Shared Decision Making Intervention for Rheumatoid Arthritis

(RAiSeD Trial)

Recruiting at 3 trial locations

Overseen By Alexandra P 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how doctors and patients collaboratively decide on rheumatoid arthritis (RA) treatments, with a focus on veterans. It examines whether improved communication and clear information about RA medications can more effectively manage the disease, enhance medication use, and increase patient understanding. Participants will either experience this new approach, which includes clinician communication training and patient activation strategies, or continue with their usual care. Individuals with moderate to high RA symptoms who have received care at participating clinics in the past year may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to advancements in RA care and patient outcomes.

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 prior data suggests that this shared decision making intervention is safe for patients with rheumatoid arthritis?

Research has shown that shared decision-making in rheumatoid arthritis (RA) care is safe for patients. Studies have found that training doctors to communicate better, a key part of this approach, is well-received and poses little risk. This training enhances understanding between doctors and patients, leading to improved care.

Encouraging patients to take an active role in their treatment, known as patient activation, is also safe. Evidence suggests that when patients are more involved, they usually experience better health outcomes without added risks.

The RA Medication Summary Guide and RA Choice tools help patients understand their treatment options. These tools are based on well-known medications like methotrexate, which has proven to be safe and effective for treating RA.

Overall, this approach to RA care is considered safe and focuses on improving communication and decision-making between patients and healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on enhancing shared decision-making between patients and clinicians in managing rheumatoid arthritis (RA). Unlike traditional treatments that focus purely on medication, this approach trains clinicians in effective communication and empowers patients with tools like the RA Medication summary guide and RA Choice. By fostering better communication and patient involvement, the trial aims to improve treatment outcomes and patient satisfaction, potentially setting a new standard for personalizing RA care.

What evidence suggests that this trial's interventions could be effective for rheumatoid arthritis?

Research has shown that involving patients with rheumatoid arthritis (RA) in treatment decisions can be very effective. Studies have found that this involvement helps patients better understand their condition and adhere to their medication plan, leading to improved health and fewer doctor visits. Additionally, when patients take a more active role in their care, they often achieve better symptom control. In this trial, the RA Medication Summary Guide and RA Choice are part of the intervention arm, providing patients with clear information about their treatment options. This support helps them make informed decisions and may reduce RA symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

Jennifer Barton, MD

Principal Investigator

VA Portland Health Care System, Portland, OR

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482761/

Implementation of shared decision making in rheumatoid ... A pilot study aimed at testing the effectiveness of a low literacy, multilingual decision aid for RA (RA Choice) demonstrated improved knowledge ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05530694?cond=Arthritis&aggFilters=status:rec&country=United%20States&locStr=United%20States&viewType=Table&rank=7

Rheumatoid Arthritis Shared Decision Making 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7590370/

New galaxies in the universe of shared decision making and ... Implementing shared decision making (SDM) is a top international priority to improve care for persons living with rheumatoid arthritis.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0049017224000726

Development and evaluation of shared decision-making ... This is the first scoping review focusing on the development and evaluation of SDM tools in rheumatology.

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05530694

Rheumatoid Arthritis Shared Decision Making 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 ...

6. jrheum.org jrheum.org/content/47/2/290.tab-references

The Development and Evaluation of Personalized Training ... A shared decision-making communication training program for physicians treating fibromyalgia patients: effects of a randomized controlled trial.