Personalized Estimates of Response and Severity Outcomes in Newly-diagnosed JIA

NCT05310799 | Recruiting DMC

• 1 other identifier: H21-00593
• Study Type: interventional
• Target: 842
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile idiopathic arthritis; Arthritis, Juvenile; Arthritis; Shared decision making; Clinical outcomes; Canada; PERSON-JIA; PERSON JIA

Outcome Measures

Primary Outcomes (1)

• Proportion of children with Inactive or Minimally Active Disease at 6 months.

  Proportion of patients attaining inactive or minimally active disease within 6 months of study enrollment, defined as a cJADAS (Clinical Juvenile Arthritis Disease Activity Score 10) of 2.5 or less for patients with \>4 joints involved and 1.5 or less for patients with 1-4 joints involved. The cJADAS10 is the sum of the number of active joints (to a maximum of 10), the Physician Assessment of Disease Activity (PGADA 0 to 10), and the Parent Global Assessment of well-being (0-10).

  6 months after enrollment

Secondary Outcomes (11)

• Proportion of children with Inactive or Minimally Active Disease at 12 months.

  12 months after enrollment

• Change in Parent-Reported Health-Related Quality of Life

  From enrollment to 6 and 12 months

• Change in Patient-Reported Health-Related Quality of Life

  From enrollment to 6 and 12 months

• Change in cJADAS10 score

  From enrollment to 6 and 12 months

• Change in functional impairment

  From enrollment to 6 and 12 months

Study Arms (2)

Current Best Practice

NO 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.

Shared Decision Making (SDM)

EXPERIMENTAL

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.

Other: Shared Decision Making (SDM)

Interventions

Shared Decision Making (SDM) OTHER

The intervention is a structured SDM discussion between physician and family, occurring at the time of the child's JIA diagnosis and clinic visit. Discussion will be guided by a discussion guide and the PERSON-JIA Report, which is generated in real time on the physician's smart phone.

Shared Decision Making (SDM)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Physicians (Inclusion): 1. Licensed to practice pediatric rheumatology in Canada; 2. Providing care for children with JIA at least once a month; 3. Consent to be randomized and to implement the SDM intervention for the duration of the trial, if randomized to the intervention arm; 4. Commit to propose enrollment in the Registry to all their newly diagnosed patients with JIA during the trial. Physicians (Exclusion): 1. Fellows-in-training; 2. Physicians planning to retire within 2 years. Patient (Inclusion): 1. Consent to include their information in the CAPRI JIA Registry; 2. Consent to the PERSON-JIA trial and answering additional questionnaires to assess decision making; 3. Allow recording of their medical encounter (if selected at random); 4. JIA fulfilling International League of Associations for Rheumatology (ILAR) criteria; 5. Newly diagnosed (within the last month); 6. Diagnosed by a pediatric rheumatologist participating in the PERSON-JIA study; 7. Not yet receiving treatment, or received only Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) or joint injections; Patient (Exclusion): 1. Systemic arthritis category of JIA (it requires a different treatment approach); 2. Family is unable to complete study forms in English or French; 3. Patients who have already started systemic corticosteroid or any Disease Modifying Anti-Rheumatic Drug (DMARD).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Arthritis Society, Canada: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lori B Tucker, MD

  University of British Columbia Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Guzman

CONTACT

604 875 2000; jguzman@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Pediatric Rheumatology

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: April 5, 2022
• Study Start: May 23, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CA (1)