Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • In order to be eligible to participate in this registry-based 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

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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 Medical 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.
Mass General Hospital 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) 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.
Brigham & Women's Hospital 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 Los Angeles 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 Colorado Anshutz 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.

Recruiting Locations

Partners - Massachusetts General Hospital Epilepsy Service (MGH)/ Partners - Brigham and Women's (BWH)
Boston, Massachusetts 02114
Contact:
Jason Raymond Smith
617-726-3311
JSMITH114@PARTNERS.ORG

More Details

Status
Recruiting
Sponsor
Epilepsy Foundation of America

Study Contact

Brandy E Fureman, PhD
2404767127
bfureman@efa.org

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 2.9 Million adults and around 460,000 children. 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. Compared to the general public, people with epilepsy have higher rates of premature mortality, injury, cognitive impairment, depression, social isolation, and unemployment. In addition, there are health disparities (HD) in epilepsy that create worse health outcomes for individuals belonging to race/ethnicity minority groups or low-income households, those living in rural areas, and individuals with opposite or non-binary gender preferences. Epilepsy disparities result in worse mental health, more frequent emergency department visits, increased hospitalization rates, and increased risk of early death for these underserved groups. 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 and health outcomes. It is used successfully in a growing number of patient safety and disease-focused learning health networks. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.