Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity

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. 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. 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.

Participants will be randomly assigned to 1 of 3 arms. In Arm 1, patients will receive a cultivated list of resources related to the needs that patients indicate on the social determinants of health questionnaire. Arm 1 is the control arm which receives the current standard of care. In Arm 2, patients will receive the assistance of a community resource specialist (CRS) - an individual without formal medical training with community-based expertise. In Arm 3, patients will receive the assistance of a nurse patient navigator with additional systemic rheumatic condition-specific training who will work with the CRS.

After 6 months, patients who do not respond to Arm 1 will move to Arm 2. Patients who do not respond to Arm 2, will move to Arm 3. Patients who do not respond to Arm 3 will remain in Arm 3. Patients who respond to any arm will graduate the program at 6 months. The patients who do not respond be in their new arm for 6 months. At 12 months, all patients remaining in the study will graduate.

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

Interventions

OTHER

Resource sheets

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.

OTHER

Community Resource Specialist

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).

OTHER

Nurse Navigator

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.

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Candace H Feldman, MD, MPH, ScD · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2025-10-14

Completion

2026-12-01

Countries

• United States

Study Locations