Shared Decision Making for Juvenile Arthritis

(PERSON-JIA Trial)

Overseen By Jaime Guzman

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Systemic corticosteroids, DMARDs

Disqualifiers: Systemic arthritis, Language barrier, others

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

Compensation: Varies

Number of Visits: 4

842 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called Shared Decision Making (SDM) to improve treatment for children with juvenile arthritis. It uses personalized reports to guide discussions between doctors and families, helping them make better decisions tailored to the child's needs. The goal is to improve disease control and family satisfaction by using detailed predictions about the child’s condition and treatment outcomes. Families with a child newly diagnosed with juvenile arthritis, not yet on major treatments, and who can complete forms in English or French might be a good fit for this trial. As an unphased study, this trial offers families the opportunity to actively participate in innovative research that could enhance treatment strategies for juvenile arthritis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have not started systemic corticosteroids or any Disease Modifying Anti-Rheumatic Drug (DMARD) before joining. If you are only on Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or have had joint injections, you may still be eligible.

What prior data suggests that this shared decision-making method is safe for children with juvenile arthritis?

Studies have shown that shared decision-making (SDM) tools are generally easy to use and can help children with juvenile idiopathic arthritis (JIA) and their families better understand treatment options. Research indicates that these tools provide patient-focused information during discussions with doctors, helping everyone grasp the pros and cons of different treatments.

One study created an SDM tool specifically for JIA, which helped children and their families make more informed treatment choices. This approach does not involve taking new medications but focuses on improving decision-making processes. No reports have indicated negative effects from using the SDM process itself. Instead, it aims to make treatment choices more personalized and aligned with family values. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about shared decision making (SDM) for juvenile arthritis because it shifts focus from medication-centered approaches to enhancing communication between doctors, patients, and families. Unlike standard treatments that rely heavily on medication protocols, SDM empowers patients and their families to make informed treatment decisions tailored to their unique circumstances, guided by real-time data from the PERSON-JIA Report. This method fosters a collaborative environment, potentially leading to more personalized care and improved satisfaction with treatment outcomes.

What evidence suggests that Shared Decision Making is effective for juvenile arthritis?

Research has shown that shared decision-making (SDM) in healthcare can be very effective. In this trial, one group of participants will engage in SDM, where patients and doctors collaborate using tools like the PERSON-JIA report. This approach aims to tailor treatment choices to the individual's needs, often leading to better disease control and higher satisfaction with care. For juvenile arthritis, SDM helps families and doctors make informed decisions that align with personal values and expectations. By discussing possible outcomes and treatment effects, families feel more involved and confident in managing the condition. Another group will receive current best practice care without structured SDM discussions. ^{2 5 6 7 8}

Who Is on the Research Team?

Lori B Tucker, MD

Principal Investigator

University of British Columbia Department of Pediatrics

Are You a Good Fit for This Trial?

This trial is for children newly diagnosed with Juvenile Idiopathic Arthritis (JIA), except those with systemic arthritis. They must be diagnosed by a participating pediatric rheumatologist, not yet on treatment or only on NSAIDs/joint injections, and able to complete forms in English or French.

Inclusion Criteria

I have been diagnosed with juvenile idiopathic arthritis according to ILAR criteria.

I was diagnosed with my condition within the last month.

Patients must consent to the PERSON-JIA trial and answering additional questionnaires to assess decision making

Exclusion Criteria

I have systemic juvenile idiopathic arthritis.

Physicians who are Fellows-in-training

Physicians planning to retire within 2 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Treatment Decision

Structured shared decision making discussion using the PERSON-JIA report at the time of diagnosis

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for disease activity and treatment effectiveness

6 months

2 visits (in-person) at 6 and 12 months

Extended Follow-up

Continued monitoring of disease activity and quality of life

12 months

1 visit (in-person) at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Shared Decision Making (SDM)

Trial Overview The PERSON-JIA Trial tests Shared Decision Making (SDM) using personalized outcome reports to guide treatment discussions between doctors and families of children with JIA. It aims to tailor treatments better and improve disease control through informed decisions.

How Is the Trial Designed?

Group I: Shared Decision Making (SDM) Experimental Treatment 1 Intervention

Physicians will use the PERSON-JIA Report to guide discussions with the newly diagnosed patient and family. The intervention will not dictate the use of specific medications or treatment strategies, only facilitate better informed treatment choices according to patient circumstances. The intervention is a structured SDM discussion between physician and family, occurring at the time of the child's JIA diagnosis. Discussion is guided by the PERSON-JIA Report, which is generated in real time, on the physician's smart phone. Patients newly-diagnosed with JIA will be consented to both enrollment in the CAPRI Registry and enrollment in the PERSON-JIA trial. Clinic visit and discussion between the physician, patient and family will be facilitated by the PERSON-JIA report to support a shared decision making process. Questionnaires will be collected at enrollment, at the second visit and at 6-month and 12-month follow-up visits.

