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Medical Education for Better Multiple Sclerosis Outcomes (EDUCAR MS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Educational intervention applying the traffic light system (TLS)
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring neuroeconomics, multiple sclerosis, educational intervention, traffic light system, aversion to ambiguity, risk, outcomes, knowledge, action, gaps, disease modifying agents

Eligibility Criteria

23 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • INEBA
  • St Michael's Hospital
  • Clinica Las Condes
  • Espacio GV30

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational Intervention

Control

Arm Description

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.

Usual Care. The control group will make therapeutic decisions without being exposed to the educational intervention as part of the current standard practice.

Outcomes

Primary Outcome Measures

Feasibility of the educational intervention
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
The proportion of participants who exhibit therapeutic inertia
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.
Pupil dilation from baseline (Primary outcome of the study conducted in Canada)
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

Efficacy of the educational intervention
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).
Scale (based on the experiment on ambiguity aversion)
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.
Scale (physician reaction to uncertainty)
Using the 'physicians reaction to uncertainty" instrument as a continuous variable and median split.

Full Information

First Posted
March 5, 2017
Last Updated
October 16, 2020
Sponsor
Unity Health Toronto
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT03134794
Brief Title
Medical Education for Better Multiple Sclerosis Outcomes
Acronym
EDUCAR MS
Official Title
Decision Making Under Uncertainty in MS Care: an Innovative Educational Intervention Applying Concepts From Neuroeconomics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Roche Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The goal of the present study is the application of an educational intervention (based on best clinical practices) to reduce therapeutic inertia targeting neurologists caring for MS patients. The investigators are also interested in evaluating whether an education intervention decreases TI by reducing arousal response (pupil dilation), a proxy measure of how physicians respond to uncertainty during treatment decisions. A secondary goal is to improve physicians' tolerance to uncertainty, which has been directly related to therapeutic inertia in our previous studies. This proposal follows the results of our study that identified factors associated with management errors and therapeutic inertia by applying novel concepts and validated experiments from Behavioral economics/ Neuroeconomics. Rationale for the current study: Physicians have limited education in risk management and formal training in decision making. Only a small proportion of MS patients are being treated according to the best clinical practice guidelines. 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 (Blum). In a previous study (JURaSSiC), physicians have shown poor estimation of the prognosis of stroke patients. As this not unique to a single neurological condition and directly affects the recognition of patients who would benefit from escalating therapies. Therapeutic inertia (TI) is a common phenomenon in medicine defined as lack of treatment escalation when recommended according to the best practice guidelines. This phenomenon lead to poorer patients outcomes, greater disability, and diminished quality of life. In a recent study conducted by our group including 136 neurologists and MS experts, the investigators found TI was present in nearly 7 out of 10 (68.8%) of participants. Similar results were observed for criteria of disease progression. Aversion to ambiguity (situation when risk are unknown) and low tolerance to uncertainty were the stronger predictors of TI among neurologists caring for MS patients. Although risk prognostic tools (e.g. EMA, modified Rio, clinical+radiological progression) are available to assist physicians in stratifying patients, it is not known whether or not neurologists use a systematic approach to improve the therapeutic decisions in MS care. There is a limited understanding on how to ameliorate the physicians' factors (e.g. low tolerance to uncertainty, aversion to ambiguity, etc) associated with TI, which leads to worse clinical outcomes and poor quality of life. Some strategies has been proposed to reduce the effects cognitive factors and biases on clinical decisions. A comprehensive narrative review comprising 41 studies on cognitive interventions to reduce misdiagnosis found three main effective strategies: increasing knowledge and expertise, improving clinical reasoning, and getting help from colleagues, experts and tools.18 First, reflective reasoning counteracts the impact of cognitive biases by improving diagnostic accuracy in second- (OR 2.03; 95%CI, 1.49-2.57) and first-year residents [OR (odds ratio) 2.31; 95% CI, 1.89-2.73].19 Second, the implementation of tools (e.g. cognitive checklist, calibration) may overcome overconfidence, the anchoring and framing effects (figure 5).20-22 Third, heuristics approaches (shortcuts to ignore less relevant information to overcome the complexity of some clinical situations) can improve decision making. As shown by Marewski and Gigerenzer, the identification of three rules (search for predictors to determine their individual importance, stop searching when relevant information was already obtained, and a criteria that specify how a decision is made) may facilitate prompt decisions and may help physicians to avoid errors in some clinical situations. The inclusion of training in cognitive biases in graduate and postgraduate programs might foster medical education and thereby improve health care delivery. In summary, a new arsenal of disease-modifying agents became available in the last few decades (and more will be approved in the next three years), but over half of neurologists caring for MS patients do not escalate therapy when indicated by clinical best practices. As such, physicians' decision-making process and access to new effective DMTs became the current bottleneck in MS care. Physicians' factors that are directly associated with therapeutic inertia in MS care. The investigators propose to creating and testing an intervention or tool to train physicians to overcome biases, implement more standardized therapeutic approaches, which will lead to reducing the incidence of TI and better MS outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
neuroeconomics, multiple sclerosis, educational intervention, traffic light system, aversion to ambiguity, risk, outcomes, knowledge, action, gaps, disease modifying agents

