Multiple SclerosisNCT04035720
Decision Making in Multiple Sclerosis Care Under Uncertainty
A study testing Quantitative risk in people with Multiple Sclerosis, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The main objectives of this study are: i) To determine patient-level, physician-level and health system factors influencing therapeutic decisions in multiple sclerosis (MS) care by applying conjoint discrete experiments. ii) To determine the prevalence of therapeutic inertia among participating neurologists. Read more about this study
- Who is it for?
- Ages 23 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Quantitative risk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2019to 22 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Actively practicing neurologist
- Expertise in treating patients with multiple sclerosis (at least 12 per year)
- Clinical setting: academic or community institutions, private practice or outpatient clinic
- Certified physicians in their specialty
- Online consent to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1X2
Gustavo Saposnik, MD, MSc, 416-864-6060, saposnikg@smh.ca
About this study
The main objectives of this study are:
- To determine patient-level, physician-level and health system factors influencing therapeutic decisions in multiple sclerosis (MS) care by applying conjoint discrete experiments. ii) To determine the prevalence of therapeutic inertia among participating neurologists. iii) To compare clinical judgement vs. a qualitative or quantitative approach when assessing for a given case-scenario. iv) To evaluate the influence of decision fatigue in treatment decisions.
Read the detailed description
The landscape of MS care is changing. Currently, there are over 15 disease modifying agents (DMTs) available to treat MS, with varying availability around the world.
Significant heterogeneity exists in the efficacy and risks associated with these therapies.
Neurologists caring for MS patients face important choices in each medical encounter: 1) continue with the same management, 2) initiate or escalate therapy for a more effective or safer agent, or 3) consider a reassessment within months under the uncertainty of the current status of the patient.
Limited information on how physicians weigh in different factors when making therapeutic decisions.
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. The physician's component is the least studied.
Therapeutic inertia (TI) is a common phenomenon in MS care defined as lack of treatment initiation or escalation (e.g. switch interferons or glatiramer to fingolimod /alemtuzumab /natalizumab/ocrelizumab/ etc.) when recommended by guidelines or evidence of disease progression. This phenomenon leads to poorer patient's outcomes, greater disability, and diminished quality of life.
Goals of the study: i) to determine what are the most relevant factors influencing therapeutic decisions among neurologists with expertise in MS care; ii) to asses whether physicians rely on medical information provided in a case scenario versus a quantitative or qualitative estimation of disease progression based on hypothetical models.
- Conditions
- Multiple Sclerosis
- Being tested
- Quantitative risk
- Keywords
- decision making, therapeutic, disease modifying agents, monoclonal antobodies, physicians, neurologists, uncertainty, neuroeconomics
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative riskOther
Participants will be able to see a square box that represent the estimated risk of disease progression. They will have to elect making a therapeutic decision based on the description of the case-scenario or based on the estimated prediction as represented in the square box.
| Study group | Role | What they receive |
|---|---|---|
| Quantitative risk estimation | Experimental | Participants will be exposed to case-scenarios. Each case scenario provides a description of the current clinical situation (e.g. patient age, current treatment, number of relapses, current EDSS, MRI findings, etc). In addition, participants will see a squared box indicating the probability of risk progression (20%, 25%, 85%, 90%). This information may or may not be accurate to reflect potential errors of risk prediction tools. Receives: Other: Quantitative risk |
| Qualitative risk estimation | Active comparator | Participants will be exposed to the same case-scenarios as the intervention arm. Each case scenario provides a description of the current clinical situation (e.g. patient age, current treatment, number of relapses, current EDSS, MRI findings, etc). In addition, participants will see a squared box indicating a qualitative probability of risk progression (low, high). This information may or may not be accurate to reflect potential errors of risk prediction tools. Receives: Other: Quantitative risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic inertia score
The therapeutic inertia (TI) score is based on our previous work published elsewhere (see references). It is based on the sum number of case-scenarios that required treatment escalation over the total number of presented scenarios (10).