Group II: Current Best Practice Active Control 1 Intervention

Physicians randomized to this arm will provide current care and treatment decisions with patients will be made in accordance with current best practices. Will not engage in structured shared decision making (SDM) discussion and will not have access to PERSON-JIA Reports. Patients will be consented to enroll in the CAPRI Registry at the clinic visit when they are diagnosed. Registry enrollment will allow collection and input of clinical data into the Registry. Clinic visit and discussion will remain unchanged for physicians, patients and their families. Questionnaires will be collected at enrollment, at the second visit and a 6-month and 12-month follow-up visits.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

The Arthritis Society, Canada

Collaborator

Trials

27

Recruited

9,700+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

This systematic review aims to evaluate various shared decision-making (SDM) approaches used in randomized trials for knee arthroplasty, focusing on how these methods affect patient care and outcomes.

By analyzing data from multiple databases and ongoing research, the review seeks to identify knowledge gaps in SDM practices, which could inform future research and improve treatment decisions for patients with knee arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a systematic review of randomized trials of knee arthroplasty decision aids and shared decision-making approaches. Riddle, DL., Sando, T., Tarver, T., et al.[2023]

A systematic review of 79 studies identified key barriers to implementing shared decision-making (SDM) in pediatric practice, including insufficient time for healthcare providers, poor quality information, and power imbalances between parents and children.

Facilitators for effective SDM included having good quality information, trust and respect in the healthcare relationship, and the use of SDM tools, highlighting the importance of context-specific strategies to enhance SDM in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators of pediatric shared decision-making: a systematic review. Boland, L., Graham, ID., Légaré, F., et al.[2023]

Shared decision-making (SDM) is crucial in pediatric care, as it involves collaboration between patients, families, and healthcare providers to make informed health decisions, yet it remains underutilized despite evidence of its benefits.

Insights from a pediatric patient, a parent, and a pediatrician highlight the positive impacts of SDM on care outcomes and emphasize the need for practical recommendations to enhance its adoption in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is sharing really caring? Viewpoints on shared decision-making in paediatrics. Jordan, Z., Tremblay, C., Lipstein, E., et al.[2021]

In a study involving 10 pediatric rheumatology clinicians, it was found that treatment decisions for juvenile idiopathic arthritis (JIA) are primarily initiated by clinicians, often reflecting their personal treatment preferences rather than those of the families.

Family preferences play a more significant role in decisions regarding the discontinuation of treatment after symptom remission, highlighting a potential area for improvement in shared decision-making practices in pediatric rheumatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding treatment decision making in juvenile idiopathic arthritis: a qualitative assessment. Lipstein, EA., Brinkman, WB., Sage, J., et al.[2021]

A study involving 12 young people with juvenile idiopathic arthritis (JIA), 13 parents/caregivers, and 11 healthcare providers highlighted the need for better assessment and management of pain in JIA, emphasizing the importance of shared decision-making (SDM) in treatment discussions.

Participants expressed a strong desire for more information on pain management options, particularly nonpharmacological approaches, and indicated that effective communication and decision support could enhance pain management strategies and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I'd like more options!": Interviews to explore young people and family decision-making needs for pain management in juvenile idiopathic arthritis. Toupin-April, K., Gaboury, I., Proulx, L., et al.[2023]

A decision aid for treating children with juvenile idiopathic arthritis was developed with input from patients, parents, and clinicians, and was positively received after 18 rounds of testing.

Despite high user acceptability, the decision aid was only used in 35% of relevant clinical visits, and no significant differences in shared decision making or uncertainty were found between visits with and without the aid, indicating challenges in reliable implementation in routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a decision aid for juvenile idiopathic arthritis medication choices. Brinkman, WB., Lipstein, EA., Taylor, J., 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]

The systematic review identified 6 randomized trials focused on a proprietary decision aid for knee arthroplasty, which improved patient knowledge about treatment options but did not significantly enhance shared decision-making or clinical outcomes.

While one trial noted an increase in African American patients undergoing knee arthroplasty after using the decision aid, overall evidence suggests that the current tools do not effectively support all aspects of shared decision-making or improve patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision-Making Applied to Knee Arthroplasty: A Systematic Review of Randomized Trials. Riddle, DL., Sando, T., Tarver, T., et al.[2021]

Citations

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Outcome Monitoring and Clinical Decision Support in ... We aimed to improve polyarticular JIA [Poly-JIA, rheumatoid factor positive and negative] outcomes by standardizing point-of-care disease activity monitoring.

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Inform Shared Decision Making with Advanced Bayesian ... This research will design, develop, implement, and evaluate the Patient Centered Adaptive Treatment Strategies (PCATS) juvenile idiopathic arthritis (JIA) ...

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Shared decision-making aid for juvenile idiopathic arthritis Conclusions: The developed SDM aid offered the children evidence-based information about the pros and cons of treatment options and improved their understanding ...

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A178: Development of Tools to Facilitate Shared Decision ... A178: Development of Tools to Facilitate Shared Decision Making about Medications for Juvenile Idiopathic Arthritis—A Project of the Pediatric ...