Clinical trial NCT04035720: Decision Making in Multiple Sclerosis Care Under Uncertainty
Official title: Decision Making in Multiple Sclerosis Care Under Uncertainty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: decision making
therapeutic
disease modifying agents
monoclonal antobodies
physicians
neurologists
uncertainty
neuroeconomics
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: University of Toronto
First posted: 2019-07-29
Enrollment: 450
Sex: ALL
Minimum age (years): 23
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Therapeutic inertia score
timeFrame: At the completion of the study, an estimated 90 minutes
measure: Accuracy of treatment decisions
timeFrame: At the completion of the study, an estimated 90 minutes
Secondary outcomes:
measure: Therapeutic decisions under fatigue
timeFrame: At the completion of the study, an estimated 90 minutes
measure: Prevalence of therapeutic inertia (TI)
timeFrame: At the completion of the study, an estimated 90 minutes
measure: Factors associated with therapeutic decisions
timeFrame: At the completion of the study, an estimated 90 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Gustavo Saposnik, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saposnik G, Sempere AP, Prefasi D, Selchen D, Ruff CC, Maurino J, Tobler PN. Decision-making in Multiple Sclerosis: The Role of Aversion to Ambiguity for Therapeutic Inertia among Neurologists (DIScUTIR MS). Front Neurol. 2017 Mar 1;8:65. doi: 10.3389/fneur.2017.00065. eCollection 2017.