Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol

Abstract

Introduction: Osteoarthritis (OA) is a major clinical and public health concern. The primary surgical treatment of knee OA is total knee replacement (TKR), a procedure that aims to alleviate pain and restore physical function. TKR is expensive, however, and based on professional guidelines, inappropriately performed in up to a third of patients. Patient-reported outcome measures (PROMs) help evaluate treatment options by quantifying health outcomes that matter to patients and can thus inform shared decision-making (SDM) between patients and health professionals.

Methods and analysis: This is a US-based 2-year, two-site hybrid type 1 study to assess clinical effectiveness and implementation of a machine learning-based patient decision aid (PDA) integrating patient-reported outcomes and clinical variables to support SDM for patients with knee OA considering TKR. Substudy 1: At one study site, a randomised controlled trial is evaluating the clinical effectiveness of the PDA and SDM process on decision quality as measured after the baseline consultation and treatment choice measured 3 and 6 months after the baseline visit among 200 patients with knee OA. Substudy 2: At a second study site, a qualitative assessment using principles of behaviour design and intervention mapping is evaluating the feasibility and acceptability of the PROMs, PDA and SDM process by interviewing seven health professionals and 25 patients before and 25 patients after PDA implementation.

Ethics and dissemination: Ethics approval has been obtained from The University of Texas at Austin Institutional Review Board (protocol number: 2018-11-0042). Informed consent will be obtained from all participants. Study results will be disseminated through conference presentations, publications and professional societies.

Trial registration number: NCT04805554.

Keywords: adult orthopaedics; health informatics; knee; orthopaedic & trauma surgery; qualitative research.

Figure 1

Process flow of patient-reported outcome measures (PROM) within the clinical pathway.

Figure 2

Outcomes collected at UT Health Austin. The Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) is a seven-item patient-reported outcome measure of knee joint-related stiffness, pain and function; interval scores range from 0 to 100, with 0 representing poorest knee health and 100 best knee health. The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 is a 10-item measure assessing health-related quality of life with items about overall physical and mental health including social connections and physical capabilities. The survey is scored using two subscores, one for physical health and one for mental health, where specific items are used for a raw score and then converted to a t-score. Population norm t-scores are 50 on each subscore; higher scores reflect better physical health but worse mental health. The Patient Health Questionnaire (PHQ) is a validated two-item or nine-item survey assessing depressive symptoms and scored categorically as none, mild, moderate, moderately severe and severe. The two-item questionnaire is deployed, and if crossing a score threshold, an additional seven questions are generated. The Generalized Anxiety Disorder Questionnaire (GAD) is a two-item or seven-item survey assessing generalised anxiety disorder and scored categorically as none, mild, moderate and severe. Similar to the PHQ, if a score threshold is crossed on the two-item form, an additional five questions are generated. The Knee Decision Quality Instrument (K-DQI) is a 16-item survey with three specific scores: a total knowledge score, a concordance score and a decision process score. For the purposes of this study, the five questions in the shared decision-making section are used. One point is scored for ‘yes’ or ‘a lot/some’. These points are summed and then divided by 5, resulting in a score from 0% to 100%, with higher scores indicating a greater level of shared decision-making. The CollaboRATE is a three-item, 10-point anchor scale measuring the level of shared decision-making in a clinical encounter. It yields a continuous score with a possible range from 0 to 100, where higher scores represent a greater degree of shared decision-making. The Decision Conflict Scale (DCS) is a 10-item survey, with each response value summed, divided by the total item number and multiplied by 25. The score ranges from 0 to 100, where 0 is no decisional conflict and 100 is the greatest decisional conflict. Finally, the Decision Regret Scale (DRS) measures distress or remorse after making a healthcare decision. The answer values are summed and converted to a 0–100 scale, where a higher score indicates more regret. BMI, body mass index; ED, emergency department; TKR, total knee replacement.