Addressing Disparities in Lupus Care Through an Integrated Care Management Program

Systemic Lupus Erythematosus Clinical Trial

— Rheum-iCMP  

Official title:

Addressing Disparities in Lupus Care Through an Integrated Care Management Program (Rheum-iCMP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03915652
• Other study ID #: IRB 2019P000638
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

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. The investigators will also collect these data for the 40 newly enrolled patients.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: December 30, 2023
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Partners HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lupus-related appointment nonadherence	Change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations	12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention
Primary	Composite measure of acute care utilization	Change in the number of ED visits plus number of hospitalizations	12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention
Primary	Quality of Lupus Care: SLE Quality Metric Scoring System for Adults	Change in quality of lupus care as measured by the SLE Quality Metric Scoring System for Adults. This includes 9 subscales within this scoring system (general SLE preventive care, immunizations, cancer screening, infectious screening prior to initiation of immunosuppression, screening for cardiovascular disease, laboratory monitoring for SLE disease activity and renal involvement, reducing morbidity due to medications, reproductive health, and management of comorbid antiphospholipid syndrome). The score for each subscale is calculated as the number of yes answers divided by the number of applicable questions, multiplied by 100 to convert to a percentage. Score range 0% to 100% for each subscale. Higher scores indicate a better outcome (higher scores indicate higher quality of lupus care). The investigators will look both at individual subscale scores and a mean (SD) score across all subscales.	12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention
Secondary	Medication Adherence Self-Report Inventory (MASRI)	Change in MASRI score (for lupus medications) from baseline to 12 months. Score range is 0-12. Higher scores indicate a worse outcome (higher scores indicate less adherence to lupus medications).	Baseline compared to 12 months after the start of the intervention
Secondary	Beliefs About Medications Survey	Change in Beliefs About Medications score (for lupus medications) from baseline to 12 months. Score range is 5-25. Higher scores indicate a worse outcome (higher scores indicate more negative feelings about lupus medications).	Baseline compared to 12 months after the start of the intervention
Secondary	Systemic Lupus Activity Questionnaire (SLAQ)	Change in patient-reported lupus disease activity from baseline to 12 months using the SLAQ score. Score range is 0-46. Higher scores indicate a worse outcome (higher scores indicate more lupus disease activity).	Baseline compared to 12 months after the start of the intervention
Secondary	Mental Health Inventory-5 (MHI-5)	Change in depressive or anxious symptoms from baseline to 12 months using the MHI-5 survey. Score range is 0-100. Higher scores indicate a better outcome (higher scores indicate better mental health).	Baseline compared to 12 months after the start of the intervention
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Short Form	Change in global health from baseline to 12 months using the PROMIS global health scale short form. Score range is 9-45. Higher scores indicate a better outcome (higher scores indicate improved global health and well-being).	Baseline compared to 12 months after the start of the intervention
Secondary	Partners Healthcare Social Determinants of Health (SDH) Survey	Change in social determinants of health from baseline to 12 months using the Partners Healthcare SDH Survey. There is no numerical scoring system for this survey. The investigators are looking at the change in percentage of questions answered with "yes" between baseline and 12 months for each participant.	Baseline compared to 12 months after the start of the intervention
Secondary	Everyday Discrimination Scale	Change in daily discrimination encountered from baseline to 12 months using the Everday Discrimination Scale. Score range is 0-40. Higher scores indicate a worse outcome (higher scores indicate a greater amount of discrimination encountered).	Baseline compared to 12 months after the start of the intervention