Range: 0 (lowest value) to 10 (maximal value). The higher value represents the higher level of therapeutic inertia. There is no subscale. This measurement has been previously reported (Saposnik et al. JAMA Netw Open. 2019 Jul 3;2(7):e197093. doi: 10.1001/jamanetworkopen.2019.7093; Saposnik et al. MDM Policy Pract. 2019 Jun 21;4(1):2381468319855642. doi: 10.1177/2381468319855642)
Measured: At the completion of the study, an estimated 90 minutes
Accuracy of treatment decisions
Comparison of discordant pairs in each arm: Using chi-square (parametric) test, there will be a comparison between groups (intervention vs. control) in the proportion of participants who made accurate therapeutic decisions.
Measured: At the completion of the study, an estimated 90 minutes
Secondary outcomes (3)
Therapeutic decisions under fatigue
Given that participants will be exposed to several case-scenarios, a comparison of therapeutic inertia will be conducted between the first half and the second half of case scenarios as previously reported (Saposnik et al. Front Neurol. 2017 Aug 21;8:430. doi: 10.3389/fneur.2017.00430. eCollection 2017).
Measured: At the completion of the study, an estimated 90 minutes
Prevalence of therapeutic inertia (TI)
Comparison of treatment decisions using a binary definition of therapeutic inertia (TI). Lack of treatment escalation in at least one case-scenario (out of the total) will be considered as TI present as previously reported ((Saposnik et al. JAMA Netw Open. 2019 Jul 3;2(7):e197093. doi: 10.1001/jamanetworkopen.2019.7093; Saposnik et al. MDM Policy Pract. 2019 Jun 21;4(1):2381468319855642. doi: 10.1177/2381468319855642)
Measured: At the completion of the study, an estimated 90 minutes
Factors associated with therapeutic decisions
Participants will be exposed to 12 pairs of case-scenarios as per the discrete choice design. Participants have to choose the ideal case-scenario (e.g. A, B or neither- but they cannot choose both) for escalating treatment. Each pair of case-scenarios represent a comprehensive combination of possible variables. The most common factors associated with treatment escalation will be assessed based on these experimental design. A weighted estimate will be calculated for each collected variable.
See details in Discrete Choice Experiment Response Rates: A Meta-analysis.Watson V et al. Health Econ. (2017) and Saposnik et al.Stroke. 2019 Jul 22:STROKEAHA119025631. doi: 10.1161/STROKEAHA.119.025631. [Epub ahead of print]
Measured: At the completion of the study, an estimated 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start6 Jul 2019
- Primary completion21 Jul 2021 (estimated)
- Study completion22 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Gustavo Saposnik, MD, MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035720
- Sponsor's protocol ID
- 15-340
- Status last verified
- Jul 2019
- First submitted
- 25 Mar 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28298899
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making in Multiple Sclerosis Care Under Uncertainty
- ClinicalTrials.gov ID
- NCT04035720
- Acronym / sponsor ID
- 15-340
- Conditions
- Multiple Sclerosis
- Keywords
- decision making, therapeutic, disease modifying agents, monoclonal antobodies, physicians, neurologists, uncertainty, neuroeconomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, University of Toronto
- Study start
- 6 Jul 2019 (actual)
- Primary completion
- 21 Jul 2021 (estimated)
- Study completion
- 22 Dec 2021 (estimated)
- First posted
- 29 Jul 2019 (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 determine patient-level, physician-level and health system factors influencing therapeutic decisions in multiple sclerosis (MS) care by applying conjoint discrete experiments. ii) To determine the prevalence of therapeutic inertia among participating neurologists. iii) To compare clinical judgement vs. a qualitative or quantitative approach when assessing for a given case-scenario. iv) To evaluate the influence of decision fatigue in treatment decisions.
Detailed description
The landscape of MS care is changing. Currently, there are over 15 disease modifying agents (DMTs) available to treat MS, with varying availability around the world.
Significant heterogeneity exists in the efficacy and risks associated with these therapies.
