ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

DECIDE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Degenerative knee disease

Osteoarthritis

Degenerative meniscal tears

Loose bodies within the knee joint

Condition category

Condition code

Musculoskeletal

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]

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]

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]

6 months post intervention

Secondary outcome [1]

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]

12 months post intervention

Secondary outcome [2]

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]

6 months post intervention

Secondary outcome [3]

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]

12 months post intervention

Secondary outcome [4]

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]

Baseline, 2 weeks and 6 months post intervention

Secondary outcome [5]

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]

Baseline, 2 weeks and 6 months post intervention

Secondary outcome [6]

Attitudes towards knee arthroscopy: measured using 5 items with 5-point Likert scale response options. Participant-reported and collected via survey.

Timepoint [6]

2 weeks and 6 months post intervention

Secondary outcome [7]

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]

2 weeks and 6 months post intervention

Secondary outcome [8]

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]

2 weeks and 6 months post intervention

Secondary outcome [9]

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]

2 weeks and 6 months post intervention

Secondary outcome [10]

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]

6 months post intervention

Secondary outcome [11]

Timepoint [11]

12 months post intervention

Secondary outcome [12]

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]

6 months post intervention

Secondary outcome [13]

Timepoint [13]

12 months post intervention

Secondary outcome [14]

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]

6 months post intervention

Secondary outcome [15]

Timepoint [15]

12 months post intervention

Secondary outcome [16]

Knee arthroscopy performed at up to 12 months post intervention: measured using MBS data.

Timepoint [16]

12 months post intervention

Secondary outcome [17]

Knee surgery other than arthroscopy (replacement or osteotomy) at up to 12 months post intervention: measured using MBS data.

Timepoint [17]

12 months post intervention

Secondary outcome [18]

Use of opioids during the 12-month period post intervention: measured using PBS data.

Timepoint [18]

12 months post intervention

Secondary outcome [19]

Use of other prescription analgesics during the 12-month period post intervention: measured using PBS data.

Timepoint [19]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cabrini Foundation

Address [1]

154 Wattletree Road
Malvern, VIC, 3144

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Wiser Healthcare Collaboration

Address [2]

c/o Rachelle Buchbinder
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
154 Wattletree Road
Malvern, VIC, 3144

Country [2]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Road
Clayton, VIC, 3800

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Cabrini Health

Address [1]

154 Wattletree Road
Malvern, VIC, 3144

Country [1]

Australia

Other collaborator category [1]

Other Collaborative groups

Name [1]

Wiser Healthcare Collaboration

Address [1]

c/o Rachelle Buchbinder
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
154 Wattletree Road
Malvern, VIC, 3144

Country [1]

Australia

Other collaborator category [2]

Other Collaborative groups

Name [2]

Australia & New Zealand Musculoskeletal Clinical Trials Network (ANZMUSC)

Address [2]

c/o Rachelle Buchbinder
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
154 Wattletree Road
Malvern, VIC, 3144

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Prof Rachelle Buchbinder (Co-principal investigator)

Address [3]

Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University
Wellington Road
Clayton, VIC, 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/08/2020

Approval date [1]

07/10/2020

Ethics approval number [1]

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

A/Prof Denise O’Connor

Address

Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144

Country

Australia

Phone

+61 3 9508 3428

Fax

[email protected]

Contact person for public queries

Name

Denise O’Connor

Address

Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144

Country

Australia

Phone

+61 3 9508 3428

Fax

[email protected]

Contact person for scientific queries

Name

Denise O’Connor

Address

Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144

Country

Australia

Phone

+61 3 9508 3428

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12620	Study protocol			[email protected]
12621	Statistical 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.

Trial Review

Documents added manually

Documents added automatically