Comparison of an Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material on Decision Quality, Shared Decision-Making, Patient Experience, and Functional Outcomes in Adults With Knee Osteoarthritis: A Randomized Clinical Trial

Abstract

Importance: Decision aids can help inform appropriate selection of total knee replacement (TKR) for advanced knee osteoarthritis (OA). However, few decision aids combine patient education, preference assessment, and artificial intelligence (AI) using patient-reported outcome measurement data to generate personalized estimations of outcomes to augment shared decision-making (SDM).

Objective: To assess the effect of an AI-enabled patient decision aid that includes education, preference assessment, and personalized outcome estimations (using patient-reported outcome measurements) on decision quality, patient experience, functional outcomes, and process-level outcomes among individuals with advanced knee OA considering TKR in comparison with education only.

Design, setting, and participants: This randomized clinical trial at a single US academic orthopedic practice included 129 new adult patients presenting for OA-related knee pain from March 2019 to January 2020. Data were analyzed from April to May 2020.

Intervention: Patients were randomized into a group that received a decision aid including patient education, preference assessment, and personalized outcome estimations (intervention group) or a group receiving educational material only (control group) alongside usual care.

Main outcomes and measures: The primary outcome was decision quality, measured using the Knee OA Decision Quality Instrument (K-DQI). Secondary outcomes were collaborative decision-making (assessed using the CollaboRATE survey), patient satisfaction with consultation (using a numerical rating scale), Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS JR) score, consultation time, TKR rate, and treatment concordance.

Results: A total of 69 patients in the intervention group (46 [67%] women) and 60 patients in the control group (37 [62%] women) were included in the analysis. The intervention group showed better decisional quality (K-DQI mean difference, 20.0%; SE, 3.02; 95% CI, 14.2%-26.1%; P < .001), collaborative decision-making (CollaboRATE, 8 of 69 [12%] vs 28 of 60 [47%] patients below median; P < .001), satisfaction (numerical rating scale, 9 of 65 [14%] vs 19 of 58 [33%] patients below median; P = .01), and improved functional outcomes at 4 to 6 months (mean [SE] KOOS JR, 4.9 [2.24] points higher in intervention group; 95% CI, 0.8-9.0 points; P = .02). The intervention did not significantly affect consultation time (mean [SE] difference, 2.23 [2.18] minutes; P = .31), TKR rates (16 of 69 [23%] vs 7 of 60 [12%] patients; P = .11), or treatment concordance (58 of 69 [84%] vs 44 of 60 [73%] patients; P = .19).

Conclusions and relevance: In this randomized clinical trial, an AI-enabled decision aid significantly improved decision quality, level of SDM, satisfaction, and physical limitations without significantly impacting consultation times, TKR rates, or treatment concordance in patients with knee OA considering TKR. Decision aids using a personalized, data-driven approach can enhance SDM in the management of knee OA.

Trial registration: ClinicalTrials.gov Identifier: NCT03956004.

Figure 1.. Schematic of Components of Decision Aid and Data Inputs for Artificial Intelligence/Machine Learning (AI/ML) Platform to Generate Personalized Outcomes

Schematic visualizing separate components (modules) of the decision aid provided to control and intervention group patients, including data inputs required for the AI/ML platform to generate the personalized outcomes report. BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); ED, emergency department; KOOS JR, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement; PROMIS Global-10, Patient Reported Outcome Measurement Instrumentation System Global 10. ^aBenefit defined as likelihood of experiencing at least a minimal clinically important difference in functional outcome; risk defined as the likelihood of experiencing no change in condition or being worse off after undergoing surgery. ^bComplication rate defined as estimated complication rate due to joint infection within 90 days, pulmonary embolism or death within 30 days, and pneumonia, sepsis, or acute myocardial infarction within 7 days. Likelihood of improvement in stiffness, pain, and quality of life based on KOOS JR metrics.

Figure 2.. Schematic of Patient Flow and Surgeon Flow Including Demographic, Clinical, and Process Factors and Outcome Measurements at Preconsultation, Postconsultation, and 4-to-6–Month Follow-up

Schematic visualizing a step-by-step patient flow and the surgeon flow throughout the study, the timepoints at which demographic, clinical, process, and patient outcome measures are collected. Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); ED, emergency department; GAD-2/GAD-7, Generalized Anxiety Disorder Questionnaires; K-DQI, Knee Decision Quality Instrument; KOOS JR, Knee Injury and Osteoarthritis Outcomes Survey Joint Replacement; NRS-C, Numerical Rating Scale for Satisfaction; PHQ-2/PHQ-9, Patient Health Questionnaires; PROMIS Global-10, Patient Reported Outcome Measurement Information System Global-10; TKR, total knee replacement.

Figure 3.. Study Flow Diagram

Abbreviations: BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); OA, osteoarthritis; PROMs, patient-reported outcome measurements.