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Trial record 7 of 910 for:    Lupus

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

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ClinicalTrials.gov Identifier: NCT03915652
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Partners HealthCare
Information provided by (Responsible Party):
Candace Hillary Feldman, MD, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Behavioral: Rheum iCMP Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The investigators plan to newly enroll 30 lupus patients prospectively using a stepped wedge design starting first with 15 patients enrolled in Rheum-iCMP, and then with 15 additional patients enrolled 4 months later. For the second 15 patients, for the first 4 months, patients will receive educational material. Additionally, the investigators expect that 60 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 additional lupus-specific iCMP nurse education but patients will not be newly enrolled. Thus, there will be 2 arms for the stepped wedge design and a third group that will be already established in the iCMP program and the investigators will follow EMR and claims-based metrics pre and post rheumatology-specific nurse training. This third group will not be randomly assigned; these patients will already be a part of the established standard of care program.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Addressing Disparities in Lupus Care Through an Integrated Care Management Program (Rheum-iCMP)
Estimated Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rheum iCMP Wave 1
15 patients enrolled immediately in Rheum iCMP
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.

Experimental: Rheum iCMP Wave 2
15 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
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.

Experimental: BWH iCMP to Rheum iCMP
60 lupus patients within the Partners system who are already enrolled in BWH iCMP will have their iCMP nurse trained in lupus-specific care
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.




Primary Outcome Measures :
  1. Lupus-related appointment nonadherence [ Time Frame: 12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention ]
    Change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations

  2. Composite measure of acute care utilization [ Time Frame: 12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention ]
    Change in the number of treat-and-release ED visits plus number of hospitalizations

  3. Quality of Lupus Care: SLE Quality Metric Scoring System for Adults [ Time Frame: 12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention ]
    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.


Secondary Outcome Measures :
  1. Medication Adherence Self-Report Inventory (MASRI) [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    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).

  2. Beliefs About Medications Survey [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    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).

  3. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    Change in physician-reported lupus disease activity from baseline to 12 months using the SLEDAI score. Score range is 0-105. Higher scores indicate a worse outcome (higher scores indicate more lupus disease activity).

  4. Systemic Lupus Activity Questionnaire (SLAQ) [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    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).

  5. Mental Health Inventory-5 (MHI-5) [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    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).

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Short Form [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    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).

  7. Partners Healthcare Social Determinants of Health (SDH) Survey [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    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.

  8. Everyday Discrimination Scale [ Time Frame: Baseline compared to 12 months after the start of the intervention ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 speaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915652


Contacts
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Contact: Candace H Feldman, MD, ScD 617-525-1035 chfeldman@partners.org
Contact: Jessica N Williams, MD, MPH 617-732-5325 jwilliams62@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Candace H Feldman, MD, ScD    617-525-1035    chfeldman@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Partners HealthCare
Investigators
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Principal Investigator: Candace H Feldman, MD, ScD Brigham and Women's Hospital

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Responsible Party: Candace Hillary Feldman, MD, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03915652     History of Changes
Other Study ID Numbers: IRB 2019P000638
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Candace Hillary Feldman, MD, Brigham and Women's Hospital:
minority health
prevention
vaccine
behavior
women's health
autoimmune
intervention
survey
QI/QA
outcomes (health services/delivery)
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases