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Medical Education for Better Multiple Sclerosis Outcomes (EDUCAR MS)

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ClinicalTrials.gov Identifier: NCT03134794
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : October 19, 2020
Roche Pharma AG
Information provided by (Responsible Party):
Unity Health Toronto

Brief Summary:

The main objectives of this study are:

i) To design an educational tool to train physicians in overcome cognitive factors associated with therapeutic inertia.

ii) To determine the feasibility and efficacy of an educational tool to overcome therapeutic inertia among neurologists caring for MS patients

iii) identify the best strategy to disseminate an educational program to train physicians taking into account regional and practice variations.

iv) To explore whether multiple sclerosis (MS) patients' risk category influence the incidence of therapeutic inertia in neurologists that may require a segmentation strategy in medical education.

v) To assess how participants handle uncertainty when making treatment decisions by measuring pupil variation from baseline (Canadian study).

vi) To evaluate the effect of the TLS on TI by assessing differences pupil variability between the intervention and control groups (Canadian study).

A multicenter, randomized, study including an educational intervention (applying the traffic light system) to overcome therapeutic inertia in MS care.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Educational intervention applying the traffic light system (TLS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Decision Making Under Uncertainty in MS Care: an Innovative Educational Intervention Applying Concepts From Neuroeconomics
Actual Study Start Date : March 22, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Educational Intervention

Education intervention using the TLS. The active group will received an educational intervention applying proven concepts in medical education (cognitive reflection/checklist, traffic light system (TLS). Previous research showed that TL food labels prompted individuals to consider their health and to make healthier choices. A color-coded system influences the valuation process in favor of healthier choices by interfering with automatic decisions and triggering the re-evaluation process (Ena, Krajbich et al Judgement and DM 2016).

The TLS is being implemented to facilitate the identification of patients at risk of developing a clinical and radiological progression that could result in escalation of therapy.

Behavioral: Educational intervention applying the traffic light system (TLS)
The TLS emerged to facilitate consumers' decisions. It has been applyied in medical decision making.

No Intervention: Control
Usual Care. The control group will make therapeutic decisions without being exposed to the educational intervention as part of the current standard practice.

Primary Outcome Measures :
  1. Feasibility of the educational intervention [ Time Frame: At the completion of the study, an estimated total of 60 minutes ]
    defined as the proportion of participants in the educational intervention who selected the 'red" traffic light for high risk cases. It is expected a 70% or higher proportion of correct responses

  2. The proportion of participants who exhibit therapeutic inertia [ Time Frame: At the completion of the study, an estimated total of 60 minutes ]

    defined as lack of treatment escalation when the goals of care are unmet based on best practice guidelines.

    We will compare the total number of responses between groups post-intervention (total number of responses that met the TI criteria over total number of questions answered per participant.

  3. Pupil dilation from baseline (Primary outcome of the study conducted in Canada) [ Time Frame: Up to 60 min ]
    Pupil time-series were z-scored within each participant, to allow comparison of pupil dilation between and within simulated case-scenarios, critical time-periods, and participants. Pupil data will be analyzed as a continuous (mean maximum peak minus mean baseline and mean pupil size minus mean baseline) and dichotomized to reflect phasic and tonic arousal responses (mean maximum-peak minus mean-baseline greater than or equal to 0.1 z-scored difference as a high arousal vs. below 0.1 z-scored difference -low arousal response).

Secondary Outcome Measures :
  1. Efficacy of the educational intervention [ Time Frame: At the completion of the study, approximately 60 minutes ]
    Difference in the proportion of participants with decision fatigue between groups (measured as the difference between proportion of cases with therapeutic inertia post-intervention minus proportion of cases with therapeutic inertia pre-intervention).

  2. Scale (based on the experiment on ambiguity aversion) [ Time Frame: At the completion of the study, approximately 60 minutes ]
    association between ambiguity and risk aversion (independent variables) with therapeutic decisions. Ambiguity aversion is defined as a preference for known risks over unknown risks. This can be elicited through the experiments in the health and financial domains.

  3. Scale (physician reaction to uncertainty) [ Time Frame: At the completion of the study, approximately 60 minutes ]
    Using the 'physicians reaction to uncertainty" instrument as a continuous variable and median split.

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Ages Eligible for Study:   23 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Practicing neurologists and MS specialists caring for patients with MS
  2. Clinical setting: academic or community institutions
  3. Certified physicians in their specialty
  4. Online consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134794

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Buenos Aires, Ciudad De Buenos Aires, Argentina, 1642
Canada, Ontario
St Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
Clinica Las Condes
Santiago, Chile
Espacio GV30
Madrid, Spain
Sponsors and Collaborators
Unity Health Toronto
Roche Pharma AG
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Principal Investigator: Gustavo Saposnik University of Toronto
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT03134794    
Other Study ID Numbers: REB 15-340
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Health Toronto:
multiple sclerosis
educational intervention
traffic light system
aversion to ambiguity
disease modifying agents
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases