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

BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02319525.

A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis.

OBJECTIVE: The objective of this study was to assess the efficacy of self-administered patient educational tools in improving knowledge and behaviors for the management of knee osteoarthritis. METHODS: We conducted a randomized clinical trial in patients with knee osteoarthritis to assess the efficacy of providing a video for entertainment education, in combination with two booklets, compared with providing the booklets alone. We evaluated changes in scores on a patient knowledge questionnaire, the Decisional Conflict Scale, the Arthritis Self-Efficacy Scale, and the Effective Consumer Scale between baseline and same day, 3 months, and 6 months post intervention. We used linear regression models to explore associations between demographic characteristics and outcomes, testing for interactions. RESULTS: Two hundred nineteen participants were randomly assigned to receive the video + booklets (n = 109) or the booklets alone (n = 110). The mean age of participants was 64.6 (±8.3) years. At 6 months, statistically significant improvements were observed in knowledge and decisional conflict scores for both groups, and statistically significant improvements in the behavior to participate in their health care were observed in the video + booklets group. The video + booklets group was more knowledgeable immediately post intervention than the booklet group (mean difference 0.39 [95% confidence interval 0.02-0.76]). No other significant changes in outcomes were observed at 6 months between the two groups. The video + booklets combination was associated with decreased decisional conflict in Spanish speakers and increased self-efficacy in those with less than a high school education. CONCLUSION: Although both education strategies were associated with improved knowledge and reduced decisional conflict at 6 months, receiving the video + booklets in combination, compared with receiving the booklets alone, proved to be more effective in changing behaviors and appeared to have some advantages for Spanish speakers and those who were less educated.

Randomized Controlled Trial of Patient Education Tools for Patients With Rheumatoid Arthritis.

OBJECTIVE: The present study was undertaken to evaluate the efficacy of 2 educational tools for patients with rheumatoid arthritis (RA) by comparing a newly developed video tool, including storylines and testimonials, combined with a written booklet to the same written booklet alone. METHODS: We conducted a randomized controlled trial. Our primary outcome was disease knowledge. Secondary outcomes were decisional conflict, self-efficacy, effective health care management, and satisfaction. Outcomes were measured before and after reviewing the materials, and 3 and 6 months later. Linear mixed-effects models were performed to evaluate changes over time. RESULTS: In total, 221 participants received an educational video and booklet (n = 111) or a booklet alone (n = 110). The mean age was 50.8 years, mean disease duration was 4.8 years, 85% were female, and 24% had limited health literacy levels. Within groups, most outcomes improved between baseline and follow-up, but there were no statistically significant differences across groups. Patients receiving the video and booklet were more likely than those receiving the booklet alone to rate the presentation as excellent for providing information about the impact of RA, medication options, evidence about medications, benefits of medication, and self-care options. Factors significantly associated with greater improvements in knowledge and decisional conflict from baseline to 6 months included limited health literacy, lower educational level, and shorter disease duration. CONCLUSION: Regardless of the delivery method, outcomes were improved up to 6 months after educational materials were delivered. Our findings support the implementation of self-administered educational materials in clinical settings, as they can result in sustained improvements in disease knowledge and decisional conflict.