Multiple SclerosisEDUCAR MSNCT03134794
Medical Education for Better Multiple Sclerosis Outcomes
A study testing Educational intervention applying the traffic light system (TLS) in people with Multiple Sclerosis, run by Unity Health Toronto at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Educational intervention applying the traffic light system (TLS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 22 Mar 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Decision Making Under Uncertainty in MS Care: an Innovative Educational Intervention Applying Concepts From Neuroeconomics
The main objectives of this study are:
- 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.
- 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Educational intervention applying the traffic light system (TLS)
- Keywords
- neuroeconomics, multiple sclerosis, educational intervention, traffic light system, aversion to ambiguity, risk, outcomes, knowledge, action, gaps, disease modifying agents
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention applying the traffic light system (TLS)Behavioural
The TLS emerged to facilitate consumers' decisions. It has been applyied in medical decision making.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: Up to 60 min
Secondary outcomes (3)
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).
Measured: At the completion of the study, approximately 60 minutes
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.
Measured: At the completion of the study, approximately 60 minutes
Scale (physician reaction to uncertainty)
Using the 'physicians reaction to uncertainty" instrument as a continuous variable and median split.
Measured: At the completion of the study, approximately 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start22 Mar 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Gustavo Saposnik, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134794
- Sponsor's protocol ID
- REB 15-340
- Acronym
- EDUCAR MS
- Status last verified
- Oct 2020
- First submitted
- 5 Mar 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27809908Saposnik 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.
PubMed 27146451Saposnik 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.
PubMed 28203061Saposnik 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.
PubMed 28298899Saposnik 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.
PubMed 31259250Saposnik 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.
PubMed 33326024Saposnik 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.
PubMed 28871238
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making Under Uncertainty in MS Care: an Innovative Educational Intervention Applying Concepts From Neuroeconomics
- ClinicalTrials.gov ID
- NCT03134794
- Acronym / sponsor ID
- EDUCAR MS / REB 15-340
- Conditions
- Multiple Sclerosis
- Keywords
- neuroeconomics, multiple sclerosis, educational intervention, traffic light system, aversion to ambiguity, risk, outcomes, knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this study are:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: Educational intervention applying the traffic light system (TLS)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. |
| 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. |
Who may qualify
- Ages
- 23 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention applying the traffic light system (TLS)The TLS emerged to facilitate consumers' decisions. It has been applyied in medical decision making. | Behavioural | Educational Intervention |
Primary outcome
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
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.
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).
3 secondary outcomes
Efficacy of the educational intervention
Time frame: At the completion of the study, approximately 60 minutes
Scale (based on the experiment on ambiguity aversion)
Time frame: At the completion of the study, approximately 60 minutes
Scale (physician reaction to uncertainty)
Time frame: At the completion of the study, approximately 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Results publication: PubMed 27809908Saposnik 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 publication: PubMed 27146451Saposnik 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 publication: PubMed 28203061Saposnik 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 publication: PubMed 28298899Saposnik 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 publication: PubMed 31259250Saposnik 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.
- Derived from this study: PubMed 33326024Saposnik 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.
- Derived from this study: PubMed 28871238Saposnik 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.
- Decision-making in Multiple Sclerosis: The Role of Aversion to Ambiguity for Therapeutic Inertia among Neurologists (DIScUTIR MS)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Saposnik principal investigator
University of Toronto
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention applying the traffic light system (TLS) in people with Multiple Sclerosis, run by Unity Health Toronto at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina, Canada, Chile, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the educational intervention (time frame: At the completion of the study, an estimated total of 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134794, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.