Lupus & antiphospholipid syndrome

A Pragmatic Trial of a Shared Decision‐Making Intervention to Improve Medication Adherence and Outcomes in Systemic Lupus Erythematosus: The Hydroxychloroquine (HCQ) ‐ SAFE Study

Arthritis RheumatolPublished Pragmatic single-group pre–post trial

Authors' conclusion

HCQ-SAFE is a feasible SDM intervention with the potential to improve adherence and reduce decisional conflicts.

Study context

Population
Adults with systemic lupus erythematosus (SLE) on HCQ, eight clinics in two health systems90% female
Participants
200 adults
Comparison
Post-HCQ-SAFE intervention vs baseline
Outcome
Mean change in HCQ adherence (proportion of days covered) and Decisional Conflict Scale scores post-intervention vs baseline
Methodological detailspre–post (intervention vs baseline), multicentre (eight clinics in two health systems), paired t-test and adjusted linear regression, HCQ-SAFE developed in English and Spanish using an iterative process with 30 patient and clinician advisers
  • Pre–post (intervention vs baseline)
  • Multicentre (eight clinics in two health systems)
  • Paired t-test and adjusted linear regression
  • HCQ-SAFE developed in English and Spanish using an iterative process with 30 patient and clinician advisers

Main finding

As reported in the abstract

Change in HCQ adherence (proportion of days covered (PDC)) among HCQ nonadherers, adjusted

Among HCQ nonadherers, adjusted HCQ adherence improved by

47%

95% CI 38–57

Further findings

Implementation: feasibility and time to complete intervention

Feasibility rating (nurses 21%, pharmacists 29%, physicians 50%), mean
8.5
Time to complete intervention during a visit, minutes (IQR 5-7)
five

Original publication

A Pragmatic Trial of a Shared Decision‐Making Intervention to Improve Medication Adherence and Outcomes in Systemic Lupus Erythematosus: The HCQ ‐ SAFE Study. Arthritis Rheumatol. Published 18 May 2026. doi:10.1002/art.70223

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