Background
Methods
Study overview and hypothesis
Study design
Study population
Study intervention
Study procedures
Screening
Inclusion criteria |
1. Females with lupus nephritis 2. Currently having a flare of lupus nephritis according to expert rheumatologist and considering change or initiation of an immunosuppressive medication for lupus nephritis (current flare) or had had flare of lupus nephritis in the past and have had experience or discussion of immunosuppressive medication for lupus nephritis who were at risk for a future flare (future flare) 3. Age 18 years or older 4. All racial/ethnic groups |
Exclusion Criteria |
1. Male patients with lupus nephritis 2. Patients with lupus but no nephritis 3. Patients having kidney flare but medication change is not considered 4. Patients with end stage renal disease on dialysis 5. Patients with a renal transplant or who are candidate for a renal transplant |
Baseline visit: procedures at initial patient visit
3-month phone vs. clinic follow-up assessment
6-month medical record follow-up assessment
Outcome measures
Co-primary outcome measures
Co-Primary outcomes/ Time of assessment | Description |
---|---|
10-item patient-reported scale for lower literacy populations with 3-level response categories | |
Concordance between patient’s values related to taking immunosuppressive drugs and patients’ decision to start immunosuppressive drugs in those with adequate knowledge about immunosuppressive drugs | |
Secondary outcomes | |
Control Preferences Scale [51]/Baseline post-intervention | 2-item patient-reported assessment of whether the decision-making concordant with patient's preference about their role |
Interpersonal Processes of Care [45]/Baseline post-intervention | 18-item patient-reported multidimensional measure of physician-patient communication |
Audiotaped Patient-physician discussion [56]/Baseline post-intervention | Active Patient Participation Coding Scheme decoding speech acts indicating patient participation and whether physician communication was patient-centered |