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

Trial Summary

What is the purpose of this trial?

The PERSON-JIA Trial is a cluster-randomized trial testing the use of Shared Decision Making (SDM) with families for treatment of children with arthritis. The intervention is a discussion between physicians and families at the time of diagnosis that uses computer-generated personalized outcome reports generated by previously developed prediction algorithms. By using information provided by thousands of families, the investigators have developed a way of providing answers to common questions asked by patients and their families at diagnosis. We will test whether a structured discussion and shared decision between families and doctors (guided by the patient's personal report) will improve the tailoring of treatment to the child and control of their disease. The personal report is called the PERSON-JIA report and presents the child's expected disease severity, the likelihood the child will be arthritis free by age 18 and the chance treatments will be effective and/or have side effects. This way, answers to these questions can be shared by physicians and families to weigh potential benefits and harms according to family values and preferences. The investigators expect that using the personalized report in a frank and thoughtful discussion will help physicians and families make better decisions about managing the child's disease. This in turn will result in better disease control, greater family engagement and satisfaction with care and better-tailored treatment. If so, this will be a ground-breaking way of using information provided by families and doctors to improve the care provided to and the outcomes of children with arthritis in Canada.

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 data supports the effectiveness of the treatment Shared Decision Making (SDM) for Juvenile Arthritis?

Research shows that shared decision making (SDM) can improve health outcomes by involving patients and families in treatment choices, which is especially important in conditions like juvenile arthritis where multiple treatment options exist. Although specific studies on SDM for juvenile arthritis are limited, SDM has been shown to be effective in other areas of pediatric care, suggesting it could be beneficial here as well. ^{1 2 3 4 5}

Is shared decision making safe for use in humans?

Shared decision making (SDM) is a widely endorsed approach in healthcare where patients, families, and healthcare providers work together to make health decisions. It is considered safe as it involves communication and collaboration rather than medical interventions, and there is no evidence suggesting any harm from its use. ^{1 2 3 5 6}

How is the Shared Decision Making treatment different from other treatments for juvenile arthritis?

Shared Decision Making (SDM) is unique because it involves patients, families, and healthcare providers working together to make treatment decisions, considering both medical information and personal preferences. This collaborative approach is different from traditional methods where decisions are often made solely by healthcare providers. ^{1 2 5 7 8}

Research Team

Lori B Tucker, MD

Principal Investigator

University of British Columbia Department of Pediatrics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

Understanding treatment decision making in juvenile idiopathic arthritis: a qualitative assessment. [2021]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Design and implementation of a decision aid for juvenile idiopathic arthritis medication choices. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Protocol for a systematic review of randomized trials of knee arthroplasty decision aids and shared decision-making approaches. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Is sharing really caring? Viewpoints on shared decision-making in paediatrics. [2021]

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

Shared Decision-Making Applied to Knee Arthroplasty: A Systematic Review of Randomized Trials. [2021]

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

Barriers and facilitators of pediatric shared decision-making: a systematic review. [2023]

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

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