BACKGROUND/OBJECTIVE: Systemic lupus erythematosus (SLE) is a rare and sometimes fatal disease. Lupus nephritis inflammation of the kidney is a devastating complication of SLE and is often more common in racial/ethnic minorities. Immunosuppressive drugs can effectively treat lupus nephritis, but patients may be reluctant to use them due to concerns about side effects and lack of understanding of their potential benefits. We assessed whether a web-based, individualized, culturally tailored, computerized patient decision aid can improve decision-making regarding using immunosuppressive drugs in women with lupus nephritis.
We developed a patient decision aid for immunosuppressive medication decision-making based on formative work with 52 lupus nephritis patients (predominantly racial/ethnic minorities with low socioeconomic status) and systematic review, meta-analyses, and network meta-analyses. In a 6-month randomized controlled trial at 4 US centers, we recruited adult women, largely racial/ethnic minorities with low socioeconomic status, who were making decisions about starting or maintaining treatment of lupus nephritis flares, or who had a history of lupus nephritis flares and were at risk of future flares. Patients were randomized during a clinic visit to receive a patient decision aid on a tablet computer or a standard American College of Rheumatology (ACR) pamphlet that provided information about lupus and its treatment, including the use of immunosuppressive drugs. The study was conducted during clinic visits and outcome assessments occurred immediately after the intervention was administered. Coprimary outcomes were a change in decisional conflict assessed with a low literacy-version Decisional Conflict Scale (0-100; the higher the score, the more conflict was present) and the proportion with an informed choice regarding immunosuppressive drugs (concordance of the patients' values and their choice for or against immunosuppressives based on an adequate knowledge of the drugs). Secondary outcomes included (1) the concordance between a patient's desired and actual role in immunosuppressive drugs decision-making using the control preference scale, (2) the patient perception of patient-physician communication and care processes using the Interpersonal Process of Care-Short Form (IPC-SF), and (3) the assessment of patient-physician communication by assessing the audio-taped physician-patient conversation about therapy options.
Of the 301 women with lupus nephritis randomized, 3 patients withdrew consent and 298 received an individualized decision aid (n = 151) or the ACR pamphlet (n = 147, control arm). The mean age was 37 years, 35% had an annual income <$20 000, 36% had a high school education or less, the average health literacy score on the Short Assessment of Health Literacy was 16.8 (a score of 0-14 denotes low health literacy), 47% were African American, and 26% were Hispanic. Compared with those who received the pamphlet, patients who received the decision aid had a significantly larger reduction in decisional conflict (21.8 [SD, 30.9] vs 12.7 [SD, 24.4]; = .005). The group receiving the decision aid made informed choices regarding immunosuppressive drugs more frequently (41% vs 31%), although this did not meet statistical significance ( = .08). Sensitivity analysis that used an alternate definition of informed choice (positive vs negative values rather than the median score for values) showed that significantly more women in the decision aid group made an informed choice compared with those in the pamphlet group (50% vs 35%; = .006). We noted no statistically significant differences in the secondary outcomes of concordance in the desired vs the actual role in decision-making (94% vs 85%; = .25) or the IPC-SF scores (83.6 [SD, 7.7] vs 83.1 [SD, 7.3]; = .50). Using an audio-taped patient-physician conversation, the patient-centered communication by doctor showed a statistical trend toward significance in the decision aid vs the pamphlet group (5.1 vs 3.7; = .06).
An electronic, individualized, culturally appropriate patient decision aid was effective in reducing the decisional conflict regarding choosing immunosuppressive drugs in an ethnically and socioeconomically diverse sample of women with lupus nephritis. Future studies should investigate whether this decision aid can be further enhanced to improve its efficacy, modified for other manifestations of lupus, or provided on a mobile platform, so that patients have even easier access to it. The PCORI lupus nephritis decision aid will be available in the public domain.