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care. The control group will make therapeutic decisions without being exposed to the educational intervention as part of the current standard practice.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention applying the traffic light system (TLS)
Intervention Description
The TLS emerged to facilitate consumers' decisions. It has been applyied in medical decision making.
Primary Outcome Measure Information:
Title
Feasibility of the educational intervention
Description
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
Time Frame
At the completion of the study, an estimated total of 60 minutes
Title
The proportion of participants who exhibit therapeutic inertia
Description
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.
Time Frame
At the completion of the study, an estimated total of 60 minutes
Title
Pupil dilation from baseline (Primary outcome of the study conducted in Canada)
Description
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).
Time Frame
Up to 60 min
Secondary Outcome Measure Information:
Title
Efficacy of the educational intervention
Description
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).
Time Frame
At the completion of the study, approximately 60 minutes
Title
Scale (based on the experiment on ambiguity aversion)
Description
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.
Time Frame
At the completion of the study, approximately 60 minutes
Title
Scale (physician reaction to uncertainty)
Description
Using the 'physicians reaction to uncertainty" instrument as a continuous variable and median split.
Time Frame
At the completion of the study, approximately 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Practicing neurologists and MS specialists caring for patients with MS Clinical setting: academic or community institutions Certified physicians in their specialty Online consent to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Saposnik
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
INEBA
City
Buenos Aires
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
Facility Name
Clinica Las Condes
City
Santiago
Country
Chile
Facility Name
Espacio GV30
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27809908
Citation
Saposnik G, Redelmeier D, Ruff CC, Tobler PN. Cognitive biases associated with medical decisions: a systematic review. BMC Med Inform Decis Mak. 2016 Nov 3;16(1):138. doi: 10.1186/s12911-016-0377-1.
Results Reference
result
PubMed Identifier
27146451
Citation
Saposnik G, Sempere AP, Raptis R, Prefasi D, Selchen D, Maurino J. Decision making under uncertainty, therapeutic inertia, and physicians' risk preferences in the management of multiple sclerosis (DIScUTIR MS). BMC Neurol. 2016 May 4;16:58. doi: 10.1186/s12883-016-0577-4.
Results Reference
result
PubMed Identifier
28203061
Citation
Saposnik G, Maurino J, Sempere AP, Ruff CC, Tobler PN. Herding: a new phenomenon affecting medical decision-making in multiple sclerosis care? Lessons learned from DIScUTIR MS. Patient Prefer Adherence. 2017 Jan 31;11:175-180. doi: 10.2147/PPA.S124192. eCollection 2017.
Results Reference
result
PubMed Identifier
28298899
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.
Results Reference
result
PubMed Identifier
31259250
Citation
Saposnik G, Mamdani M, Montalban X, Terzaghi M, Silva B, Saladino ML, Tobler PN, Caceres F. Traffic Lights Intervention Reduces Therapeutic Inertia: A Randomized Controlled Trial in Multiple Sclerosis Care. MDM Policy Pract. 2019 Jun 21;4(1):2381468319855642. doi: 10.1177/2381468319855642. eCollection 2019 Jan-Jun.
Results Reference
result
PubMed Identifier
33326024
Citation
Saposnik G, Grueschow M, Oh J, Terzaghi MA, Kostyrko P, Vaidyanathan S, Nisenbaum R, Ruff CC, Tobler PN. Effect of an Educational Intervention on Therapeutic Inertia in Neurologists With Expertise in Multiple Sclerosis: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2022227. doi: 10.1001/jamanetworkopen.2020.22227.
Results Reference
derived
PubMed Identifier
28871238
Citation
Saposnik G, Maurino J, Sempere AP, Terzaghi MA, Ruff CC, Mamdani M, Tobler PN, Montalban X. Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education. Front Neurol. 2017 Aug 21;8:430. doi: 10.3389/fneur.2017.00430. eCollection 2017.
Results Reference
derived
Links:
URL
http://journal.frontiersin.org/article/10.3389/fneur.2017.00065/full
Description
Decision-making in Multiple Sclerosis: The Role of Aversion to Ambiguity for Therapeutic Inertia among Neurologists (DIScUTIR MS)

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Medical Education for Better Multiple Sclerosis Outcomes

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