Epilepsy Learning Healthcare System (ELHS) (ELHS)

February 15, 2024 updated by: Epilepsy Foundation of America

Epilepsy Learning Healthcare System (ELHS) for Quality Care & Outcome Improvement

The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding".

The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Epilepsy Learning Healthcare System (ELHS; pronounced el-is) involves patients and families living with epilepsy, clinicians who provide epilepsy care (including pediatric and adult epileptologists, neurology nurses, and others), community services providers, as well as researchers with clinical research expertise in community-based, observational, interventional, implementation and dissemination studies. Each stakeholder agrees to work together to improve outcomes for people with epilepsy.

NETWORK AIM The purpose of the network is to improve seizure control and quality of life for people with epilepsy through a learning healthcare system, in which clinical data are collected, analyzed, and rapidly disseminated to change practice.

BACKGROUND Epilepsy is a chronic neurological disorder characterized by unprovoked seizures. Epidemiological data indicate that 10% of Americans will suffer at least one seizure at some point in their lives, and 1-2% of Americans have epilepsy. Active epilepsy affects 3.4 million Americans - currently estimated at 2,865,000 adults and . At least 50% of the total population of individuals with epilepsy will have started having seizures at less than 20 years of age. More than half of U.S. adults with active epilepsy have high school diploma/GED or less education. There are racial, ethnic, socioeconomic, and geographic disparities in access to comprehensive epilepsy care and significant inequities in health outcomes.

Compared to the general public, people with epilepsy have higher rates of premature mortality, injury, cognitive impairment, depression, social isolation, and unemployment. Epilepsy is not a single disease. Rather, it is a heterogeneous set of disorders with genetic and acquired etiologies. The diversity of seizure types, epilepsy syndromes, outcomes and etiologies, cannot be overstated. It is likely that the extreme heterogeneity of the epilepsies is at least partially responsible for slow progress towards meaningful treatment strategies to improve outcomes. For some, epilepsy is a manageable chronic illness -- affected individuals have risen to the highest echelons of professional success. However, for others, epilepsy is a devastating and progressive disease leading to cognitive regression and early death. Wide variations in epilepsy care delivery and clinical practice may also contribute to poor individual outcomes.

The ELHS community will work towards its mission of improving outcomes for children and adults with Epilepsy by setting up a platform to support continuous and sustained improvement activities.

The ELHS network uses the Institute for Healthcare Improvement's "Model for Improvement", focusing on the three questions - What are we trying to accomplish? How will we know that a change is an improvement? What change can we make that will result in improvement? Iterative Plan- Do-Study-Act (PDSA) learning cycles are used to test and implement changes. The Model for Improvement is widely accepted across healthcare systems as a method to improve quality.

With guidance from experts in QI and care delivery, participating programs collect and share data, test specific changes in care, and determine how to redesign and incorporate improvements into daily practice. Most measures are reported monthly and shared transparently across the ELHS Network to generate discussion and drive QI efforts. Network-wide data are reviewed monthly on Action Period calls to learn from the variation amongst programs and to recognize and celebrate network-wide improvements.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kathleen Farrell, MB BCh BAO
  • Phone Number: 732-832-5983
  • Email: kfarrell@efa.org

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute Comprehensive Epilepsy Center
        • Contact:
        • Principal Investigator:
          • Sue Herman, MD
    • California
      • Los Angeles, California, United States, 90032
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Christi Heck, MD
    • Maryland
      • Bowie, Maryland, United States, 20716
        • Recruiting
        • Epilepsy Foundation
        • Contact:
          • Kathleen Farrell, MB BCh BAO
          • Phone Number: 732-832-5983
          • Email: kfarrell@efa.org
        • Contact:
        • Principal Investigator:
          • Brandy Fureman, Ph.D
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Partners - Massachusetts General Hospital Epilepsy Service (MGH)/ Partners - Brigham and Women's (BWH)
        • Contact:
        • Principal Investigator:
          • Daniel Hoch, MD, Ph.D
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center's Comprehensive Epilepsy Program
        • Contact:
        • Principal Investigator:
          • Bernard Chang, M.D., M.M.Sc.
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Not yet recruiting
        • Cincinnati Children's Hospital Comprehensive Epilepsy Center (CCHMC)
        • Contact:
        • Principal Investigator:
          • Katie Holland
      • Cincinnati, Ohio, United States, 45267
        • Not yet recruiting
        • University of Cincinnati Gardner Neuroscience Institute Epilepsy Center
        • Contact:
        • Principal Investigator:
          • David Ficker, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Not yet recruiting
        • Penn State Hershey
        • Contact:
        • Principal Investigator:
          • William Trescher, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Children's Hospital of Philadelphia (CHOP)
        • Principal Investigator:
          • Nicholas Abend, MD, MSCE
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75063
        • Recruiting
        • UT Southwestern Children's Dallas
        • Contact:
        • Principal Investigator:
          • Deepa Sirsi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

