Supportive Care for Arthritis
(RAISE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different support systems can help people with inflammatory arthritis manage their care more effectively. It tests three approaches: providing a list of helpful resources, support from a Community Resource Specialist familiar with local services, and guidance from a Nurse Navigator trained in rheumatic conditions. The goal is to determine which method reduces missed appointments and improves cost-effectiveness. The trial seeks participants with arthritis who have previously missed appointments and have needs related to social factors like housing or access to food. Participants must receive care at specific hospitals in the Boston area. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support systems for arthritis care.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing support and resources rather than changing medical treatments.
Is there any evidence suggesting that this trial's interventions are likely to be safe?
Research has shown that community resource specialists (CRS) and nurse navigators in healthcare are generally well-received. These roles assist patients by linking them to necessary resources and organizing their care. Studies have found that when nurses teach patients, it can enhance patient safety skills, especially for those with conditions like arthritis. This suggests that trained healthcare workers, such as nurse navigators, typically do not cause negative effects.
Community resource specialists might lack formal medical training, but they possess extensive knowledge of local services and help individuals manage their healthcare needs. Although less information exists about the safety of CRS specifically, their role involves providing guidance and resources, which does not entail physical risks.
Both roles aim to improve healthcare without introducing new medical treatments, so they are generally considered safe. The primary goal is to offer support and improve access to care, not to provide treatments with physical side effects.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to explore new ways to support individuals with arthritis beyond the usual medications and physical therapies. Arm 2 introduces a community resource specialist, someone with deep-rooted community knowledge but no formal medical training, offering a fresh perspective on patient support. Arm 3 features a bilingual nurse patient navigator who is not only skilled in nursing but also has specialized rheumatology training, providing more personalized care, especially for Spanish-speaking patients. These approaches could enhance patient understanding and management of arthritis in ways that traditional resource sheets and standard care might not achieve.
What evidence suggests that this trial's treatments could be effective for arthritis?
This trial will compare different supportive care approaches for arthritis. Participants in Arm 2 will receive assistance from community resource specialists, who have shown in past studies to help arthritis patients improve work attendance and manage their condition. Arm 3 participants will receive guidance from a bilingual nurse patient navigator, which studies indicate can enhance quality of life and reduce missed or canceled appointments. Both methods aim to support patients by connecting them with important resources and coordinated care. Arm 1 will serve as the control arm, receiving standard resource sheets.678910
Who Is on the Research Team?
Candace H Feldman, MD, ScD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Intervention
Participants are assigned to one of three arms to address SDoH-related needs: Arm 1 receives standard care resource sheets, Arm 2 receives assistance from a community resource specialist, and Arm 3 receives assistance from a nurse patient navigator.
Adaptive Intervention
Participants who do not respond to their initial arm are reassigned to a more intensive intervention for another 6 months.
Follow-up
Participants are monitored for outcomes such as appointment adherence and SDoH-related needs resolution.
What Are the Treatments Tested in This Trial?
Interventions
- Community Resource Specialist
- Nurse Navigator
- Resource sheets
- Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Bristol-Myers Squibb Foundation
Collaborator
Bristol-Myers Squibb
Industry Sponsor
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