Addressing Disparities in Lupus Care Through an Integrated Care Management Program

NCT03915652 | Completed Results

• 1 other identifier: IRB 2019P000638
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

minority health; prevention; vaccine; behavior; women's health; autoimmune; intervention; survey; QI/QA; outcomes (health services/delivery)

Outcome Measures

Primary Outcomes (3)

• Lupus-related Appointment Nonadherence

  Mean change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations

  Mean change from 12 months prior to intervention and the 12 months during the intervention

• Composite Measure of Acute Care Utilization

  Mean change in the number of ED visits plus number of hospitalizations

  Mean change from 12 months prior to intervention and the 12 months during the intervention

• Quality of Lupus Care: SLE Quality Metric Scoring System for Adults

  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).

  Percent of quality metrics remaining at 12 months

Secondary Outcomes (7)

• Medication Adherence Self-Report Inventory (MASRI)

  Mean change from baseline to 12 months after the start of the intervention.

• Beliefs About Medications Survey

  Mean change from baseline compared to 12 months after the start of the intervention

• Systemic Lupus Activity Questionnaire (SLAQ)

  Mean change from baseline compared to 12 months after the start of the intervention

• Mental Health Inventory-5 (MHI-5)

  Mean change from baseline compared to 12 months after the start of the intervention

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Short Form

  Mean change from baseline compared to 12 months after the start of the intervention

Study Arms (2)

Rheum iCMP Wave 1

EXPERIMENTAL

20 patients enrolled immediately in Rheum iCMP

Behavioral: Rheum iCMP

Rheum iCMP Wave 2

EXPERIMENTAL

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

Behavioral: Rheum iCMP

Interventions

Rheum iCMP BEHAVIORAL

Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.

Rheum iCMP Wave 1; Rheum iCMP Wave 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English or Spanish speaker

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Partners HealthCare: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Behavior

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

A small percentage of participants returned their baseline and follow-up surveys which will limit interpretability of secondary outcome data. Primary outcomes came from chart review data and therefore this is complete and interpretable for the participants who did not withdraw.

Results Point of Contact

• Title: Dr. Candace Feldman
• Organization: Brigham and Women's Hospital

cfeldman@bwh.harvard.edu

6175251035

Study Officials

• Candace H Feldman, MD, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: The investigators plan to newly enroll 40 lupus patients prospectively using a stepped wedge design starting first with 20 patients enrolled in Rheum-iCMP, and then with 20 additional patients enrolled 4 months later. For the second 20 patients, for the first 4 months, patients will receive educational material.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: April 16, 2019
• Study Start: June 21, 2019
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2025
• Last Updated: September 25, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)