
24/08/2020
Approval date [1] 309059 0
07/10/2020
Ethics approval number [1] 309059 0
25864

Summary
Brief summary
This study aims to assess the effectiveness of providing information about osteoarthritis and its management to people with knee osteoarthritis. Information about osteoarthritis and its management may help people make more informed decisions about the care they receive and the decision on whether or not to undergo surgery. Participants in this study will be randomly allocated to one of two study groups, each receiving a different intervention.
Trial website
www.decidestudy.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112826 0
A/Prof Denise O’Connor
Address 112826 0
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144
Country 112826 0
Australia
Phone 112826 0
+61 3 9508 3428
Fax 112826 0
Email 112826 0
[email protected]
Contact person for public queries
Name 112827 0
A/Prof Denise O’Connor
Address 112827 0
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144
Country 112827 0
Australia
Phone 112827 0
+61 3 9508 3428
Fax 112827 0
Email 112827 0
[email protected]
Contact person for scientific queries
Name 112828 0
A/Prof Denise O’Connor
Address 112828 0
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144
Country 112828 0
Australia
Phone 112828 0
+61 3 9508 3428
Fax 112828 0
Email 112828 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12620Study protocol  [email protected]
12621Statistical analysis plan  [email protected]



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.