Medical Education for Better Multiple Sclerosis Outcomes

NCT03134794 | Completed

• 1 other identifier: REB 15-340
• Study Type: interventional
• Target: 90
• Locations: 4 countries
• Sites: 4

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.

Conditions

Multiple Sclerosis

Keywords

neuroeconomics; multiple sclerosis; educational intervention; traffic light system; aversion to ambiguity; risk; outcomes; knowledge; action; gaps; disease modifying agents

Outcome Measures

Primary Outcomes (3)

• 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

  At the completion of the study, an estimated total of 60 minutes

• 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.

  At the completion of the study, an estimated total of 60 minutes

• 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).

  Up to 60 min

Secondary Outcomes (3)

• Efficacy of the educational intervention

  At the completion of the study, approximately 60 minutes

• Scale (based on the experiment on ambiguity aversion)

  At the completion of the study, approximately 60 minutes

• Scale (physician reaction to uncertainty)

  At the completion of the study, approximately 60 minutes

Study Arms (2)

Educational Intervention

EXPERIMENTAL

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)

Control

NO INTERVENTION

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

Interventions

Educational intervention applying the traffic light system (TLS) BEHAVIORAL

The TLS emerged to facilitate consumers' decisions. It has been applyied in medical decision making.

Educational Intervention

Eligibility Criteria

• Age: 23 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Roche Pharma AG: collaborator

Study Sites (4)

INEBA

Buenos Aires, Buenos Aires F.D., 1642, Argentina

Location

St Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Clinica Las Condes

Santiago, Chile

Location

Espacio GV30

Madrid, Spain

Location

Related Publications (7)

• 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.

  PMID: 27809908 RESULT

• 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.

  PMID: 27146451 RESULT

• 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.

  PMID: 28203061 RESULT

• 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.

  PMID: 28298899 RESULT

• 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.

  PMID: 31259250 RESULT

• 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.

  PMID: 33326024 DERIVED

• 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.

  PMID: 28871238 DERIVED

Related Links

• Decision-making in Multiple Sclerosis: The Role of Aversion to Ambiguity for Therapeutic Inertia among Neurologists (DIScUTIR MS)

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gustavo Saposnik

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: May 1, 2017
• Study Start: March 22, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); AR (1); CA (1); ES (1)