Improving decision making for veterans with rheumatoid arthritis
Implementation of Shared Decision Making in Rheumatoid Arthritis: A Stepped Wedge, Cluster-randomized Trial
This study is testing a new approach to help veterans with rheumatoid arthritis make better treatment decisions together with their doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 792 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | methotrexate |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Trial ID | NCT05530694 on ClinicalTrials.gov |
What this trial studies
This project evaluates a multi-component intervention aimed at enhancing shared decision making (SDM) in the treatment of rheumatoid arthritis (RA) among veterans. The intervention includes clinician communication training, patient activation strategies, and the use of decision aids to improve patient knowledge and adherence to RA medications. By fostering collaboration between patients and clinicians, the study seeks to address health disparities and improve disease outcomes in a population that has been historically underserved. The research will provide insights into effective strategies for implementing SDM in VA rheumatology settings.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 and older who have been diagnosed with rheumatoid arthritis and have moderate to high disease activity.
Not a fit: Patients with cognitive impairments or those unable to participate in shared decision making due to other limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved disease management and quality of life for veterans with rheumatoid arthritis.
How similar studies have performed: While shared decision making has been proposed as a beneficial approach, there is limited evidence on its effective implementation in VA settings, making this study a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria for patient participants (Aims 1 \& 2): * Meet administrative data definition of rheumatoid arthritis (see recruitment section) * Receive rheumatology outpatient care at participating clinics and seen at least once in prior 12 months * Age 18 years or older * English speaking * Moderate to high RA disease activity within 18 months prior to enrollment Inclusion criteria for professional participants (Aims 1-3): -Rheumatology attendings, fellows or advanced practice partners (nurse practitioners or physicians assistants) at the respective clinics Inclusion criteria for non-clinician participants (Aim 3): * Have held a leadership position within their respective institution for minimum of 12 months prior to enrollment * Have worked in the rheumatology clinic setting at their respective institution for minimum of 12 months prior Exclusion Criteria: Exclusion criteria for patient participants (Aims 1 \& 2): * Cognitive impairment * Inability to speak Exclusion criteria for professional participants (Aims 1-3): -none Exclusion criteria for non-clinician participants (Aim 3): * Have held a leadership position within their respective institution for \<12 months * Have worked in a clinic setting other than rheumatology * Have worked in a clinic setting \<12 months
Where this trial is running
San Francisco, California and 3 other locations
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (Recruiting)
- Wilmington VA Medical Center, Wilmington, DE — Wilmington, Delaware, United States (Recruiting)
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (Recruiting)
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Barton, MD — VA Portland Health Care System, Portland, OR
- Study coordinator: Jennifer Barton, MD
- Email: Jennifer.Barton1@va.gov
- Phone: (503) 220-8262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.