Shared Decision Making Intervention for Rheumatoid Arthritis

(RAiSeD Trial)

Recruiting at 3 trial locations

Overseen By Alexandra Bennett

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Inability to speak

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

Compensation: Varies

Number of Visits: Unknown

792 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It focuses on shared decision making and adherence to RA medications, so it's best to discuss your specific situation with the trial coordinators.

What data supports the effectiveness of the Shared Decision Making Intervention for Rheumatoid Arthritis treatment?

Research shows that using shared decision-making tools, like decision aids, can improve patients' understanding of their rheumatoid arthritis medications and help them communicate better with their doctors about treatment options. This approach can enhance patient engagement and adherence to treatment plans. ^{1 2 3 4 5}

Is the Shared Decision Making Intervention for Rheumatoid Arthritis safe for humans?

The research articles focus on developing tools to help patients and doctors make decisions together about rheumatoid arthritis treatments, but they do not provide specific safety data for the Shared Decision Making Intervention itself. ^{1 2 3 4 6}

How is the shared decision-making treatment for rheumatoid arthritis different from other treatments?

This treatment is unique because it focuses on shared decision-making, using tools like decision aids to help patients understand their medication options and communicate effectively with their doctors, especially for those with low literacy or language barriers. ^{1 2 3 5 7}

Research Team

Jennifer Barton, MD

Principal Investigator

VA Portland Health Care System, Portland, OR

Eligibility Criteria

This trial is for adults with moderate to high rheumatoid arthritis activity who have been treated at participating clinics in the past year. It includes patients, clinicians, and non-clinician leaders involved in RA care. Participants must speak English and not have cognitive impairments that would prevent participation.

Inclusion Criteria

Non-clinician participants must have held a leadership position within their respective institution for a minimum of 12 months prior to enrollment

Professional participants must be Rheumatology attendings, fellows, or advanced practice partners (nurse practitioners or physicians assistants) at the respective clinics

Non-clinician participants must have worked in the rheumatology clinic setting at their respective institution for a minimum of 12 months prior

Exclusion Criteria

I am unable to speak.

Patient participants with cognitive impairment

Non-clinician participants who have worked in a clinic setting for less than 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants receive usual care before the intervention phase begins

Varies by site

Intervention

Implementation of a multi-component shared decision making intervention

42 months

Follow-up

Participants are monitored for disease activity, adherence, and shared decision making uptake

Up to 4 years

Treatment Details

Interventions

• Clinician communication training
• Patient activation
• RA Medication summary guide and RA Choice

Trial Overview The study tests a shared decision-making intervention aimed at improving RA disease outcomes. This involves an RA medication guide (RA Choice), training clinicians on communication, and activating patients to engage in their treatment choices.

Participant Groups

Group I: Intervention Experimental Treatment 3 Interventions

Intervention phase

Group II: Control Active Control 1 Intervention

Usual care

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The RA Choice decision aid was developed collaboratively to help patients with rheumatoid arthritis make informed medication choices, using low literacy principles and available in three languages.

Field-testing showed that the tool effectively facilitated communication between clinicians and patients, making it easier for those with limited health literacy to understand treatment options and engage in shared decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The design of a low literacy decision aid about rheumatoid arthritis medications developed in three languages for use during the clinical encounter. Barton, JL., Koenig, CJ., Evans-Young, G., et al.[2018]

A pilot study involving 166 rheumatoid arthritis patients showed that using a low-literacy medication guide and decision aid significantly improved patients' knowledge about their medications, with 78% of those using the decision aid demonstrating adequate knowledge compared to only 53% in the control group.

The decision aid also reduced decisional conflict among patients who changed their medication, indicating that these tools can enhance patient engagement and lead to more informed medication choices that align with patients' values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Low-Literacy Decision Aid to Enhance Knowledge and Reduce Decisional Conflict Among a Diverse Population of Adults With Rheumatoid Arthritis: Results of a Pilot Study. Barton, JL., Trupin, L., Schillinger, D., et al.[2022]

A study involving 108 participants, including 78 patients and their relatives, and 39 rheumatologists, found that both patients and doctors prioritize safety and shared decision-making when considering preventive treatments for rheumatoid arthritis.

Despite similarities in preferences, patients and their relatives showed a stronger focus on the method of treatment administration, while rheumatologists emphasized the certainty of evidence, highlighting the need for tailored communication in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for treatments to prevent rheumatoid arthritis in Canada and the influence of shared decision-making. Harrison, M., Bansback, N., Aguiar, M., et al.[2021]

A survey involving 944 rheumatoid arthritis patients identified that the most important treatment attributes are the route of administration and dosing frequency (38%), followed closely by serious side effects (33%).

The results indicate a strong potential for developing a shared decision-making tool that aligns with patient preferences, showing good stability and reliability in treatment attribute importance among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Interactive Tool to Support Shared Decision-Making in Rheumatoid Arthritis: Treatment Attribute Preference. Curtis, JR., Ford, K., Fiore, S., et al.[2023]

Shared decision-making (SDM) is increasingly recognized as essential for improving care in rheumatoid arthritis, but its implementation in clinical practice remains suboptimal despite the availability of decision aids that enhance patient knowledge and communication with clinicians.

Recent studies suggest that innovative SDM strategies, like setting shared goals and understanding patient preferences, could improve the effectiveness of treatment approaches, but large-scale implementation of these strategies is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New galaxies in the universe of shared decision-making and rheumatoid arthritis. Barton, JL., Décary, S.[2022]

The online patient decision aid significantly reduced decisional conflict among patients considering methotrexate for rheumatoid arthritis, with scores improving from an average of 49.50 to 21.83 after the intervention (P < 0.001).

Participants' knowledge about methotrexate also increased significantly, with scores rising from 30.62 to 41.67 (P < 0.001), indicating that the decision aid effectively enhanced understanding of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof-of-concept study of a Web-based methotrexate decision aid for patients with rheumatoid arthritis. Li, LC., Adam, PM., Backman, CL., et al.[2022]

A web-based survey involving 107 physicians and 217 patients with rheumatoid arthritis revealed that physicians reported higher shared decision-making (SDM) scores (74.5 for csDMARDs and 77.2 for biological drugs/JAK inhibitors) compared to patients' scores (62.3 for csDMARDs and 72.6 for biological drugs/JAK inhibitors).

The findings indicate a gap in perceived SDM levels between physicians and patients, suggesting that while physicians feel they engage in SDM, patients may not feel as involved, particularly with conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of shared decision making for rheumatoid arthritis treatment in Japan: a web-based survey on physicians and patients. Tsuboi, H., Kaneko, Y., Ikeda, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The design of a low literacy decision aid about rheumatoid arthritis medications developed in three languages for use during the clinical encounter. [2018]

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

Use of Low-Literacy Decision Aid to Enhance Knowledge and Reduce Decisional Conflict Among a Diverse Population of Adults With Rheumatoid Arthritis: Results of a Pilot Study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Preferences for treatments to prevent rheumatoid arthritis in Canada and the influence of shared decision-making. [2021]

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

Development of an Interactive Tool to Support Shared Decision-Making in Rheumatoid Arthritis: Treatment Attribute Preference. [2023]

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

New galaxies in the universe of shared decision-making and rheumatoid arthritis. [2022]

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

Proof-of-concept study of a Web-based methotrexate decision aid for patients with rheumatoid arthritis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Current status of shared decision making for rheumatoid arthritis treatment in Japan: a web-based survey on physicians and patients. [2022]