Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity

NCT05715463 | Active Not Recruiting

• 1 other identifier: 2022P003268
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Social determinants of health (SDoH), defined by the World Health Organization as "the conditions in which people are born, grow, work, live and age and the wider set of forces and systems shaping the conditions of daily life" are estimated to be responsible for nearly 90 percent of a person's health outcomes. SDoH are key contributors to racial, ethnic and socioeconomic disparities in care healthcare access and health outcomes. The goal of this clinical trial is to identify patients with inflammatory arthritis or with a systemic rheumatic condition with arthritis who may respond to the simplest and least expensive intervention to address their SDoH-related needs- a tailored list of resources, those who benefit from a community-based resource specialist to help address specific needs, and those who require a nurse-trained navigator to help both coordinate the services provided by the community-based specialist, and their medical and mental health care and needs. The main questions the clinical trial aims to answer are:

1. 1.To test the efficacy of a rheumatology clinic-based nurse navigator and community resource specialist to reduce appointment no-shows and same-day cancellations in patients with systemic rheumatic conditions with arthritis.
2. 2.To examine the cost-effectiveness of each of the different study interventions for individuals with systemic rheumatic conditions with arthritis with SDoH-related needs using questionnaires and cost-related care metrics.

Conditions

Rheumatoid Arthritis; Palindromic Arthritis; Juvenile Rheumatoid Arthritis; Ankylosing Spondylitis; Sacroiliitis; Psoriatic Arthritis; Mixed Connective Tissue Disease; Lupus; Enteropathic Arthropathies; Systemic Sclerosis; Sjogren's Syndrome; Sicca Syndrome; Inflammatory Arthritis; Undifferentiated Connective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

• Patient no-shows

  Patient no-shows will be measured through EPIC data from EDW, manual chart review and RPDR. The outcome will measure number of times that a patient has been designated 'no show' to an appointment with an ambulatory care provider.

  -12 months through +12 months

Secondary Outcomes (17)

• Reduction of Social Determinants of Health-related needs in institution-created questionnaire

  -12 months through +12 months

• Reduction of Social Determinants of Health-related needs in EHR data

  -12 months through +12 months

• Medication adherence through patient questionnaire

  0 through +12 months

• Medication adherence through medication refill data

  0 through +12 months

• Acute care use overall

  0 through +12 months

Study Arms (3)

Arm 1

OTHER

Arm 1 is the control arm which will receive the standard of care resource sheets.

Other: Resource sheets

Arm 2

EXPERIMENTAL

Arm 2 will receive the assistance of a community resource specialist (CRS)- an individual without formal medical training with community-based expertise.

Other: Community Resource Specialist

Arm 3

EXPERIMENTAL

Arm 3 will receive the assistance of a bilingual (English and Spanish) nurse patient navigator with nursing training and additional rheumatology-specific training.

Other: Nurse Navigator

Interventions

Resource sheets OTHER

Arm 1 is the control arm which will receive the standard of care resource sheets. Patients in this arm will receive cultivated resource sheets for any SDoH-related needs that they screen positive for or request additional information on.

Arm 1

Community Resource Specialist OTHER

The CRS will help guide patients to the necessary community-based resources to help address their specific SDoH needs that impact their health and their ability to access sustained, high quality medical care. This may include forms to arrange for subsidized transportation to and from medical appointments or applications for Section 8 housing. The community resource specialist will reach out to patients in Arm 2 a minimum of 2 times per month, with more interactions guided by patients needs. All outreach attempts and contacts will be documented in EPIC and in REDCap. Actions taken by the CRS will be shared with members of the patient's healthcare team as appropriate (with EPIC notes routed to the rheumatologist and primary care provider, and if indicated and relevant, a social worker, nutritionist, prior CRS, nurse or mental health provider if previously involved in the patient's care).

Arm 2

Nurse Navigator OTHER

The nurse navigator will both work with the CRS to connect the patient with community-based resources, independently connect the patient with relevant resources, and also help coordinate the patient's medical care and mental health needs. The nurse patient navigator will conduct her own needs assessment (the nurse navigator high risk assessment questionnaire at the time of the first conversation with the patient, originally developed as part of the MGB integrated care management program) and her actions will be guided by their responses. She will reach out to patients a minimum of 2 times per month with an increase in communication around patient appointments as reminders, and more frequent communication on a case-by-case basis depending on active illnesses, frequency of outpatient appointments, and needs of the patient. All outreach attempts and contact will be documented in EPIC and in REDCap and similar to the CRS, be shared via EPIC with the care team as indicated.

Arm 3

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English or Spanish-speaking
• + years of age
• diagnosis of a systemic rheumatic condition with arthritis
• + prior no-show(s) or same day cancellation(s) to an ambulatory care provider in the past year
• + social determinants of health needs on Mass General Brigham questionnaire (excluding unemployment and education)
• Receiving rheumatology care at a Mass General Hospital, Brigham and Women's Hospital or Faulkner Hospital affiliated clinic

You may not qualify if:

• Incarcerated individuals
• Indicated through our EHR that they do not want to be contacted for research
• Patients already actively enrolled in an integrated care management program through their primary care provider
• Medical complexity that requires urgent nursing involvement and thus not medically appropriate for randomization

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Juvenile; Spondylitis, Ankylosing; Sacroiliitis; Arthritis, Psoriatic; Mixed Connective Tissue Disease; Scleroderma, Systemic; Sjogren's Syndrome; Arthritis; Undifferentiated Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Candace H Feldman, MD, MPH, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This will be an adaptive intervention. After six months, Individuals who do not respond to Arm 1, as measured by no improvement in SDoH-related needs and/or an outpatient no show or same day cancellation, will increase to the Arm 2 intervention for the next 6 months (see Schema). Patients in Arm 1 who do respond will graduate and then complete a follow-up set of questionnaires at 12 months. Patients in Arm 2 or Arm 3 who adequately respond and have had their SDoH-related needs addressed will graduate and receive a follow-up set of questionnaires at 12 months. Individuals in Arm 2 who continue to have one or more no show and/or continue to have SDoH-related needs will be ramped up to Arm 3. Individuals in Arm 3 with the same scenario will remain in Arm 3 for another 6 months. Data will be collected for 12 months (at baseline, 6 and 12 months) for participants in all arms including those who graduate at 6 months, to determine if the response was sustained.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 8, 2023
• Study Start: March 1, 2023
• Primary Completion: October 14, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (1)