Shared Decision Making for Juvenile Arthritis

(PERSON-JIA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Lori B Tucker, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of British Columbia

Must not be taking: Systemic corticosteroids, DMARDs

Disqualifiers: Systemic arthritis, Language barrier, others

No Placebo Group

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

BC Children's Hospital Vancouver, Canada

Who Is Running the Clinical Trial?

University of British Columbia Lead Sponsor

The Arthritis Society, Canada Collaborator

Canadian Institutes of Health Research (CIHR) Collaborator

References

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

Understanding treatment decision making in juvenile idiopathic arthritis: a qualitative assessment. [2021] The increase in therapeutic options for juvenile idiopathic arthritis (JIA) has added complexity to treatment decisions. Shared decision making has the potential to help providers and families work together to choose the best possible option for each patient from the array of choices. As part of a needs assessment, prior to design and implementation of shared decision making interventions, we conducted a qualitative assessment of clinicians' current approaches to treatment decision making in JIA.

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] Juvenile idiopathic arthritis (JIA) is a common pediatric rheumatic condition and is associated with symptoms such as joint pain that can negatively impact health-related quality of life. To effectively manage pain in JIA, young people, their families, and health care providers (HCPs) should be supported to discuss pain management options and make a shared decision. However, pain is often under-recognized, and pain management discussions are not optimal. No studies have explored decision-making needs for pain management in JIA using a shared decision making (SDM) model. We sought to explore families' decision-making needs with respect to pain management among young people with JIA, parents/caregivers, and HCPs.

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

Design and implementation of a decision aid for juvenile idiopathic arthritis medication choices. [2022] Randomized trials have demonstrated the efficacy of patient decision aids to facilitate shared decision making in clinical situations with multiple medically reasonable options for treatment. However, little is known about how best to implement these tools into routine clinical practice. In addition, reliable implementation of decision aids has been elusive and spread within pediatrics has been slow. We sought to develop and reliably implement a decision aid for treatment of children with juvenile idiopathic arthritis.

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] Shared decision-making is an approach to making treatment-based decisions that rely on the patient encounter and clear discussions between the patient and the healthcare provider. Patients with arthritis of the knee frequently seek care, and depending on arthritis severity and impact on daily life, joint arthroplasty may be considered as a treatment option. We will conduct a systematic review of shared decision-making trials in knee arthroplasty to determine the types of shared decision-making approaches used and their impact on care received.

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

Is sharing really caring? Viewpoints on shared decision-making in paediatrics. [2021] Shared decision-making (SDM), the cornerstone of family-centred care and the gold standard in health decision-making, occurs when the patient, family members and the health-care team members partner to make health decisions about the child. This partnership involves an exchange of medical information and information about patient/family preferences and values. Together, the health-care team, parent and patient deliberate to determine the best course of action for the child. Despite high-quality evidence supporting its positive impact on outcomes, SDM has not been widely adopted in paediatric clinical practice. Greater understanding of the impact of SDM on all members of the decision triad (parent, patient and health-care provider) may increase the likelihood of SDM adoption. Therefore, we present the viewpoints of a paediatric patient, parent and paediatrician about the use of SDM. A youth living with a rare chronic disease discusses the impacts of being involved and excluded from health decisions. A mother of a son living with a rare nephrotic condition discusses working with a health-care team who are committed and skilled in SDM and the positive impacts SDM has had for her son's care. A general paediatrician with research expertise in SDM discusses the individual and system level challenges and rewards of using SDM in her clinical practice. Based on the viewpoints presented, we offer pragmatic recommendations for using SDM in paediatric clinical practice.

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

Shared Decision-Making Applied to Knee Arthroplasty: A Systematic Review of Randomized Trials. [2021] Shared decision-making (SDM) is a strongly endorsed approach by which patients and clinicians work together to formulate a sensible care plan. The present study was undertaken to conduct a systematic review of SDM trials in patients considering knee arthroplasty (KA) to characterize how SDM was supported and the impact on care received.

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

Barriers and facilitators of pediatric shared decision-making: a systematic review. [2023] Shared decision-making (SDM) is rarely implemented in pediatric practice. Pediatric health decision-making differs from that of adult practice. Yet, little is known about the factors that influence the implementation of pediatric shared decision-making (SDM). We synthesized pediatric SDM barriers and facilitators from the perspectives of healthcare providers (HCP), parents, children, and observers (i.e., persons who evaluated the SDM process, but were not directly involved).

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

New galaxies in the universe of shared decision-making and rheumatoid arthritis. [2022] Implementing shared decision-making (SDM) is a top international priority to improve care for persons living with rheumatoid arthritis. Using SDM tools, such as decision aids improve patients' knowledge and support communication with their clinicians on treatment benefits and risks. Despite calls for SDM in treat-to-target, studies demonstrating effective SDM strategies in rheumatology clinical practice are scarce. Our objective was to identify recent and relevant literature on SDM in rheumatoid arthritis.