Neurologists caring for MS patients face important choices in each medical encounter: 1) continue with the same management, 2) initiate or escalate therapy for a more effective or safer agent, or 3) consider a reassessment within months under the uncertainty of the current status of the patient.
Limited information on how physicians weigh in different factors when making therapeutic decisions.
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. The physician's component is the least studied.
Therapeutic inertia (TI) is a common phenomenon in MS care defined as lack of treatment initiation or escalation (e.g. switch interferons or glatiramer to fingolimod /alemtuzumab /natalizumab/ocrelizumab/ etc.) when recommended by guidelines or evidence of disease progression. This phenomenon leads to poorer patient's outcomes, greater disability, and diminished quality of life.
Goals of the study: i) to determine what are the most relevant factors influencing therapeutic decisions among neurologists with expertise in MS care; ii) to asses whether physicians rely on medical information provided in a case scenario versus a quantitative or qualitative estimation of disease progression based on hypothetical models.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quantitative risk estimation | Experimental | Other: Quantitative riskParticipants will be exposed to case-scenarios. Each case scenario provides a description of the current clinical situation (e.g. patient age, current treatment, number of relapses, current EDSS, MRI findings, etc). In addition, participants will see a squared box indicating the probability of risk progression (20%, 25%, 85%, 90%). This information may or may not be accurate to reflect potential errors of risk prediction tools. |
| Qualitative risk estimation | Active comparator | Other: Quantitative riskParticipants will be exposed to the same case-scenarios as the intervention arm. Each case scenario provides a description of the current clinical situation (e.g. patient age, current treatment, number of relapses, current EDSS, MRI findings, etc). In addition, participants will see a squared box indicating a qualitative probability of risk progression (low, high). This information may or may not be accurate to reflect potential errors of risk prediction tools. |
Who may qualify
- Ages
- 23 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Actively practicing neurologist
- Expertise in treating patients with multiple sclerosis (at least 12 per year)
- Clinical setting: academic or community institutions, private practice or outpatient clinic
- 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 |
|---|---|---|
| Quantitative riskParticipants will be able to see a square box that represent the estimated risk of disease progression. They will have to elect making a therapeutic decision based on the description of the case-scenario or based on the estimated prediction as represented in the square box. | Other | Qualitative risk estimation, Quantitative risk estimation |
Primary outcome
Therapeutic inertia score
Time frame: At the completion of the study, an estimated 90 minutes
The therapeutic inertia (TI) score is based on our previous work published elsewhere (see references). It is based on the sum number of case-scenarios that required treatment escalation over the total number of presented scenarios (10). Range: 0 (lowest value) to 10 (maximal value). The higher value represents the higher level of therapeutic inertia. There is no subscale. This measurement has been previously reported (Saposnik et al. JAMA Netw Open. 2019 Jul 3;2(7):e197093. doi: 10.1001/jamanetworkopen.2019.7093; Saposnik et al. MDM Policy Pract. 2019 Jun 21;4(1):2381468319855642. doi: 10.1177/2381468319855642)
Accuracy of treatment decisions
Time frame: At the completion of the study, an estimated 90 minutes
Comparison of discordant pairs in each arm: Using chi-square (parametric) test, there will be a comparison between groups (intervention vs. control) in the proportion of participants who made accurate therapeutic decisions.
3 secondary outcomes
Therapeutic decisions under fatigue
Time frame: At the completion of the study, an estimated 90 minutes
Prevalence of therapeutic inertia (TI)
Time frame: At the completion of the study, an estimated 90 minutes
Factors associated with therapeutic decisions
Time frame: At the completion of the study, an estimated 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- 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.
- 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, MD, MSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative risk in people with Multiple Sclerosis, run by Unity Health Toronto at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo Saposnik, MD, MSc, (4168645155, saposnikg@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic inertia score (time frame: At the completion of the study, an estimated 90 minutes). The study lists 2 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 NCT04035720, which also lists 1 linked publication.
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 29 Jul 2019.