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Epilepsy Learning Healthcare System (ELHS)

Recruiting
Conditions
Neurologic Disorder
Epilepsy
Rare Diseases
Seizure Disorder
Interventions
Other: Clinical care and quality improvement
Registration Number
NCT06265103
Lead Sponsor
Epilepsy Foundation of America
Brief Summary

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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Barrow Neurological Institute Comprehensive Epilepsy CenterClinical care and quality improvementCenters 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.
Cincinnati Children's Hospital Medical CenterClinical care and quality improvementCenters 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.
Children's Hospital of Philadelphia (CHOP)Clinical care and quality improvementCenters 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.
Children's Hospital of Orange County (CHOC)Clinical care and quality improvementCenters 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.
Mass General HospitalClinical care and quality improvementCenters 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.
Penn State HersheyClinical care and quality improvementCenters 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.
University of Cincinnati Gardner Neuroscience InstituteClinical care and quality improvementCenters 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.
University of Southern California (USC)Clinical care and quality improvementCenters 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.
UT Southwestern Children's DallasClinical care and quality improvementCenters 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.
Brigham & Women's HospitalClinical care and quality improvementCenters 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.
Children's Hospital Los AngelesClinical care and quality improvementCenters 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.
University of Colorado AnshutzClinical care and quality improvementCenters 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.
Primary Outcome Measures
NameTimeMethod
Seizure Frequency02/2099

\*Seizure frequency: A record of the 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.

Seizure Freedom02/2099

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.

Quality of Life documentation02/2099

Percent of all visits at which a QOL assessment\* is completed by the patient. This is a visit-based process metric.

Screening for Barriers to Medication Adherence02/2099

Percent of all visits at which a Barriers to Medication Adherence Tool is completed by the patient.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (13)

Children's Hospital Los Angeles

🇺🇸

Los Angeles, California, United States

Brigham & Women's Hospital

🇺🇸

Boston, Massachusetts, United States

University of Southern California

🇺🇸

Los Angeles, California, United States

Partners - Massachusetts General Hospital Epilepsy Service (MGH)/ Partners - Brigham and Women's (BWH)

🇺🇸

Boston, Massachusetts, United States

Cincinnati Children's Hospital Comprehensive Epilepsy Center (CCHMC)

🇺🇸

Cincinnati, Ohio, United States

University of Cincinnati Gardner Neuroscience Institute Epilepsy Center

🇺🇸

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia (CHOP)

🇺🇸

Philadelphia, Pennsylvania, United States

UT Southwestern Children's Dallas

🇺🇸

Dallas, Texas, United States

UC Health University of Colorado Anshutz

🇺🇸

Aurora, Colorado, United States

Akron Children's Hospital

🇺🇸

Akron, Ohio, United States

Barrow Neurological Institute Comprehensive Epilepsy Center

🇺🇸

Phoenix, Arizona, United States

Epilepsy Foundation

🇺🇸

Bowie, Maryland, United States

Penn State Hershey

🇺🇸

Hershey, Pennsylvania, United States

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