EMR-Based Treatment for Neurological Disorders

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NorthShore University HealthSystem

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by disorder

3300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is EMR-based treatment for neurological disorders generally safe for humans?

The research on EMR-based treatment for neurological disorders does not provide specific safety data, but it involves quality improvement and practice-based research, which are generally considered safe approaches in healthcare. ^{1 2 3 4 5}

How does the EMR-based treatment for neurological disorders differ from other treatments?

The EMR-based treatment for neurological disorders is unique because it uses electronic medical records to standardize patient data collection and support practice-based research, which helps improve the quality of care and tailor treatments to individual needs. This approach allows for more precise tracking of patient progress and facilitates the sharing of data across departments to enhance research and treatment strategies. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment for neurological disorders using EMR-based quality improvement and practice-based research?

The use of electronic medical records (EMRs) in neurology helps standardize patient data collection and supports quality improvement and research, which can lead to better care for conditions like memory disorders and epilepsy. By using structured documentation and decision support tools, EMRs can improve the management and outcomes of various neurological disorders. ^{2 6 7 8 10}

Are You a Good Fit for This Trial?

This trial is for individuals with neurological conditions like brain tumors, epilepsy, migraine, cognitive impairments due to mild injury or concussion, multiple sclerosis (MS), neuropathy, Parkinson's disease, restless legs syndrome and stroke. Participants must be eligible for the treatments being tested as per FDA approval or standard off-label use.

Inclusion Criteria

I have been diagnosed with a neurological condition such as MS, Parkinson's, epilepsy, or had a stroke.

I am eligible for treatments approved or used off-label by the FDA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subgroup based adaptive assignment of treatments for neurological disorders using the EMR

Varies by disorder

Follow-up

Participants are monitored for safety and effectiveness after treatment using outcomes data capture at the point of care

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quality Improvement and Practice Based Research

Trial Overview The study at NorthShore University HealthSystem is testing up to three drugs for each of ten common neurological disorders using electronic medical records (EMR). It aims to find the most effective treatments through adaptive assignment and capture outcomes data directly during patient care.

How Is the Trial Designed?

Group I: Treatment B (see interventions description) Active Control 1 Intervention

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.

Group II: Treatment A (see interventions description) Active Control 1 Intervention

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.

Group III: Treatment C (see interventions description) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Published Research Related to This Trial

In a study of 150 stroke patients, 170 adverse events (AEs) and no-harm incidents were identified, affecting over half of the patients, highlighting the high incidence of patient harm in stroke care.

The most common AEs included ischemic strokes and urinary tract infections, with a significant portion of medication events being preventable, indicating a need for improved safety measures in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. Nowak, B., Schwendimann, R., Lyrer, P., et al.[2022]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

A prospective patient registry for neurosurgical procedures, implemented in 2013, successfully captured data from 8226 patients across nearly 12,000 surgeries, highlighting its effectiveness in tracking complications over time.

The Clavien-Dindo grade (CDG) was validated as a reliable method for classifying complications, showing a clear correlation with patient outcomes such as performance status and length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. Sarnthein, J., Staartjes, VE., Regli, L.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Quality improvement and practice-based research in neurology using the electronic medical record. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Building of EMR Tools to Support Quality and Research in a Memory Disorders Clinic. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Patients' needs assessment documentation in multidisciplinary electronic health records. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Special requirements for electronic medical records in neurology. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Structured clinical documentation in the electronic medical record to improve quality and to support practice-based research in epilepsy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The neurologist and patient safety. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

An exploratory study of the electronic medical record and outpatient vascular neurology consultations. [2018]