Article Text
Abstract
Background Low-value arthroscopic surgery continues to be used to treat people with degenerative knee conditions (osteoarthritis, degenerative meniscal tears, loose bodies) despite consistent evidence from placebo-controlled trials and guidelines recommending against its use. Patients and some clinicians continue to harbour misconceptions about the value of this treatment modality and clinicians identify patient expectation as one key driver of arthroscopies.
There is a substantial evidence base that indicates that patient decision aids increase knowledge and accuracy of perceptions about the benefits and harms of treatment options. They have been used to reduce the number of people choosing surgery in favour of more conservative options without adversely impacting on health outcomes but no decision aid focussing specifically on knee arthroscopy has been evaluated to date.
Objective This study aims to evaluate the effectiveness and implementation potential of a patient decision aid for knee arthroscopy. Specifically our objectives are (i) to estimate the effectiveness and safety of a patient decision aid aimed at reducing referral for consideration of arthroscopy in people with degenerative knee disease compared with usual care; and (ii) to explore barriers and facilitators to wider implementation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, in order to promote future successful implementation of the decision aid in Australia.
Methods We will conduct a two-arm RCT using an effectiveness-implementation hybrid trial design. This design evaluates the effects of a clinical intervention while also gathering information about its delivery and implementation. Restricted randomisation will be used to allocate participants with degenerative knee disease to intervention or control. Participants in the intervention group will receive a decision aid containing estimates of benefits and harms from our Cochrane review of knee arthroscopy and content consumers/patients have reported that they want included. The decision aid was refined after user testing with both patients and clinicians. Participants in both the intervention and control (‘usual care’) groups will receive an Arthritis Australia information sheet about osteoarthritis to control for the effect of receipt of information and enable participant blinding. Primary outcome is rate of referral for consideration of knee arthroscopy at 6 months post intervention. Outcome assessors will be blinded to group allocation. We will conduct surveys and semi-structured interviews with participants and organisations/practices involved in recruitment to explore factors perceived to influence wider implementation and sustainability. The trial will be registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) before enrolment of participants and has been endorsed by the ANZMUSC Clinical Trial Network indicating its high priority and quality, importance to stakeholders, and potential to improve patient outcomes.
Conclusion No decision aid focussing on knee arthroscopy has been evaluated to date. Use of a patient decision aid to address this problem is anticipated to enhance patients’ knowledge and informed choice about the benefits and harms of arthroscopy and reduce referrals for and use of arthroscopic surgery. If successful, the tool could be successfully implemented in other settings and adapted for other low-value interventions.