Supportive Care for Arthritis

(RAISE Trial)

Overseen by Candace H Feldman, MD, ScD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Candace H Feldman, MD, ScD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults over 18 with arthritis-related rheumatic conditions who missed at least one clinic visit in the past year and have social needs, except unemployment or education. They must be getting care at specific hospitals, speak English or Spanish, and not be enrolled in certain other care programs.

Inclusion Criteria

I am 18 years old or older.

1+ prior no-show(s) or same day cancellation(s) to an ambulatory care provider in the past year

I speak English or Spanish.

Exclusion Criteria

Incarcerated individuals

Patients already actively enrolled in an integrated care management program through their primary care provider

I have chosen not to be contacted for research in my electronic health records.

Treatment Details

Interventions

• Community Resource Specialist (Behavioural Intervention)
• Nurse Navigator (Behavioural Intervention)
• Resource sheets (Behavioural Intervention)
• Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity (Behavioural Intervention)

Trial Overview The study tests three support strategies for patients with systemic rheumatic conditions: a tailored resource list (Arm 1), help from a community specialist (Arm 2), and assistance from a nurse navigator trained in these conditions working with the community specialist (Arm 3).

Participant Groups

Group I: Arm 3 Experimental Treatment 1 Intervention

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

Group II: Arm 2 Experimental Treatment 1 Intervention

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

Group III: Arm 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Bristol-Myers Squibb Foundation

Collaborator

Trials

6

Recruited

1,300+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania