A Pragmatic Trial of a Shared Decision‐Making Intervention to Improve Medication Adherence and Outcomes in Systemic Lupus Erythematosus: The <scp>HCQ</scp> ‐ <scp>SAFE</scp> Study

OBJECTIVES: Hydroxychloroquine (HCQ) nonadherence in systemic lupus erythematosus (SLE) stemming from decision complexities can be improved with shared decision-making (SDM) tools clarifying benefits and harms. This study aimed to develop and evaluate HCQ-SAFE©, a pictogram-based SDM tool during SLE visits. METHODS: HCQ-SAFE was developed in English and Spanish using an iterative process with 30 patient and clinician advisors. We recruited 200 adults with SLE on HCQ across 8 clinics in 2 health systems. Implementation outcome metrics including mean feasibility ratings and time to complete intervention were collected. We examined the mean change in adherence using proportion of days covered (PDC) data and decisional conflict scale (DCS) scores post-HCQ-SAFE intervention compared to baseline using paired t-test and adjusted linear regression. RESULTS: Among 200 participants, 90% were female, 51% were White, 8% spoke Spanish, and 50% reported high-school education or less. At baseline, 62% were adherent to HCQ (PDC ≥80%) and 43% reported residual decisional conflicts (DCS ≥25). Nurses (21%), pharmacists (29%), and physicians (50%) reported high feasibility (mean = 8.5) and required 5 minutes (IQR 5-7) to complete the intervention during a visit. Among HCQ non-adherers, adjusted HCQ adherence improved by 47% (CIs: 38% - 57%). Post-intervention, only 1% of patients reported residual decisional conflicts, and mean change in DCS scores was 35 points (CIs: -30 to -39) after intervention. Findings were significant across language, education level, and clinician role (p < 0.0001). CONCLUSION: HCQ-SAFE© is a feasible SDM intervention with the potential to improve adherence and reduce decisional conflicts.