Multiple Sclerosis Clinical Trial
Official title:
Decision Making in Multiple Sclerosis Care Under Uncertainty
NCT number | NCT04035720 |
Other study ID # | 15-340 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 6, 2019 |
Est. completion date | December 22, 2021 |
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.
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.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | December 22, 2021 |
Est. primary completion date | July 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 23 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Hoffmann-La Roche, University of Toronto |
Canada,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
At the completion of the study, an estimated 90 minutes | |
Primary | 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. | At the completion of the study, an estimated 90 minutes | |
Secondary | 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). | At the completion of the study, an estimated 90 minutes | |
Secondary | 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) | At the completion of the study, an estimated 90 minutes | |
Secondary | 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] |
At the completion of the study, an estimated 90 minutes |
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