Supportive Care for Arthritis

(RAISE Trial)

Overseen By Rebecca Summit

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Incarceration, Integrated care program, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

101 Participants Needed

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.

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.

What data supports the effectiveness of the treatment Community Resource Specialist, Nurse Navigator, Resource sheets, Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity for arthritis?

Research shows that involving nurses and community health professionals in arthritis care can improve management and patient education, which are key to better outcomes. Additionally, self-management programs and patient education strategies tailored to individual needs have been recognized as important for quality care in arthritis management. ^{1 2 3 4 5}

Is the supportive care treatment for arthritis safe for humans?

The research articles discuss adverse events (unintended harm from medical care) in community care settings, highlighting the importance of improving patient safety and reporting systems. While they don't specifically address the safety of the supportive care treatment for arthritis, they emphasize the need for careful monitoring and reporting of any adverse events in healthcare settings to ensure patient safety. ^{6 7 8 9 10}

How is the Supportive Care for Arthritis treatment different from other treatments for arthritis?

This treatment is unique because it involves a Community Resource Specialist and Nurse Navigator, focusing on providing support and resources to help patients manage their arthritis at home, rather than relying solely on medication or hospital visits. It emphasizes personalized care and education, empowering patients to self-manage their condition with the help of community-based healthcare professionals. ^{1 11 12 13 14}

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

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 Brigham and Women's Hospital or Faulkner Hospital affiliated clinic

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 months

Minimum of 2 interactions per month

Adaptive Intervention

Participants who do not respond to their initial arm are reassigned to a more intensive intervention for another 6 months.

6 months

Follow-up

Participants are monitored for outcomes such as appointment adherence and SDoH-related needs resolution.

12 months

Treatment Details

Interventions

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

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

Findings from Research

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

A consensus workshop with 31 healthcare professionals identified and ranked common adverse events in community care, highlighting the need for better understanding of how these events affect care quality.

The workshop emphasized the importance of further research to establish standardized definitions of adverse events and to prioritize research questions that can improve patient safety in community care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. Masotti, P., Green, M., Shortt, S., et al.[2022]

About 63% of long-term care facilities in the Czech Republic have some form of adverse event reporting process, but many of these systems are underdeveloped and rely mainly on paper records.

Interviews revealed that while staff recognize the importance of reporting adverse events, there is a significant gap in knowledge and skills needed to create effective reporting systems, indicating a need for better training and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in Czech long-term care facilities. Hěib, Z., Vychytil, P., Marx, D.[2016]

References

1. Portugal pubmed.ncbi.nlm.nih.gov

Applicability of the EULAR recommendations on the role of the nurse in the management of chronic inflammatory arthritis in Portugal. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Two-year follow-up of a randomized controlled trial of a clinical nurse specialist intervention, inpatient, and day patient team care in rheumatoid arthritis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Better arthritis care: Patients' expectations and priorities, the competencies that community-based health professionals need to improve their care of people with arthritis? [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

What Is Relatives' Role in Arthritis Management? A Qualitative Study of the Perceptions of Patient-Relative Dyads. [2022]

5. England pubmed.ncbi.nlm.nih.gov

PROMs: a novel approach to arthritis self-management. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Statewide identification of adverse events using retrospective nurse review: methods and outcomes. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Reporting of adverse drug reactions by nurses. [2016]

9. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in Czech long-term care facilities. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Patients with inflammatory arthritis: an opportunity for community nurses. [2011]

12. United States pubmed.ncbi.nlm.nih.gov

Living With Rheumatoid Arthritis in Spain: A Qualitative Study of Patient Experience and the Role of Health Professionals. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Understanding the needs of older people with rheumatoid arthritis: the role of the community nurse. [2016]

14. England pubmed.ncbi.nlm.nih.gov

EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis. [2022]