Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-31 @ 6:34 PM
Study NCT ID:
NCT02670161
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-24
First Post:
2016-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Improvement and Practice Based Research in Neurology Using the EMR
Sponsor:
Endeavor Health
Organization:
Study Overview
Official Title:
Quality Improvement and Practice Based Research in Neurology Using the Electronic Medical Record
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
The goals of the proposed research are to advance quality improvement and practice based research in Neurology using the electronic medical record (EMR). The American Academy of Neurology (AAN) has published evidence-based guidelines, quality improvement measures, and resources for several neurological disorders. However, the AAN guidelines and measures have not been implemented routinely and benchmark data are lacking. There are few EMR tools available to standardize neurology office visits according to Best Practices, to provide alerts when neurological care is deviating from AAN guidelines, to capture data regarding adherence to AAN or other quality parameters, to measure the effects of compliance with guidelines on outcomes, or to share longitudinal data and to compare effectiveness of care across neurological practices. The Department of Neurology at NorthShore University HealthSystem (NorthShore) has built into its commercial EMR "Epic" structured clinical documentation support (SCDS) and clinical decision support (CDS) tools that standardize care, write progress notes, and capture up to 1,000 discrete and cascading fields of neurological data per office visit. However, these EMR tools have not been disseminated for use by other Neurology practices or for data sharing, and presently do not support clinical trials. Pragmatic trials using EMRs would enable comparisons of treatments at the point of care. To address gaps in quality improvement and practice based research in Neurology, the investigators are proposing to the Agency for Healthcare Research and Quality (AHRQ) a project with the specific aims: 1) To create a Neurology Practice Based Research Network (NPBRN). The NorthShore site will share SCDS and CDS tools for 10 common neurological disorders (brain tumors, epilepsy, migraine, mild cognitive impairment, mild traumatic brain injury, multiple sclerosis, neuropathy, Parkinson's disease, restless legs syndrome, and stroke) with seven other Department of Neurology that also use the Epic EMR platform (eight sites total). 2) To conduct at NorthShore pragmatic trials using the EMR for 10 common neurological disorders. The investigators 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. The aims are innovative because the investigators will use the EMR to hardwire quality and outcomes research in Neurology. They will individualize medicine at the point of care by conducting pragmatic trials using subgroup based adaptive designs, comparing the effectiveness of available treatments for common neurological disorders. The aims are significant because they are studying several neurological disorders, a leading cause of healthcare burden worldwide. They will create a national practice based network to improve health care quality by accelerating implementation of patient-centered outcomes research in Neurology using the EMR, and evidence to make health care safer and to improve health care efficiency. NOTE: This ClinicalTrials.gov registration relates to Aim 2 of the project (pragmatic trials using the EMR). Aim 1 is an observational study only (quality improvement, comparative effectiveness research).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HS024057-01 | AHRQ | None | https://reporter.nih.gov/quic… | View |