Clinical trial NCT05530694: Rheumatoid Arthritis Shared Decision Making
Official title: Implementation of Shared Decision Making in Rheumatoid Arthritis: A Stepped Wedge, Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: shared decision making
rheumatoid arthritis
rheumatology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-09-07
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Background: Rheumatoid arthritis (RA) impacts quality of life causing disability in up to 1% of the population and 2% of those 60 and older. Men with RA have twice the risk of death as the general population. Treatment decisions after failure with first-line methotrexate are complex, involve trade-offs in terms of harm, and require individualized decisions. In shared decision making (SDM), patients and clinicians work together to identify how to best address the patient's situation. SDM has been proposed as a way to reduce disparities, but uptake is suboptimal and no effective tools to foster SDM in a systematic way across VA exist.

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.

Eligibility 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

Primary outcomes:
measure: Disease activity
timeFrame: through study completion (up to 4 years), on average 3 times per year
Secondary outcomes:
measure: Change in rheumatoid arthritis knowledge
timeFrame: measured at baseline, 6 months and 12 months on a subset
measure: Change in adherence
timeFrame: measured at baseline, 6 months and 12 months on a subset
measure: CollaboRATE questionnaire
timeFrame: through study completion (up to 4 years), on average 3 times per year
measure: Change in OPTION-5 (objective measure of shared decision making)
timeFrame: through study completion (up to 4 years), on average 1 time per year
measure: SURE questionnaire
timeFrame: through study completion (up to 4 years), on average 3 times per year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Wilmington
country: United States
facility: Wilmington VA Medical Center, Wilmington, DE
state: Delaware
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Jennifer Barton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.