RecruitingACTRN12622000204741

DECIDE study - Evaluating information provided for people with knee osteoarthritis considering surgery: a randomised controlled trial

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)


Sponsor

Monash University

Enrollment

592 participants

Start Date

Aug 8, 2022

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Knee arthroscopy — keyhole surgery on the knee — has historically been offered to many people with knee osteoarthritis or meniscal tears. However, recent high-quality research has shown that for degenerative knee conditions, arthroscopy offers little to no benefit over non-surgical management such as physiotherapy, exercise, and weight management. Despite this, many patients are still referred for surgery without fully understanding all their options. The DECIDE study is testing whether providing clear, evidence-based information about osteoarthritis and its management helps people make more informed decisions about whether to have surgery. Participants will be randomly assigned to receive either standard information or a specially designed decision support resource. The study will assess whether this leads to better-informed decision-making and potentially less unnecessary surgery. You may be eligible if you are aged 45 or older, have been diagnosed by a doctor with degenerative knee disease (osteoarthritis, meniscal tears, or loose bodies causing mechanical symptoms), and have discussed or considered knee arthroscopy with a health professional. People with inflammatory arthritis, previous knee arthroscopy, bilateral total knee replacements, or who are not comfortable reading and answering questions in English are not eligible. Empowering patients with good information is a cost-effective way to improve care — and this study could help reduce thousands of unnecessary procedures each year.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 th

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.


Locations(1)

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

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ACTRN12622000204741


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