An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial

BackgroundWhile the rates of total knee arthroplasty (TKA) continue to rise worldwide, there are concerns about whether all surgeries are appropriate. Guidelines for appropriateness suggest that patients should have realistic expectations for total knee arthroplasty (TKA), and that the patient and their surgeon should agree that the potential benefits outweigh the potential harms. The objective of this study is to evaluate whether routinely collected pre- and post-TKA patient-reported outcome measures (PROMs) could be integrated into a patient decision aid to better inform these appropriateness criteria. This randomised trial will evaluate the preliminary efficacy of a tailored PROM-based patient decision aid and surgeon report (compared to usual care) for patients considering TKA on decision quality.MethodsThis is a pragmatic, randomised controlled trial conducted at one site in Alberta, Canada. Adults over the age of 30years, who have been scheduled for a TKA consultation at the Edmonton Bone and Joint Centre with a participating surgeon, who understand, speak, and read English, and can provide informed consent, are eligible to participate. Participants will be randomised to receive a PROM-based patient decision aid and surgeon report before their surgical consultation or usual care. The decision aid will provide patients with information on their expected outcomes based on the EQ-5D-5L PROM, and these estimates are individualized based on clinical and demographic characteristics. The primary outcome of this trial is decision quality. Analysis will consider outcomes intention to treat, and feasibility outcomes for implementing the trial to routine practise.DiscussionThis patient decision aid and surgeon report intervention could contribute to improved treatment decision-making for patients considering total knee arthroplasty.Trial registration (registry and number)ClinicalTrials.gov: NCT03240913. Registered on August 1, 2017.