Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
792 participants
INTERVENTIONAL
2022-09-19
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
NCT03773471
CONfident Treatment Decisions in Living With Rheumatoid Arthritis
NCT03317756
App-based Education and GOal-setting in Rheumatoid Arthritis
NCT05888181
Patient Education in Rheumatoid Arthritis and Osteoarthritis
NCT00000414
Arthritis Self-Management Education Program
NCT00467064
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Significance/Impact: Veterans with RA are disproportionately male, have more comorbidities, and higher mortality rates in comparison to the general population. SDM is the first principal of the RA treat to target guidelines. However, significant gaps in knowledge of effective interventions to support SDM exist - particularly in VA. This proposal is responsive to three VA HSR\&D priority domains: 1) health care value, 2) quality of health care, and 3) health equity.
Innovation: Treatment studies in RA have focused primarily on white women, while men, who represent the VA RA population, have poorer outcomes. Targeting this subgroup to evaluate the impact of an SDM intervention on disease outcomes and adherence is novel. Use of a novel approach combining clinician training and a decision aid to recognize the unique needs of Veterans with RA is innovative.
Specific Aims: Aim 1: Evaluate the effectiveness of a multi-component SDM intervention in a stepped-wedge, cluster-randomized controlled trial on improvement in disease activity, RA knowledge, and adherence. Hypothesis 1: During SDM intervention phases, Veterans will have lower disease activity compared to during control periods and will be more likely to experience clinically important differences in a standard disease activity index. Hypothesis 2: Veterans will have greater RA knowledge and better adherence after exposure to this intervention. Exploratory Hypothesis: The SDM intervention will have a greater effect in the likelihood of lowering disease activity among racial/ethnic minorities and Veterans with limited health literacy. Aim 2: Evaluate effectiveness of a multi-component intervention to facilitate SDM. Hypothesis: An SDM intervention for Veterans with RA will result in higher uptake of SDM in enrolled clinics during the intervention phase, relative to control phase. Aim 3: Conduct a qualitative evaluation of the SDM intervention and local implementation to inform future dissemination.
Methodology: A stepped-wedge, cluster-randomized controlled trial design will be used to evaluate effectiveness of a novel SDM intervention across three sites. Participants: Veterans with RA and rheumatology clinicians; Intervention: multicomponent SDM intervention ; Control: participants at each site during the pre-intervention period; Outcomes: RA disease activity; patient-reported measures of adherence, knowledge, SDM, and an objective measure of SDM. Time: pre-intervention, intervention, and post-intervention phases for each step, measures collected over 42 months.
Implementation/Next Steps: The proposed effectiveness study has the potential to speed the translation of SDM research within VA and nationally to improve quality of care for all persons with RA.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Usual care
No interventions assigned to this group
Intervention
Intervention phase
Clinician communication training
The clinician training is a generic, skills- and attitude-based approach for clinicians to acknowledge their decision making conversations with patients that 1) there is more than one option, and 2) patient's views matter in deciding what to do next. This tools-free approach can be used on the spot when needed and is termed fostering choice awareness (FCA). The one-hour training consists of 4 parts: 1) a knowledge session on evidence and guidelines on effective conversations and SDM, 2) video-review of behaviors which foster or hinder choice awareness, 3) clinical simulations in which clinicians practice fostering choice awareness behaviors, and 4) a reminder card for use in future clinic visits. Video clips will be of patient-clinician conversations around treatment decision making to prompt and probe clinicians' experiences, improve understanding, and improve practice.
Patient activation
The patient activation component consists of three questions patients can ask their clinician to help them become more involved: "1. What are my options?; 2. What are the possible benefits and harms of those options?; 3. How likely are each of those benefits and harms to happen to me?" These questions have been used in studies to promote improved communication in a number of conditions including cardiovascular disease, cancer, and women's health.
RA Medication summary guide and RA Choice
RA Choice presents information on FDA-approved RA treatments in a set of cards, which can be used alone or in combination based on a patient's preference, values, and the clinician's experience. The RA medication summary guide describes options for medication, physical therapy, occupational therapy, and ways to stay healthy with diet and exercise. Tool development followed key principles of creating low literacy materials that featured icons, short phrases written in plain language, and included topics of interest to RA patients faced with a medication decision. For the proposed study, we will include a paper-based version of the tool, or a web-based version available for telephone or VA Video Connect (VVC) visits. The tools will be updated to include new FDA-approved therapies (e.g., JAK inhibitors).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinician communication training
The clinician training is a generic, skills- and attitude-based approach for clinicians to acknowledge their decision making conversations with patients that 1) there is more than one option, and 2) patient's views matter in deciding what to do next. This tools-free approach can be used on the spot when needed and is termed fostering choice awareness (FCA). The one-hour training consists of 4 parts: 1) a knowledge session on evidence and guidelines on effective conversations and SDM, 2) video-review of behaviors which foster or hinder choice awareness, 3) clinical simulations in which clinicians practice fostering choice awareness behaviors, and 4) a reminder card for use in future clinic visits. Video clips will be of patient-clinician conversations around treatment decision making to prompt and probe clinicians' experiences, improve understanding, and improve practice.
