Decision Making in Multiple Sclerosis Care Under Uncertainty
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Accuracy of treatment decisions
研究概览
简要总结
The main objectives of this study are:
i) To determine patient-level, physician-level and health system factors influencing therapeutic decisions in multiple sclerosis (MS) care by applying conjoint discrete experiments.
ii) To determine the prevalence of therapeutic inertia among participating neurologists.
iii) To compare clinical judgement vs. a qualitative or quantitative approach when assessing for a given case-scenario.
iv) To evaluate the influence of decision fatigue in treatment decisions.
详细描述
The landscape of MS care is changing. Currently, there are over 15 disease modifying agents (DMTs) available to treat MS, with varying availability around the world.
Significant heterogeneity exists in the efficacy and risks associated with these therapies.
Neurologists caring for MS patients face important choices in each medical encounter: 1) continue with the same management, 2) initiate or escalate therapy for a more effective or safer agent, or 3) consider a reassessment within months under the uncertainty of the current status of the patient.
Limited information on how physicians weigh in different factors when making therapeutic decisions.
Physicians (cognitive biases affecting decision making) and health system (e.g. access to an infusion center) factors are the most responsible causes of practice gaps in MS care. The physician's component is the least studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 23 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Actively practicing neurologist
- •Expertise in treating patients with multiple sclerosis (at least 12 per year)
- •Clinical setting: academic or community institutions, private practice or outpatient clinic
- •Certified physicians in their specialty
- •Online consent to participate in the study
排除标准
- 未提供
研究组 & 干预措施
Quantitative risk estimation
Participants will be exposed to case-scenarios. Each case scenario provides a description of the current clinical situation (e.g. patient age, current treatment, number of relapses, current EDSS, MRI findings, etc). In addition, participants will see a squared box indicating the probability of risk progression (20%, 25%, 85%, 90%). This information may or may not be accurate to reflect potential errors of risk prediction tools.
干预措施: Quantitative risk (Other)
Qualitative risk estimation
Participants will be exposed to the same case-scenarios as the intervention arm. Each case scenario provides a description of the current clinical situation (e.g. patient age, current treatment, number of relapses, current EDSS, MRI findings, etc). In addition, participants will see a squared box indicating a qualitative probability of risk progression (low, high). This information may or may not be accurate to reflect potential errors of risk prediction tools.
干预措施: Quantitative risk (Other)
结局指标
主要结局
Accuracy of treatment decisions
时间窗: At the completion of the study, an estimated 90 minutes
Comparison of discordant pairs in each arm: Using chi-square (parametric) test, there will be a comparison between groups (intervention vs. control) in the proportion of participants who made accurate therapeutic decisions.
Therapeutic inertia score
时间窗: At the completion of the study, an estimated 90 minutes
The therapeutic inertia (TI) score is based on our previous work published elsewhere (see references). It is based on the sum number of case-scenarios that required treatment escalation over the total number of presented scenarios (10). Range: 0 (lowest value) to 10 (maximal value). The higher value represents the higher level of therapeutic inertia. There is no subscale. This measurement has been previously reported (Saposnik et al. JAMA Netw Open. 2019 Jul 3;2(7):e197093. doi: 10.1001/jamanetworkopen.2019.7093; Saposnik et al. MDM Policy Pract. 2019 Jun 21;4(1):2381468319855642. doi: 10.1177/2381468319855642)
次要结局
- Therapeutic decisions under fatigue(At the completion of the study, an estimated 90 minutes)
- Prevalence of therapeutic inertia (TI)(At the completion of the study, an estimated 90 minutes)
- Factors associated with therapeutic decisions(At the completion of the study, an estimated 90 minutes)