Quality Improvement and Practice Based Research in Neurology Using the EMR

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Endeavor Health
Study ID
NCT02670161
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description) — DRUG
    brain tumors (lamotrigine, levetiracetam, valproic acid), epilepsy (lamotrigine, levetiracetam, valproic acid), mild cognitive impairment (donepezil, rivastigmine, memantine), migraine (amitriptyline, propranolol, topiramate), migraine (sumatriptan, rizatriptan, zolmitriptan), mild traumatic brain injury (omega-3 fatty acids, education only), multiple sclerosis (ACTH, methylprednisolone), neuropathy (duloxetine, pregabalin, amitryptiline), Parkinson's disease (pramipexole, ropinerole, rotigotine), restless legs syndrome (pramipexole, ropinerole, rotigotine), stroke (aspirin, clopidogrel).

Study Details

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.

Key Dates

Start date
May 31, 2016
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
3,300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment A (see interventions description)
    The investigators will conduct 11 pragmatic trials using the EMR: brain tumors (prevent seizures), epilepsy (prevent other seizure types), mild cognitive impairment (improve memory), migraine (prevention), migraine (abortive), mild traumatic brain injury (prevent post concussion syndrome), multiple sclerosis (attenuate relapses), neuropathy (pain management), Parkinson's (treat motor symptoms), restless legs syndrome (treat sensory symptoms), stroke (secondary prevention). For each trial they will compare up to three medications or treatments either FDA approved for the indication, or commonly employed. The pragmatic trials will be small and primarily to demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and data capture at the point of care using the EMR. The focus is on the development of the study design and methodology and not on the treatments per se.
  • Active Comparator: Treatment B (see interventions description)
    The investigators will conduct 11 pragmatic trials using the EMR: brain tumors (prevent seizures), epilepsy (prevent other seizure types), mild cognitive impairment (improve memory), migraine (prevention), migraine (abortive), mild traumatic brain injury (prevent post concussion syndrome), multiple sclerosis (attenuate relapses), neuropathy (pain management), Parkinson's (treat motor symptoms), restless legs syndrome (treat sensory symptoms), stroke (secondary prevention). For each trial they will compare up to three medications or treatments either FDA approved for the indication, or commonly employed. The pragmatic trials will be small and primarily to demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and data capture at the point of care using the EMR. The focus is on the development of the study design and methodology and not on the treatments per se.
  • Active Comparator: Treatment C (see interventions description)
    The investigators will conduct 11 pragmatic trials using the EMR: brain tumors (prevent seizures), epilepsy (prevent other seizure types), mild cognitive impairment (improve memory), migraine (prevention), migraine (abortive), mild traumatic brain injury (prevent post concussion syndrome), multiple sclerosis (attenuate relapses), neuropathy (pain management), Parkinson's (treat motor symptoms), restless legs syndrome (treat sensory symptoms), stroke (secondary prevention). For each trial they will compare up to three medications or treatments either FDA approved for the indication, or commonly employed. The pragmatic trials will be small and primarily to demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and data capture at the point of care using the EMR. The focus is on the development of the study design and methodology and not on the treatments per se.

Primary Outcome Measure

survival free of discontinuation or alternative prevention drug (migraine trial) [ Time Frame: six months ]

Locations (1)

FacilityCityStateZIPSite coordinators
NorthShore University HealthSystemEvanstonIllinois60201-

Find similar trials in Evanston, IL

By condition
EpilepsyMigraineMultiple sclerosisParkinson's diseaseStroke
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
NorthShore University HealthSystem· Evanston, IL

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