Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT04035720

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 23 - 70+

Healthy Volunteers: Not accepted

Interventions

Quantitative risk

Study Details

Brief 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.

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.

Conditions

Multiple Sclerosis

Study ID

NCT04035720

Start date

Jul 6, 2019

Status verified date

Jul, 2019

Completion date

Dec 22, 2021

Anticipated

Primary completion date

Jul 21, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 23 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Quantitative risk estimation

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.

active comparator: Qualitative risk estimation

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.

Interventions

Quantitative risk

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.

Primary outcome measure

  • Therapeutic inertia score [ Time Frame: At the completion of the study, an estimated 90 minutes ]
  • Accuracy of treatment decisions [ Time Frame: At the completion of the study, an estimated 90 minutes ]

Central Contacts and Locations

Central contacts

Gustavo Saposnik, MD, MSc,

4168645155saposnikg@smh.ca

Roula Raptis, Msc

416-864-6060RaptisS@smh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1X2

Contacts

Gustavo Saposnik, MD, MSc

416-864-6060saposnikg@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Jul 29, 2019

Last verified

Jul, 2019

Keywords

  • decision making
  • therapeutic
  • disease modifying agents
  • monoclonal antobodies
  • physicians
  • neurologists
  • uncertainty
  • neuroeconomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-07-29.