People of all ages diagnosed with epilepsy by a physician and in an established care relationship, and their families and caregivers.

Description

Inclusion Criteria:

  • In order to be eligible to participate in this registry-based research study, an individual must meet all of the following criteria:

    • Patient is in an established care relationship with the ELHS site

Exclusion Criteria:

  • An individual who meets any of the following criteria will be excluded from participation in this registry-based research study:

    • Patients who are not currently in nor expect to be in an established care relationship with the ELHS site (for example, patients who are being seen at the center for a second opinion only).
    • Patients who do not, after diagnostic evaluation, meet criteria for a diagnosis of epilepsy will not be analyzed in epilepsy-specific population groups. However, these non-epilepsy patients will not be excluded from the registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Barrow Neurological Institute Comprehensive Epilepsy Center
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
Cincinnati Children's Hospital Comprehensive Epilepsy Center
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
Children's Hospital of Philadelphia (CHOP)
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
Children's Hospital of Orange County (CHOC)
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
Partners - MGH/BWH
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
Penn State Hershey
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
University of Cincinnati Gardner Neuroscience Institute
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
University of Southern California (USC)/(CHLA)
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.
UT Southwestern Children's Dallas
Centers participating in ELHS will work towards accomplishing the improved process and clinical outcomes by implementing changes via Quality Improvement methodology in the context of a Chronic Care model. Specifically, programs will introduce common data elements and standardized epilepsy care metrics followed by rapid cycle feedback via site specific and overall network outcomes. Interventions will then be introduced based upon evidence-based recommendations to improve outcomes. Network-based changes to practice such as those suggested have never been realized in the domain of epilepsy to date.
Other: Clinical care and quality improvement
All eligible patients at each center will be included in the registry for clinical care, quality improvement and other activities that do not meet the regulatory requirements of human subjects research. Use of data for these purposes is not considered to be a human subjects research activity and will be covered under a Business Associates Agreement and a Participation and Data Use Agreement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Frequency
Time Frame: 02/2099
*Seizure frequency: A record of the exact number of seizures gathered from patient records, journal, or calendar OR the average or typical recent seizure frequency, often expressed as the average daily, weekly, or monthly seizure frequency since the last visit.
02/2099
Seizure Freedom
Time Frame: 02/2099
Percent of all patients with visits within the time interval who have had no seizures in the last 12 months. This is a population outcome metric.
02/2099
Quality of Life documentation
Time Frame: 02/2099
Percent of all visits at which a QOL assessment* is completed by the patient. This is a visit-based process metric.
02/2099

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epilepsy Foundation of America

Investigators

  • Principal Investigator: Brandy Fureman, PhD, Epilepsy Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Estimated)

February 14, 2099

Study Completion (Estimated)

February 14, 2099

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To expand the possibilities for conducting outcomes research beyond the network investigators, data will be shared, following appropriate IRB review and approval prior to releasing data, with qualified investigators external to the network who are employed at, or affiliated with, institutions that are interested in conducting health services or comparative effectiveness research.

Non-aggregate data must be maintained on an organization's secure servers and not downloaded to peripheral devices, including laptops, USB drives or workstations. Any individual or organization receiving the data must respect the limitations of the agreement including requirements on custody of data being maintained on organization servers.

IPD Sharing Time Frame

No time frame.

IPD Sharing Access Criteria

External investigators and ELHS Participants may use shared data only under the terms of the agreement regardless of de-identification status. De-identification does not release data from terms of the agreement.

Non-aggregate data must be maintained on an organization's secure servers and not downloaded to peripheral devices, including laptops, USB drives or workstations. Any individual or organization receiving the data must respect the limitations of the agreement including requirements on custody of data being maintained on organization servers.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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