Integrated Care Management for Lupus

(Rheum-iCMP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Non-English or Spanish speaker

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this lupus trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Integrated Care Management for Lupus treatment generally safe for humans?

The safety data for treatments similar to Integrated Care Management for Lupus, like belimumab and anifrolumab, show that while they can improve outcomes for lupus patients, they may increase the risk of infections such as herpes zoster and respiratory infections. These risks are more common in patients with active lupus nephritis, and specific precautions like vaccinations may be needed. ^{1 2 3 4 5}

How is the Rheum iCMP treatment for lupus different from other treatments?

Rheum iCMP is unique because it is a nurse-led integrated care management program that focuses on coordinating care for lupus patients at high risk for frequent hospital visits and missed appointments. Unlike traditional treatments that primarily focus on medication, this program addresses social determinants of health, such as food insecurity and housing instability, to improve overall patient outcomes. ^{6 7 8 9 10}

Research Team

Candace H Feldman, MD, ScD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for lupus patients at Brigham and Women's Hospital who've had a hospital visit or missed an appointment in the last 3 years, get their primary care there, and meet specific lupus diagnosis criteria. It's not open to those who don't speak English or Spanish.

Inclusion Criteria

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

You have been diagnosed with systemic lupus erythematosus (SLE) by a rheumatologist, based on specific criteria set by the American College of Rheumatology.

Exclusion Criteria

Non-English or Spanish speaker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are enrolled in the Rheum-iCMP program, with the first wave starting immediately and the second wave starting after 4 months. The second wave receives monthly educational materials during the first 4 months.

12 months

Monthly educational materials for Wave 2

Follow-up

Participants are monitored for changes in lupus-related care metrics, acute care utilization, and social determinants of health.

12-24 months

Treatment Details

Interventions

• Rheum iCMP

Trial Overview The study tests an intensive care management program (Rheum iCMP) involving a nurse manager for high-risk lupus patients. The goal is to see if it improves regular outpatient care and reduces unnecessary emergency visits and hospital stays.

Participant Groups

Group I: Rheum iCMP Wave 2 Experimental Treatment 1 Intervention

20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months

Group II: Rheum iCMP Wave 1 Experimental Treatment 1 Intervention

20 patients enrolled immediately in Rheum iCMP

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Partners HealthCare

Collaborator

Trials

15

Recruited

55,000+

Findings from Research

In a study involving 364 patients with systemic lupus erythematosus (SLE), long-term treatment with belimumab combined with standard therapy demonstrated a stable or declining incidence of adverse events over 4 years, indicating a favorable safety profile.

The most common side effects were mild, such as arthralgia and upper respiratory infections, and serious infusion reactions were rare, suggesting that belimumab can be safely administered for extended periods in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Merrill, JT., Ginzler, EM., Wallace, DJ., et al.[2013]

A 5-year review of Morbidity and Mortality Conferences in the Division of Rheumatology at SickKids identified 83 reported cases, with the majority related to miscommunication (34.9%) and treatment/test/procedure issues (22.9%).

The review led to 89 recommendations for system improvements, emphasizing that increased reporting of adverse events can enhance patient safety and healthcare quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trying to improve care: the Morbidity and Mortality Conference in a division of rheumatology. Batthish, M., Tse, SM., Feldman, BM., et al.[2014]

The DANBIO database captured 20 times more adverse events related to biological agents than the Danish Medicines Agency, highlighting its effectiveness in monitoring patient safety.

Infections and hypersensitivity reactions were the most common adverse events, with older age, longer disease duration, and a higher number of previous DMARD treatments identified as risk factors for bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). Hetland, ML., Unkerskov, J., Ravn, T., et al.[2019]

Anifrolumab 300 mg significantly improved treatment responses in patients with active systemic lupus erythematosus (SLE), showing higher BICLA, SRI7, and SRI8 responses compared to placebo in a meta-analysis of three randomized controlled trials involving 459 patients.

While anifrolumab was effective, it also increased the incidence of herpes zoster infections compared to placebo, highlighting a safety concern despite a lower rate of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab for the treatment of active systemic lupus erythematosus: a meta-analysis of randomized controlled trials. Lee, YH., Song, GG.[2021]

The CALLS study, involving 30 participants, showed that a 12-week intervention with patient navigators significantly improved perceived self-efficacy in managing lupus compared to usual care.

While the intervention group experienced a slight decrease in disease flare scores, this change was not statistically significant, indicating that further research is needed to confirm long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Care-coordination Approach to Learning Lupus Self-Management: a patient navigator intervention for systemic lupus inpatients. White, AA., Ba, A., Faith, TD., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. [2013]

2. Canada pubmed.ncbi.nlm.nih.gov

Trying to improve care: the Morbidity and Mortality Conference in a division of rheumatology. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Biological drugs for systemic lupus erythematosus or active lupus nephritis and rates of infectious complications. Evidence from large clinical trials. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Anifrolumab for the treatment of active systemic lupus erythematosus: a meta-analysis of randomized controlled trials. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The Care-coordination Approach to Learning Lupus Self-Management: a patient navigator intervention for systemic lupus inpatients. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Impact of an Integrated Care Management Program on Acute Care Use and Outpatient Appointment Attendance Among High-Risk Patients With Lupus. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The patient's perspective: are quality of life and disease burden a possible treatment target in systemic lupus erythematosus? [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Use of an Integrated Care Management Program to Uncover and Address Social Determinants of Health for Individuals With Lupus. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Autoimmune Conditions: Systemic Lupus Erythematosus. [2020]