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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with lupus through an intensive care management program (Rheum iCMP) led by a nurse manager. The goal is to enhance regular outpatient care and reduce unnecessary emergency visits and hospital stays. Researchers will also explore social factors affecting lupus care through interviews and a photo project. Participants should have a lupus diagnosis and experience frequent hospital visits or missed doctor appointments. The trial involves two groups: one starts the program immediately, while the other joins after four months, receiving educational materials in the interim. As an unphased trial, this study offers a unique opportunity to contribute to innovative lupus care solutions and potentially improve participants' own care experiences.

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.

What prior data suggests that this care management program is safe for lupus patients?

Research has shown that the Rheum iCMP, a nurse-led program for managing lupus, is generally safe and well-tolerated. Studies have found that participants in similar programs experienced fewer emergency room visits and hospital stays. This suggests the program may help control lupus symptoms without causing major side effects.

Trained nurses run the program, providing personalized care and support. Although specific information on negative effects is not available, the program's aim to reduce hospital visits indicates a design focused on safely improving patient health. Overall, the Rheum iCMP appears to be a safe choice for lupus patients seeking better care management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Rheum iCMP treatment for lupus because it integrates comprehensive care management in a way that current options do not. Unlike typical lupus treatments, which often involve medications like corticosteroids and immunosuppressants to manage symptoms, Rheum iCMP focuses on providing personalized care and education. This approach not only addresses the immediate physical symptoms but also empowers patients through education, potentially leading to better long-term management of the disease. By tailoring treatment and offering educational support, Rheum iCMP aims to improve both health outcomes and quality of life for lupus patients.

What evidence suggests that this trial's treatments could be effective for lupus?

Research has shown that the Rheum iCMP (Integrated Care Management Program) is highly effective for people with lupus. In this trial, participants will join one of two waves of the Rheum iCMP. One study found that this nurse-led program significantly reduced emergency room visits and hospital stays for high-risk patients. Patients experienced fewer avoidable visits, indicating improved condition management. Another study revealed that the program identified social factors affecting lupus care, leading to more personalized support. Overall, the Rheum iCMP offers significant benefits by enhancing lupus management and reducing unnecessary hospital visits. ^{1 2 3 5 6}

Who Is on the Research Team?

Candace H Feldman, MD, ScD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35043589/

The Impact of an Integrated Care Management Program on ... A nurse-led iCMP was effective at decreasing the rate of all ED visits and potentially avoidable ED visits and hospitalizations among high-risk patients with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03915652?term=Lupus&aggFilters=status:act&viewType=Table&rank=4&tab=results

Study Results | Addressing Disparities in Lupus Care ... Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8992467/

The Impact of an Integrated Care Management Program on ... A nurse‐led iCMP was effective at decreasing the rate of all ED visits and potentially avoidable ED visits and hospitalizations among high‐risk patients with ...

4. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/full/10.1002/acr2.11236

Use of an Integrated Care Management Program to Uncover ... We studied patients with systemic lupus erythematosus (SLE) enrolled in a nurse-led, multihospital, primary care–based integrated care management program (iCMP)

5. profiles.wustl.edu profiles.wustl.edu/en/publications/the-impact-of-an-integrated-care-management-program-on-acute-care/

The Impact of an Integrated Care Management Program on ... Results: We identified 67 iCMP enrollees with SLE and linked EHR claims data. In adjusted analyses, iCMP enrollment was associated with reduced rates of ED ...

6. withpower.com withpower.com/trial/phase-lupus-erythematosus-systemic-5-2019-e4779

Integrated Care Management for Lupus (Rheum-iCMP 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 ...