Decision Making in Multiple Sclerosis Care Under Uncertainty

NCT ID: NCT04035720

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-06
• Study Completion Date: 2021-12-22

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Quantitative risk

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Quantitative risk

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo Saposnik, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Gustavo Saposnik, MD, MSc,

Role: CONTACT

saposnikg@smh.ca

4168645155

Roula Raptis, Msc

Role: CONTACT

RaptisS@smh.ca

416-864-6060 ext. 7106

Facility Contacts

Gustavo Saposnik, MD, MSc

Role: primary

saposnikg@smh.ca

416-864-6060

References

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.

Reference Type: RESULT

PMID: 28298899 (View on PubMed)

Other Identifiers

15-340

Identifier Type: -

Identifier Source: org_study_id