NCT04035720

Decision Making in Multiple Sclerosis Care Under Uncertainty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 23 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Therapeutic inertia (TI) is a common phenomenon in MS care defined as lack of treatment initiation or escalation (e.g. switch interferons or glatiramer to fingolimod /alemtuzumab /natalizumab/ocrelizumab/ etc.) when recommended by guidelines or evidence of disease progression. This phenomenon leads to poorer patient's outcomes, greater disability, and diminished quality of life. Goals of the study: i) to determine what are the most relevant factors influencing therapeutic decisions among neurologists with expertise in MS care; ii) to asses whether physicians rely on medical information provided in a case scenario versus a quantitative or qualitative estimation of disease progression based on hypothetical models.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Quantitative risk	Participants will be able to see a square box that represent the estimated risk of disease progression. They will have to elect making a therapeutic decision based on the description of the case-scenario or based on the estimated prediction as represented in the square box.

Timeline

• Start date: 2019-07-06
• Primary completion: 2021-07-21
• Completion: 2021-12-22
• First posted: 2019-07-29
• Last updated: 2019-07-29

Locations

1 site across 1 country: Canada