Decision Making in Multiple Sclerosis Care Under Uncertainty

NCT04035720 | Unknown

• 1 other identifier: 15-340
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Therapeutic decisions under fatigue

  At the completion of the study, an estimated 90 minutes

• Prevalence of therapeutic inertia (TI)

  At the completion of the study, an estimated 90 minutes

• Factors associated with therapeutic decisions

  At the completion of the study, an estimated 90 minutes

Study Arms (2)

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.

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.

Other: Quantitative risk

Interventions

Quantitative risk OTHER

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.

Qualitative risk estimation; Quantitative risk estimation

Eligibility Criteria

• Age: 23 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Hoffmann-La Roche: collaborator
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1X2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 28298899 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gustavo Saposnik, MD, MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Saposnik, MD, MSc,

CONTACT

4168645155; saposnikg@smh.ca

Roula Raptis, Msc

CONTACT

416-864-6060; RaptisS@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: July 29, 2019
• Study Start: July 6, 2019
• Primary Completion: July 21, 2021
• Study Completion: December 22, 2021
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)