Effect of a Decision Aid on Access to Total Knee Replacement for Black Patients With Osteoarthritis of the Knee: A Randomized Clinical Trial.

Importance: Black patients with advanced osteoarthritis (OA) of the knee are significantly less likely than white patients to undergo surgery. No strategies have been proved to improve access to surgery for black patients with end-stage OA of the knee. Objective: To assess whether a decision aid improves access to total knee replacement (TKR) surgery for black patients with OA of the knee. Design, Setting, and Participants: In a randomized clinical trial, 336 eligible participants who self-identified as black and 50 years or older with chronic and frequent knee pain, a Western Ontario McMaster Universities Osteoarthritis Index score of at least 39, and radiographic evidence of OA of the knee were recruited from December 1, 2010, to May 31, 2014, at 3 medical centers. Exclusion criteria were history of major joint replacement, terminal illness, inflammatory arthritis, prosthetic leg, cognitive impairment, lack of a telephone, or contraindications to elective replacement surgery. Data were analyzed on a per-protocol and intention-to-treat (ITT) basis. Exposure: Access to a decision aid for OA of the knee, a 40-minute video that describes the risks and benefits of TKR surgery. Main Outcomes and Measures: Receipt of TKR surgery within 12 months and/or a recommendation for TKR surgery from an orthopedic surgeon within 6 months after the intervention.
Results: Among 336 patients (101 men [30.1%]; 235 women [69.9%]; mean [SD] age, 59.1 [7.2] years) randomized to the intervention or control group, 13 of 168 controls (7.7%) and 25 of 168 intervention patients (14.9%) underwent TKR within 12 months (P = .04). These changes represent a 70% increase in the TKR rate, which increased by 86% (11 of 154 [7.1%] vs 23 of 150 [15.3%]; P = .02) in the per-protocol sample. Twenty-six controls (15.5%) and 34 intervention patients (20.2%) in the ITT analysis received a recommendation for surgery within 6 months (P = .25). The difference in the surgery recommendation rate between the controls (24 of 154 [15.6%]) and the intervention group (31 of 150 [20.7%]) in the per-protocol analysis also was not statistically significant (P = .25). Adjustment for study site yielded similar results: for receipt of TKR at 12 months, adjusted ORs were 2.10 (95% CI, 1.04-4.27) for the ITT analysis and 2.39 (95% CI, 1.12-5.10) for the per-protocol analysis; for recommendation of TKR at 6 months, 1.39 (95% CI, 0.79-2.44) and 1.41 (95% CI, 0.78-2.55). Conclusions and Relevance: A decision aid increased rates of TKR among black patients. However, rates of recommendation for surgery did not differ significantly. A patient-centered counseling and educational intervention may help to address racial variations in the use of TKR for the management of end-stage OA of the knee. Trial Registration: clinicaltrials.gov Identifer: NCT01851785.

RCT Entities:   Population Interventions Outcomes