N/A
N=35
Addressing Disparities in Lupus Care Through an Integrated Care Management Program
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT03915652 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Lupus-related Appointment Nonadherence — 6.2; 5.2 Appointment No Shows — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rheum iCMP (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lupus-related Appointment Nonadherence |
6.2; 5.2 | 0.34 |
| PRIMARY Composite Measure of Acute Care Utilization |
1.29; 1.17 | 0.34 |
| PRIMARY Quality of Lupus Care: SLE Quality Metric Scoring System for Adults |
64; 53 | <0.001 sig |
| SECONDARY Medication Adherence Self-Report Inventory (MASRI) |
65; 98.8 | 0.51 |
| SECONDARY Beliefs About Medications Survey |
2.13; 1.4 | 0.17 |
| SECONDARY Systemic Lupus Activity Questionnaire (SLAQ) |
11; 14.3 | 0.72 |
| SECONDARY Mental Health Inventory-5 (MHI-5) |
48; 58 | 0.50 |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Short Form |
39; 39.8 | 0.01 sig |
| SECONDARY Social Determinants of Health (SDOH) Survey |
2.33; 1 | 0.77 |
| SECONDARY Everyday Discrimination Scale |
1.33; 1.75 | 0.37 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Meet at least 4 American College of Rheumatology criteria for systemic lupus erythematosus (SLE) or rheumatologist diagnosis of SLE
- Over the preceding 3 years, at least 1 hospitalization or ED visit related to lupus OR at least 1 rheumatology appointment no-show or same-day cancellation
- Receive their primary care at BWH
Exclusion Criteria
- Non-English or Spanish speaker
Data sourced from ClinicalTrials.gov (NCT03915652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.