Treating Children With Arthritis According to Their Individual Probability of Outcomes and Response to Treatments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 842
- 试验地点
- 1
- 主要终点
- Proportion of children with Inactive or Minimally Active Disease at 6 months.
研究概览
简要总结
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.
详细描述
The PERSON-JIA (Personalized Estimates of Response and Severity Outcomes in Newly-diagnosed Juvenile Idiopathic Arthritis) trial, will test an innovative shared decision making (SDM) intervention - a structured discussion, between physician and family, of the likely outcomes/response to treatments, as predicted by Personalized Prediction Algorithms (PPA), presented in a graphical summary.
Juvenile Idiopathic Arthritis (JIA) is chronic arthritis of unknown cause starting before the 16th birthday. At present, evidence does not suggest that any single treatment approach for treating JIA is clearly superior, and current practice guidelines recommend Shared Decision Making (SDM) with families to select treatment. SDM requires a realistic appreciation of disease severity along with the likely benefits vs. harms associated with treatment options, and to then weigh these factors according to the family's values and preferences.
To facilitate SDM, the investigators have built and validated PPA using data from previous Canadian JIA cohorts. As compared to treatment algorithms/flowcharts that tell physicians what to do, PPA are mathematical models that calculate the probability of outcomes for a child, based on their clinical presentation.
The investigators have also established a Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) JIA Registry, which supports point of care data entry using smartphones/tablets. After data is entered in the registry for a newly diagnosed patient, PPA produce a graphical report depicting that child's probability of severe disease, remission in adulthood, and response and side effects with different treatments. This randomized controlled trial (RCT) will test the impact on JIA outcome of a SDM intervention that uses this graphical report to better tailor treatment to the child and family.
The investigators hypothesize that compared to current standard care, use of this SDM intervention will lead to improved JIA disease control at 6 months via increased family engagement, greater satisfaction with treatment decisions, optimal tailoring of treatment to the child, and consistent adherence to the treatment plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physicians (Inclusion):
- •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.
- •Physicians (Exclusion):
- •Fellows-in-training;
- •Physicians planning to retire within 2 years.
- •Patient (Inclusion):
- •Consent to include their information in the CAPRI JIA Registry;
- •Consent to the PERSON-JIA trial and answering additional questionnaires to assess decision making;
- •Allow recording of their medical encounter (if selected at random);
- •JIA fulfilling International League of Associations for Rheumatology (ILAR) criteria;
- •Newly diagnosed (within the last month);
- •Diagnosed by a pediatric rheumatologist participating in the PERSON-JIA study;
- •Not yet receiving treatment, or received only Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) or joint injections;
- •Patient (Exclusion):
- •Systemic arthritis category of JIA (it requires a different treatment approach);
- •Family is unable to complete study forms in English or French;
- •Patients who have already started systemic corticosteroid or any Disease Modifying Anti-Rheumatic Drug (DMARD).
排除标准
- 未提供
研究组 & 干预措施
Current Best Practice
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)
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.
干预措施: Shared Decision Making (SDM) (Other)
结局指标
主要结局
Proportion of children with Inactive or Minimally Active Disease at 6 months.
时间窗: 6 months after enrollment
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).
次要结局
- Change in Patient-Reported Health-Related Quality of Life(From enrollment to 6 and 12 months)
- Intervention Fidelity(The first patient enrolled and another selected at random within the next 24 weeks)
- Change in functional impairment(From enrollment to 6 and 12 months)
- Change in Health Utilities(From enrollment to 6 and 12 months)
- Change in cJADAS10 score(From enrollment to 6 and 12 months)
- Parent assessment of decisional conflict(1-3 months)
- Proportion of children receiving recommended treatment(1-3 months)
- 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)
- Parent assessment of decision making(1-3 months)
- Doctor assessment of decision making(1-3 months)
研究者
Lori Tucker
Head, Pediatric Rheumatology
University of British Columbia