Patient activation
The patient activation component consists of three questions patients can ask their clinician to help them become more involved: "1. What are my options?; 2. What are the possible benefits and harms of those options?; 3. How likely are each of those benefits and harms to happen to me?" These questions have been used in studies to promote improved communication in a number of conditions including cardiovascular disease, cancer, and women's health.
RA Medication summary guide and RA Choice
RA Choice presents information on FDA-approved RA treatments in a set of cards, which can be used alone or in combination based on a patient's preference, values, and the clinician's experience. The RA medication summary guide describes options for medication, physical therapy, occupational therapy, and ways to stay healthy with diet and exercise. Tool development followed key principles of creating low literacy materials that featured icons, short phrases written in plain language, and included topics of interest to RA patients faced with a medication decision. For the proposed study, we will include a paper-based version of the tool, or a web-based version available for telephone or VA Video Connect (VVC) visits. The tools will be updated to include new FDA-approved therapies (e.g., JAK inhibitors).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
-Rheumatology attendings, fellows or advanced practice partners (nurse practitioners or physicians assistants) at the respective clinics
* 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
* Inability to speak
-none
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Barton, MD
Role: PRINCIPAL_INVESTIGATOR
VA Portland Health Care System, Portland, OR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
Wilmington VA Medical Center, Wilmington, DE
Wilmington, Delaware, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Barton JL, Markwardt S, Niederhausen M, Schue A, Dougherty J, Katz P, Saha S, Yelin EH. Are We on the Same Page? A Cross-Sectional Study of Patient-Clinician Goal Concordance in Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2023 Mar;75(3):625-633. doi: 10.1002/acr.24794. Epub 2022 Nov 16.
Morrison T, Foster E, Dougherty J, Barton J. Shared decision making in rheumatology: A scoping review. Semin Arthritis Rheum. 2022 Oct;56:152041. doi: 10.1016/j.semarthrit.2022.152041. Epub 2022 Jun 3.
Hulen E, Larsen C, Matsumoto R, Katz P, Barton JL. "You can't touch, you can't bond": Exploring COVID-19 pandemic impacts on rheumatoid arthritis patient goals and communication with clinicians. Musculoskeletal Care. 2023 Mar;21(1):244-248. doi: 10.1002/msc.1689. Epub 2022 Sep 8. No abstract available.
Singh N, Grivas P, Makris UE, Suarez-Almazor ME, O'Hare AM, Barton JL. Use of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: Supporting Shared Decision-Making Between Patients With Cancer and Clinicians. ACR Open Rheumatol. 2023 Jun;5(6):305-307. doi: 10.1002/acr2.11552. Epub 2023 May 11. No abstract available.
Baker R, Mantilla B, Graf J, Katz PP, Goglin S, Barton JL, Liew JW, Wysham KD. Racial and Ethnic Differences in a Biochemical Marker of Rheumatoid Arthritis Disease Activity. ACR Open Rheumatol. 2023 Mar;5(3):142-148. doi: 10.1002/acr2.11524. Epub 2023 Feb 8.
McGoldrick J, Molina-Ochoa D, Schwab P, Edwards ST, Barton JL. An Evaluation of Burnout Among US Rheumatology Fellows: A National Survey. J Rheumatol. 2023 Sep;50(9):1185-1190. doi: 10.3899/jrheum.221114. Epub 2023 Mar 15.
England BR, Smith BJ, Baker NA, Barton JL, Oatis CA, Guyatt G, Anandarajah A, Carandang K, Chan KK, Constien D, Davidson E, Dodge CV, Bemis-Dougherty A, Everett S, Fisher N, Fraenkel L, Goodman SM, Lewis J, Menzies V, Moreland LW, Navarro-Millan I, Patterson S, Phillips LR, Shah N, Singh N, White D, AlHeresh R, Barbour KE, Bye T, Guglielmo D, Haberman R, Johnson T, Kleiner A, Lane CY, Li LC, Master H, Pinto D, Poole JL, Steinbarger K, Sztubinski D, Thoma L, Tsaltskan V, Turgunbaev M, Wells C, Turner AS, Treadwell JR. 2022 American College of Rheumatology Guideline for Exercise, Rehabilitation, Diet, and Additional Integrative Interventions for Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1603-1615. doi: 10.1002/acr.25117. Epub 2023 May 25.
Barton JL. Unequal Treatment: Physical Therapy Utilization in Rheumatoid Arthritis. J Rheumatol. 2023 Nov;50(11):1359-1361. doi: 10.3899/jrheum.2023-0814. Epub 2023 Sep 15. No abstract available.
