Rheumatoid Arthritis Shared Decision Making

NCT05530694 | Completed DMC

• 1 other identifier: IIR 20-162
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 4

Brief Summary

Shared decision making is the first overarching principle for the treat to target guidelines for rheumatoid arthritis (RA) and has been proposed as a potential mechanism to reduce health disparities, however there is little evidence to inform effective ways to implement this practice in the care of Veterans with RA. The purpose of this project is to evaluate the effectiveness of a multi-component shared decision making intervention on RA disease activity, adherence to RA medications and patient knowledge of RA. The proposed research will contribute to fundamental knowledge about how to effectively foster shared decision making across varied VA rheumatology clinical settings to improve patient disease outcomes and experience; and support clinicians to engage patients in meaningful ways with the ultimate goal to improve health, reduce disability, and eliminate disparities.

Conditions

Rheumatoid Arthritis

Keywords

shared decision making; rheumatoid arthritis; rheumatology

Outcome Measures

Primary Outcomes (1)

• Disease activity

  RA disease activity will be measured using composite score: the Clinical Disease Activity Index (range 0-76) or CDAI. This is a composite score of clinician assessed swollen and tender joints counts, clinician global assessment and patient global assessment of disease activity. Higher score is indicative of higher disease activity.

  through study completion (up to 4 years), on average 3 times per year

Secondary Outcomes (5)

• Change in rheumatoid arthritis knowledge

  measured at baseline, 6 months and 12 months on a subset

• Change in adherence

  measured at baseline, 6 months and 12 months on a subset

• CollaboRATE questionnaire

  through study completion (up to 4 years), on average 3 times per year

• Change in OPTION-5 (objective measure of shared decision making)

  through study completion (up to 4 years), on average 1 time per year

• SURE questionnaire

  through study completion (up to 4 years), on average 3 times per year

Study Arms (2)

Control

NO INTERVENTION

Usual care

Intervention

EXPERIMENTAL

Intervention phase

Behavioral: Clinician communication training; Behavioral: Patient activation; Behavioral: RA Medication summary guide and RA Choice

Interventions

Clinician communication training BEHAVIORAL

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.

Also known as: fostering choice awareness

Intervention

Patient activation BEHAVIORAL

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.

Also known as: AskShareKnow

Intervention

RA Medication summary guide and RA Choice BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Cognitive impairment
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Wilmington VA Medical Center, Wilmington, DE

Wilmington, Delaware, 19805-4917, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (15)

• 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.

  PMID: 34569172 BACKGROUND

• 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.

  PMID: 35738040 BACKGROUND

• 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.

  PMID: 36073563 BACKGROUND

• 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.

  PMID: 37166652 BACKGROUND

• 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.

  PMID: 36754575 BACKGROUND

• 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.

  PMID: 36921966 BACKGROUND

• 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.

  PMID: 37227116 BACKGROUND

• 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.

  PMID: 37714545 BACKGROUND

• 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.

  PMID: 39099213 BACKGROUND

• 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.

  PMID: 38306813 BACKGROUND

• 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.

  PMID: 38461757 BACKGROUND

• 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.

  PMID: 38232625 BACKGROUND

• 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.

  PMID: 37818722 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 41024266 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jennifer Barton, MD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: September 7, 2022
• Study Start: September 19, 2022
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)