Stroke Clinical Trial
Official title:
Quality Improvement and Practice Based Research in Neurology Using the Electronic Medical Record
Verified date | September 2023 |
Source | NorthShore University HealthSystem |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will conduct at NorthShore University HealthSystem pragmatic trials using the EMR for 10 common neurological disorders. They will demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data capture at the point of care using the EMR. They will identify the most effective treatments for common neurological disorders and seek replication by the NPBRN.
Status | Enrolling by invitation |
Enrollment | 3300 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Diagnosis of brain tumors, epilepsy, migraine, mild cognitive impairment (concussion), mild traumatic brain injury, multiple sclerosis, neuropathy, Parkinson's disease, restless legs syndrome, and stroke. - Eligible to receive any of the three compared treatments according to FDA approval for the indication or off label use according to standard of care. Exclusion Criteria: -- None |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
NorthShore University HealthSystem |
Maraganore DM, Frigerio R, Kazmi N, Meyers SL, Sefa M, Walters SA, Silverstein JC. Quality improvement and practice-based research in neurology using the electronic medical record. Neurol Clin Pract. 2015 Oct;5(5):419-429. doi: 10.1212/CPJ.0000000000000176. — View Citation
Narayanan J, Dobrin S, Choi J, Rubin S, Pham A, Patel V, Frigerio R, Maurer D, Gupta P, Link L, Walters S, Wang C, Ji Y, Maraganore DM. Structured clinical documentation in the electronic medical record to improve quality and to support practice-based research in epilepsy. Epilepsia. 2017 Jan;58(1):68-76. doi: 10.1111/epi.13607. Epub 2016 Nov 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | survival free of discontinuation or alternative prevention drug (migraine trial) | six months | ||
Primary | survival free of disability measured by FAQ score 9+ (memory trial) | one year | ||
Primary | survival free of discontinuation or alternative anti epileptic drug (epilepsy trial) | one year |
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