Journal Article

Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial

Trupin, Laura, Alarcón, Graciela S., Chatham, W. Winn, Garcia, Salvador R., Barton, Jennifer L., Rizvi, Tara, Eakin, Guy S., Street, Richard L., Reyes, Elyse, Saag, Kenneth G., Hanrahan, Leslie M., Yazdany, Jinoos, Jandali, Bochra, Sloan, Jeffrey A., Winthrop, Kevin L., Meara, Alexa, Dall’Era, Maria, Fraenkel, Liana, Green, Candace, Leong, Amye L., Singh, Jasvinder A., Raymond, Sandra C., Suarez-Almazor, Maria E., Grossman, Jennifer, Marrow, Laura, Morgan, Charity J., Caro, Brennda, Kimberly, Robert P.

2019

Overview

Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. Clinicaltrials.gov, NCT02319525.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adult / African Americans / Analysis / Arthritis / Biology and Life Sciences / Care and treatment / Choice Behavior / Clinical trials / Decision making / Decision Support Techniques / Female / Health education / Health Knowledge, Attitudes, Practice / Health Literacy / Hispanic people / Humans / Immunosuppressive agents / Immunosuppressive Agents - adverse effects / Immunosuppressive Agents - therapeutic use / Lupus / Lupus nephritis / Lupus Nephritis - drug therapy / Lupus Nephritis - ethnology / Lupus Nephritis - immunology / Medical screening / Medicine / Medicine and Health Sciences / Middle Aged / Minority & ethnic groups / Mortality / Nephritis / Patient Education as Topic / Patient Participation / Patients / Randomization / Rheumatic diseases / Risk factors / Sensitivity analysis / Social Sciences / Socioeconomics / Standard error / Statistical analysis / Supervision / Treatment Outcome / United States - epidemiology / Womens health