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

Abstract

Background: While 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.

Methods: This is a pragmatic, randomised controlled trial conducted at one site in Alberta, Canada. Adults over the age of 30 years, 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.

Discussion: This 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.

Keywords: Decision quality; Osteoarthritis; Patient-reported outcome measures; Total knee arthroplasty.

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the University of Calgary and University of British Columbia Research Ethics Boards. Any modifications to this protocol that impact study procedures or analysis will result in an amendment to the protocol and ethics application. All participants are asked to sign an informed consent form prior to being included in the study.

Consent for publication

Not applicable.

Competing interests

All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: support from the EuroQol group for funding the research (NB and DAM); no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. Consulting fees from Washington State Health Care Authority for providing training in the use of the International Patient Decision Aid Standards that the healthcare authority are using for certifying patient decision aids from January to June 2017 (DS), membership of the EuroQol research group (NB).

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Figures

Fig. 1

Routine practice and study-specific procedures. PHN: Personal Health Number; h: hip; k: knee; l: left; r: right; QoL: Quality of Life; ABJHI: Alberta Bone and Joint Health Institute; SDM: Shared Decision Making

Fig. 2

Overview of PROM-based decision aid. EQ-5D: EuroQol Questionnaire 5-Dimensions; HK-DQI: Hip and Knee Decision Quality Instrument; CPS: Control Preferences Scale