Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity
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
More conditions available...
🗓️ Study Start (Actual)
1 March 2023
🗓️ Primary Completion (Estimated)
30 December 2026
✅ Study Completion (Estimated)
1 April 2027
👥 Enrollment (Estimated)
258
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Boston, Massachusetts, United States
Description
Inclusion Criteria:
- * English or Spanish-speaking
- * 18+ years of age
- * diagnosis of a systemic rheumatic condition with arthritis
- * 1+ prior no-show(s) or same day cancellation(s) to an ambulatory care provider in the past year
- * 1+ 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
Exclusion Criteria:
- * 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
Ages Eligible for Study:
18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
19 January 2023
- First Submitted that Met QC Criteria
27 January 2023
- First Posted
8 February 2023
Study Record Updates
- Last Update Submitted that Met QC Criteria
7 March 2024
- Last Update Posted
12 March 2024
- Last Verified
March 2024