Multiple Sclerosis Clinical Trial
— EDUCAR MSOfficial title:
Decision Making Under Uncertainty in MS Care: an Innovative Educational Intervention Applying Concepts From Neuroeconomics
Verified date | October 2020 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 30, 2018 |
Est. primary completion date | October 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 23 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Argentina | INEBA | Buenos Aires | Ciudad De Buenos Aires |
Canada | St Michael's Hospital | Toronto | Ontario |
Chile | Clinica Las Condes | Santiago | |
Spain | Espacio GV30 | Madrid |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Roche Pharma AG |
Argentina, Canada, Chile, Spain,
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):2381468319855 — View 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. eC — View 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. Review. — View 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/fne — View 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/s — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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). | At the completion of the study, approximately 60 minutes | |
Secondary | 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. | At the completion of the study, approximately 60 minutes | |
Secondary | Scale (physician reaction to uncertainty) | Using the 'physicians reaction to uncertainty" instrument as a continuous variable and median split. | At the completion of the study, approximately 60 minutes |
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