Patient outcomes from implementing a shared decision-making aid for systemic lupus erythematosus: a prospective implementation study.

Background: Data on patient decision making for people with systemic lupus erythematosus (SLE) are scarce. We previously showed that an evidence-based SLE patient decision aid was more effective than the SLE information pamphlet provided by the American College of Rheumatology in reducing decisional conflict for the choice of immunosuppressive medications in women with lupus nephritis, with higher acceptability and feasibility. The aim of this study was to assess patient outcomes from the implementation of this SLE patient decision aid on disease management in people with SLE.

Methods: This prospective implementation study was done in 15 geographically diverse rheumatology clinics across the USA. Adults aged 18 years or older with a diagnosis of SLE identified based on a medical record review were included. There were no exclusion criteria. Participants were invited to view the computerised SLE patient decision aid, provided through a touchscreen tablet, a website, or a smartphone app during a regular clinic visit with their rheumatologist at baseline (viewing at follow-up visits was optional). Participants viewed either the full or abbreviated (lite) version, based on SLE disease activity and treatment, as recommended by their rheumatologist. Participants completed validated computerised surveys at each of the baseline, 3-month, and 6-month clinic visits on touchpad computers or their mobile phone (depending on patient preference). These surveys included questions related to patient decisional conflict, shared decision making, patient-physician communication, and perceived acceptability and feasibility of the decision aid. The main outcome of this study was to assess the impact of the SLE patient decision aid (both full and lite versions) on patient decisional conflict, shared decision making, patient-provider communication, and perceived acceptability and feasibility. The study had a multistakeholder committee that included people with lived experience of SLE. This study was registered at ClinicalTrials.gov, NCT03735238.

Findings: Between May 23, 2019, and Dec 12, 2023, 2005 patients with SLE were assessed for eligibility and 1895 were included in the study. Study participants had a mean age of 44·7 years (SD 14·4); of the 1855 respondents with data on sex, 1731 (93·3%) were female and 124 (6·7%) were male; of the 1832 respondents with data on race, 827 (45·1%) were African American. Patient outcomes were either good or excellent at the baseline visit after viewing the SLE patient decision aid, including preparation for decision making. The mean Low Literacy Decisional Conflict Scale score was low at 19·5 (SD 23·8); 1351 (82·8%) of 1631 participants matched with their preferred role versus their actual role in treatment decision making (using the control preferences scale); the mean CollaboRATE score was 25·2 (SD 4·1; for patient involvement in shared decision making); the mean patient-provider communication process score was 82·2 (SD 9·3); and 1510 (81·4%) of 1855 participants found the decision aid to be balanced for the information on immunosuppressive drugs versus glucocorticoids. Each outcome score remained consistent at follow-up visits at 3 and 6 months.

Interpretation: Patient outcomes, including shared decision making and perceived acceptability and feasibility of the decision aid, were either good or excellent and persisted during the implementation of a decision aid for patients with SLE. The decision aid is suitable for all SLE manifestations and is freely available as a smartphone app (ManageMyLupus).

Funding: Patient-Centered Outcomes Research Institute.