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NCT05715463
Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity
Conditions: Inflammatory Arthritis
Sex: All
Ages: 18 Years – 100 Years
Phase: NA
Enrollment: 258
Sponsor: Brigham and Women's Hospital
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 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: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 inflammatory arthritis.To examine the cost-effectiveness of each of the different study interventions for individuals with inflammatory 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 inflammatory arthritis-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.
Eligibility Criteria
Inclusion Criteria:English or Spanish-speaking18+ years of agediagnosis of inflammatory arthritis1+ prior no-shows to an ambulatory care provider in the past year1+ social determinants of health needs on Mass General Brigham questionnaire (excluding unemployment and education)Receiving rheumatology care at a Brigham and Women's Hospital or Faulkner Hospital affiliated clinicExclusion Criteria:Incarcerated individualsIndicated through our EHR that they do not want to be contacted for researchPatients already actively enrolled in an integrated care management program through their primary care providerMedical complexity that requires urgent nursing involvement and thus not medically appropriate for randomization
Source: ClinicalTrials.gov (NCT05715463). StuddyBuddy aggregates publicly available trial information.