Addressing Disparities in Lupus Care Through an Integrated Care Management Program

NCT ID: NCT03915652

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-21
• Study Completion Date: 2025-07-20

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.

Detailed Description

The aim of this study is to determine whether an intensive care management program for high-risk lupus patients (Rheum-iCMP, modeled after the highly successful BWH iCMP for primary care patients) reduces acute care utilization (emergency department (ED) visits, hospitalizations), improves rheumatology clinic appointment attendance, and ultimately improves quality of lupus care in this group. 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.

The investigators plan to identify high-risk lupus patients in the Partners' risk contract (Medicaid, Medicare and certain commercial insurances) with BWH primary care physicians (PCPs) from three sources. First, the investigators will use the BWH Lupus Registry, which is updated regularly and includes lupus patients actively receiving care at BWH. Second, the investigators will identify lupus patients via Partners electronic medical record (EMR) using our validated lupus algorithm and look specifically at those receiving primary care within the BWH system. The investigators will link both BWH Lupus Registry patients and patients meeting our algorithm to claims data through the Population Health Repository. The investigators will then identify patients with increased healthcare utilization, including ED visits and/or hospitalizations during the preceding 3 years, and who are at risk for avoidable outcomes (rheumatology appointment no-shows/same-day cancellations within the same period). The investigators will also apply the Partners' Center for Population Health high-risk algorithm to both cohorts to identify additional high-risk patients. The investigators will then reach out to the identified patients' PCPs or their rheumatologists for approval to send a study invitation to patients or asking physicians to introduce the study to their patients with a fact sheet. Third, the investigators will ask rheumatologists to refer lupus patients who might benefit from Rheum-iCMP, since a similar referral system has been successful within BWH-wide iCMP.

The investigators plan to newly enroll 40 lupus patients aged ≥18 years old, both male and female, English-speaking, and who receive their primary care at BWH 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 about lupus on a monthly basis. The investigators will invite these 40 patients to also participate in a semi-structured interview that includes asking participants ahead of time to take 10-15 photographs (with a disposable camera the investigators will provide) of their neighborhoods and homes, in order to begin a conversation about the social determinants that contribute to their care-seeking behaviors. Participants will then sit with a moderator for a ~60-90 minute semi-structured, in-depth photo-elicitation interview. Participants will be asked to 1) select the photographs for discussion, 2) contextualize each image and tell a story, 3) describe what is really happening and how it relates to their life and 4) propose suggestions for what can be done to improve any barriers described. The elicitation interviews will be audio-recorded, transcribed verbatim, and entered into Dedoose for analysis. Participation in the photographs/interview is not a requirement of being a part of Rheum-iCMP.

In addition to these 40 newly enrolled patients, the investigators expect that 100 additional adult lupus patients within the Partners system are already enrolled in BWH iCMP. Among these patients, the investigators plan to examine EMR and claims data pre and post iCMP enrollment as an observational study looking at differences in utilization. However, the investigators do not plan to ask for survey completion for this population since this iCMP program is considered standard of care and these patients are already a part of it. Because the investigators do not feel that this will involve more than minimal risk and because it would not be feasible, the investigators do not plan to consent these individuals to allow us to examine their medical records.

The investigators will compare lupus-related quality metrics, rheumatology appointment attendance, and acute care use 12 months after enrollment in rheum-iCMP as compared to 12 months before enrollment in rheum-iCMP. The investigators will collect surveys at 12 months after enrollment in rheum-iCMP. For individuals who unenrolled before the end of the 12-month study period, we will stop the chart review at the date of unenrollment. The investigators will also examine EMR and claims data when available prior to the rheum-iCMP and then for the subsequent 12-24 months during and following rheum-iCMP. For the lupus patients who are already enrolled in BWH iCMP, the investigators will separately compare measures extractable from EMRs and claims pre-iCMP, during iCMP but pre-lupus-specific iCMP nurse training, and during Rheum-iCMP (post- nurse training) for N=100. These data are observational/non-experimental and distinct from the pilot trial intervention and thus cannot be combined and will be analyzed separately.

During the intervention period, our project coordinator will set up a sustainable EPIC system for tracking appointment no-shows and SLE quality metrics (e.g. lab monitoring, contraceptive use). The investigators will collect the following surveys: medication adherence and medication beliefs using the MASRI survey and the Beliefs about Medications scale, lupus disease activity using SLAQ, mental health using the MHI-5, social determinants of health using the Partners Healthcare Social Determinants of Health (SDH) Survey, global health assessment using the PROMIS global health scale short form, and racial discrimination using the Everyday Discrimination Scale. The investigators will also collect baseline demographics information via a demographics survey. The investigators will determine acute care utilization (e.g. ED visits, hospitalizations) using partners risk contract claims data. The investigators will also use surveys at 12 months after rheum-iCMP enrollment to assess patient, iCMP nurse, and MD satisfaction. Surveys will be collected at outpatient appointments or via mail. For longer term quality metrics 12-24 months past the intervention period, the investigators will work with the Center for Population Health's team to set up a tracking system that has Partners-wide claims data linked with EMRs. For the 100 patients already enrolled in the iCMP intervention, the investigators assess changes in acute care use (ED visits and hospitalizations) and appointment no shows however this is an observational separate study and will not be compared to data from the newly enrolled patients. The investigators will also collect these data for the 40 newly enrolled patients, which will be analyzed separately as the intervention is different.

This is a pilot study. One of our primary measures is to reduce ambulatory rheumatology care no-show rates for the highest risk patients. The investigators estimate that the no-show rate is about 70% and the aim of this study is to reduce this rate to 20%. The investigators would need a total of 40 patients (20 in each arm) to have 80% power to detect this difference, which is why the target enrollment for new patients in Rheum-iCMP is 40.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Rheum iCMP Wave 1

20 patients enrolled immediately in Rheum iCMP

Group Type: EXPERIMENTAL

Rheum iCMP

Intervention Type: 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 2

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 Type: EXPERIMENTAL

Rheum iCMP

Intervention Type: 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.

Interventions

Rheum iCMP

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Partners HealthCare

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Candace Hillary Feldman, MD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Candace H Feldman, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB 2019P000638

Identifier Type: -

Identifier Source: org_study_id