A Decision Support Tool for the Discontinuation of Disease Modifying Therapies in Multiple Sclerosis
A point-of-care decision support tool for discontinuing disease-modifying therapies in those with multiple sclerosis has the potential to reduce the risk incurred and the financial burden of those patients using these medications.
Project Details -
Ongoing
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Grant NumberR21 HS029219
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AHRQ Funded Amount$991,428
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Principal Investigator(s)
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Organization
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LocationClevelandOhio
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Project Dates08/01/2023 - 07/31/2028
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Care Setting
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Medical Condition
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Type of Care
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Health Care Theme
The treatment of multiple sclerosis (MS) was transformed by disease-modifying therapies (DMTs), particularly for those early in the course of their disease. These medications prevent the accumulation of lesions, relapses, and disability. However, they are expensive and have infection risks, ranging from simple urinary tract infections to ones that lead to hospitalization and even death. Observational research has shown that older patients who have been on DMTs for several years without relapses or new lesions have a low risk of new lesions or inflammatory disease activity if these medications are discontinued. Despite the growing evidence to support DMT discontinuation in some individuals, there is a lack of consensus from neurological societies and no standardized approach for making this recommendation.
This research will develop, validate, and evaluate a point-of-care decision support tool using a machine learning (ML) algorithm to standardize the approach to recommend MS DMT discontinuation. The tool will provide a risk assessment and a standardized approach clinicians can use to guide their discussions with patients around discontinuing their medications.
The specific aims of the research are as follows:
- Develop and validate a point-of-care clinical decision support tool for discontinuation of DMTs for people with MS.
- Implement the clinical decision support tool into clinical workflow and evaluate clinical outcomes.
The researchers will develop the ML algorithm using retrospective data from the Cleveland Clinic’s Mellen Center for Multiple Sclerosis. The algorithm will then be validated using the database from a clinical trial the researchers participated in: “Discontinuation of disease-modifying therapies in multiple sclerosis.” This trial was the first MS treatment discontinuation trial, and the largest trial ever for older patients with MS. The validated tool will then be implemented in a large electronic health record system and evaluated with a clinical trial to assess adoption and impact on outcomes over 2 years. The tool will provide an individualized risk assessment if a DMT is discontinued, evidence on the annual risk of infection due to the DMT, and the annual cost of the DMT. Exposing clinicians to the tool will allow for shared decision making between patients and their providers.
This research has the potential to provide guidance on when to recommend MS DMT discontinuation, reducing the risk incurred and financial burden of those medications.