Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

The proposed study, a randomized controlled trial [RCT], will evaluate methods to assist
minority lupus patients (African-Americans and Hispanics) to make shared decisions for the
management of their lupus nephritis considering what is the best for them. We have developed
an individualized patient decision guide that is culturally sensitive since it was developed
solely based on the values, beliefs and preferences of minority patients. We will test the
effectiveness of individualized decision aids in African-American and Hispanic lupus
nephritis patients in a 2-arm randomized trial including 200 patients. We hypothesize that
use of decision-aid will be associated with reduction in decisional conflict and more
informed choice compared to usual care group (American College of Rheumatology [ACR] lupus
pamphlet; co-primary effectiveness outcomes), both clinically meaningful and patient-centered
outcomes. We chose the low-literacy decisional conflict scale as our primary outcome, since
it is a validated measure, and the most commonly used outcome measure in decision aids RCTs.
We use informed choice as a co-primary outcome, since this is conceptually most immediate to
the intervention. It will measure whether in those with knowledge of risks and benefits of
immunosuppressive drugs, patient values are concordant with their choice of immunosuppressive
drug. Secondary outcomes include patient involvement in decision-making (concordance on
control preference scale) and patient-physician communication (Interpersonal Processes of
Care (IPC) score and analysis of audiotaped physician-patient Interaction (using the Active
Patient Participation Coding Scheme (APPC)). Since we planned to recruit patients with
current lupus nephritis flare (making current decision for an immunosuppressive drug) and
with past lupus nephritis flares (making the same decision for a future lupus nephritis
flare), two secondary outcomes (control preference scale for concordance of preferred and
real role in deciding about immunosuppressive drugs and the audiotaped physician-patient
interaction about immunosuppressive drugs) will be analyzed only in patients with current
lupus nephritis flare, a subset of the entire cohort.

Inclusion Criteria:

- adult female lupus nephritis patients, currently having a flare of lupus nephritis and
considering change or initiation of an immunosuppressive medication (current flare) or
had had flare of lupus nephritis in the past and at risk for a future lupus nephritis
flare (future flare)

Exclusion Criteria:

- male; lupus but no lupus nephritis; change in lupus immunosuppressive treatment
already made for current flare; end stage renal disease on dialysis; renal transplant
or candidate for a renal transplant