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Addressing Disparities in Lupus Care Through an Integrated Care Management Program
NA trial testing Rheum iCMP in Systemic Lupus Erythematosus in 35 participants. Completed in 20 July 2025.
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 35 |
| Start date | 21 June 2019 |
| Primary completion | 20 July 2022 |
| Estimated completion | 20 July 2025 |
| Sites | 1 location across United States |
Brigham and Women's Hospital
18 and older, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 6.2 | ± 7.4 |
| Rheum iCMP Wave 2 | 5.2 | ± 5.6 |
Mean change in the number of ED visits plus number of hospitalizations
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 1.29 | ± 2.54 |
| Rheum iCMP Wave 2 | 1.17 | ± 1.90 |
Percent of quality metrics from the SLE Quality Metric Scoring System for Adults remaining from baseline 12 months after the start of the intervention. The percent of needs remaining at 12 months was determined and the mean (SD) percent of remaining needs was calculated by arm. Percentages can range from 0-100, with 100 meaning that more quality metrics were not completed (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 64 | ± 32 |
| Rheum iCMP Wave 2 | 53 | ± 41 |
Mean change in MASRI score (for lupus medications) from baseline to 12 months. Score range is 0-100. Higher scores indicate greater adherence (on a scale from 0 to 100, 100 indicating a person's rating of perfect adherence).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 65 | ± 49.5 |
| Rheum iCMP Wave 2 | 98.8 | ± 2.5 |
Mean change in Beliefs About Medications score (for lupus medications) from baseline to 12 months after the start of the intervention. Score range is 5-25. Higher scores indicate a worse outcome (higher scores indicate more negative feelings about lupus medications).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 2.13 | ± 1.14 |
| Rheum iCMP Wave 2 | 1.4 | ± 0.43 |
Mean change in patient-reported lupus disease activity from baseline to 12 months using the SLAQ score. Score range is 0-46. Higher scores indicate a worse outcome (higher scores indicate more lupus disease activity).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 11 | ± 7.07 |
| Rheum iCMP Wave 2 | 14.3 | ± 4.93 |
Mean change in depressive or anxious symptoms from baseline to 12 months using the MHI-5 survey. Score range is 0-100. Higher scores indicate a better outcome (higher scores indicate better mental health).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 48 | ± 17 |
| Rheum iCMP Wave 2 | 58 | ± 14.1 |
Mean change in global health from baseline to 12 months using the PROMIS global health scale short form. Score range is 9-45. Higher scores indicate a better outcome (higher scores indicate improved global health and well-being).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 39 | ± 2.76 |
| Rheum iCMP Wave 2 | 39.8 | ± 4.27 |
Percent of social determinants of health (SDoH)-related needs at 12 months from baseline using the SDoH Survey. The survey range is 0-8 and the percent of remaining needs is 0-100 with 100 meaning that all of the needs remain (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 2.33 | ± 1.15 |
| Rheum iCMP Wave 2 | 1 | ± 1.41 |
Mean change in daily discrimination encountered from baseline to 12 months using the Everyday Discrimination Scale. Score range is 0-40. Higher scores indicate a worse outcome (higher scores indicate a greater amount of discrimination encountered).
| Group | Value | 95% CI |
|---|---|---|
| Rheum iCMP Wave 1 | 1.33 | ± 1.15 |
| Rheum iCMP Wave 2 | 1.75 | ± 2.87 |
The aim of this study is to identify lupus patients receiving care at Brigham and Women's Hospital (BWH) who are at high risk for potentially avoidable acute care utilization, inconsistent ambulatory care use, and adverse outcomes. The investigators will invite high-risk lupus patients to participate in an intensive care management program with a nurse manager, and will determine whether this program improves receipt of high quality sustained outpatient care and reduces avoidable emergency department visits and hospitalizations. The investigators will also study the social determinants that contribute to acute care use and avoidable outcomes among lupus patients using semi-structured interviews and a photovoice method.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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