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.
Licensed to practice pediatric rheumatology in Canada;
Providing care for children with JIA at least once a month;
Consent to be randomized and to implement the SDM intervention for the duration of the trial, if randomized to the intervention arm;
Commit to propose enrollment in the Registry to all their newly diagnosed patients with JIA during the trial.
None
Parallel
Shared Decision Making (SDM)
Other interventionThe 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.
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).
Proportion of children with Inactive or Minimally Active Disease at 12 months.
Proportion of patients attaining inactive or minimally active disease within 12 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). The comparison at 6 months and at 12 months will be done using a mixed-effects logistic regression model that accounts for the clustering of patients by physician, the paired randomization to intervention or control, the JIA category and the three cJADAS10 components.
Change in Parent-Reported Health-Related Quality of Life
Mean change in parent-reported health-related quality of life (QoL), assessed according to the Juvenile Arthritis Quality of Life Questionnaire (JAQQ). JAQQ scores go from 1=best to 7=worst.
Change in Patient-Reported Health-Related Quality of Life
Mean change in patient-reported health-related quality of life (QoL), assessed according to the Quality of my Life Scale, unless parents state the patient is too young to answer the questionnaire. Scores go from 0=worst to 10=best.
Change in cJADAS10 score
Mean change on the clinical Juvenile Arthritis Disease Activity Score with 10 joints (cJADAS10) and its components. Scores go from 0=best 30=worst.
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University of British Columbia
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
The Arthritis Society, Canada
Collaborator