Nasrallah C, Schmajuk G, Hamblin A, Wilson C, Kersey E, Young C, Katz P, Bajaj P, Downey C, Bartels C, Zell J, Danila MI, Ferguson S, Barton JL, DeQuattro K, Yazdany J. Leveraging the Consolidated Framework for Implementation Research to Develop the American College of Rheumatology's Toolkit for Implementation of Rheumatoid Arthritis Outcome Measures in Clinical Practice: A Qualitative Study. Arthritis Care Res (Hoboken). 2024 Dec;76(12):1647-1656. doi: 10.1002/acr.25410. Epub 2024 Sep 5.
Decary S, de Wit M, Naye F, Barton JL, Fraenkel L, Li LC, Brooks P, Stacey D, Maxwell LJ, Campbell W, Hofstetter C, Voshaar M, Meara A, Christensen R, Boonen A, Suarez-Almazor ME, Meade T, March L, Jull JE, Alten R, Morgan EM, Stewart Hazlewood G, Barber CEH, Guillemin F, El-Miedany Y, Mittoo S, Robertson TW, Bartlett SJ, Singh JA, Mannion M, Nasef SI, Boel A, Adebajo A, Arnaud L, Gill TK, Moholt E, Burt J, Jayatilleke A, Hmamouchi I, Berthelsen DB, Blanco FJ, Mather K, Maharaj A, Sharma S, Caso F, Beaton D, Shea B, Fong C, Fernandez AP, Mackie S, Nikiphorou E, Jones A, Greer-Smith R, Sloan VS, Akpabio A, Strand V, Lee RR, Umaefulam V, Monti S, Abaza N, Schultz G, Stones S, Gossec L, Nielsen SM, Cavallo S, Srinivasalu H, Constien D, Evans V, Tugwell P, Toupin-April K. Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials. Semin Arthritis Rheum. 2024 Apr;65:152381. doi: 10.1016/j.semarthrit.2024.152381. Epub 2024 Jan 15.
Maxwell LJ, Wright GC, Schultz G, Grosskleg S, Barton JL, Campbell W, Guillemin F, Hofstetter C, Shea BJ, Simon LS, Adebajo A, Barnabe C, Goel N, Hurley P, Nikiphorou E, Petkovic J, Tugwell P. Embracing unity at OMERACT: Valuing equity, promoting diversity, fostering inclusivity. Semin Arthritis Rheum. 2024 Jun;66:152422. doi: 10.1016/j.semarthrit.2024.152422. Epub 2024 Feb 29.
Naye F, Toupin-April K, de Wit M, LeBlanc A, Dubois O, Boonen A, Barton JL, Fraenkel L, Li LC, Stacey D, March L, Barber CEH, Hazlewood GS, Guillemin F, Bartlett SJ, Berthelsen DB, Mather K, Arnaud L, Akpabio A, Adebajo A, Schultz G, Sloan VS, Gill TK, Sharma S, Scholte-Voshaar M, Caso F, Nikiphorou E, Nasef SI, Campbell W, Meara A, Christensen R, Suarez-Almazor ME, Jull JE, Alten R, Morgan EM, El-Miedany Y, Singh JA, Burt J, Jayatilleke A, Hmamouchi I, Blanco FJ, Fernandez AP, Mackie S, Jones A, Strand V, Monti S, Stones SR, Lee RR, Nielsen SM, Evans V, Srinivasalu H, Gerard T, Demers JL, Bouchard R, Stefan T, Dugas M, Bergeron F, Beaton D, Maxwell LJ, Tugwell P, Decary S. OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments. Semin Arthritis Rheum. 2024 Apr;65:152344. doi: 10.1016/j.semarthrit.2023.152344. Epub 2023 Dec 16.
England BR, Smith BJ, Baker NA, Barton JL, Oatis CA, Turner AS. Reply. Arthritis Care Res (Hoboken). 2024 Mar;76(3):438-439. doi: 10.1002/acr.25255. Epub 2023 Dec 17. No abstract available.
Schue A, Matsumoto R, Barton J. Goal Concordance in Rheumatoid Arthritis Patients with Depression - What Do Patients Prioritize? [Abstract]. Arthritis & rheumatology (Hoboken, N.J.). 2023 Nov 14; 75(Suppl 9):2032.
Barton JL, Niederhausen M, Tuepker A, Schmajuk G, Baker J, Lovejoy TI, Morasco BJ, Kunneman M, Scholl I. Implementation of shared decision making in rheumatoid arthritis: study protocol for RAiSeD (Rheumatoid Arthritis Shared Decision Making) stepped wedge, cluster-randomized trial. Trials. 2025 Sep 29;26(1):381. doi: 10.1186/s13063-025-09015-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIR 20-162
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.