Epilepsy Learning Healthcare System (ELHS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEpilepsy Foundation of America
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is in an established care relationship with the ELHS site
Disqualifiers
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.
Trial population
People of all ages diagnosed with epilepsy by a physician and in an established care relationship, and their families and caregivers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical care and quality improvement
Other interventionAll 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.
Treatment groups
100,000 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: Barrow Neurological Institute Comprehensive Epilepsy Center1 intervention
Group B: Cincinnati Children's Hospital Medical Center1 intervention
Group C: Children's Hospital of Philadelphia (CHOP)1 intervention
Group D: Children's Hospital of Orange County (CHOC)1 intervention
Group E: Mass General Hospital1 intervention
Group F: Penn State Hershey1 intervention
Group G: University of Cincinnati Gardner Neuroscience Institute1 intervention
Group H: University of Southern California (USC)1 intervention
Group I: UT Southwestern Children's Dallas1 intervention
Group J: Brigham & Women's Hospital1 intervention
Group K: Children's Hospital Los Angeles1 intervention
Group L: University of Colorado Anshutz1 intervention
Trial outcomes
Primary outcomes
1
Seizure Frequency
\*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.
Time frame
02/20992
Seizure Freedom
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.
Time frame
02/20993
Quality of Life documentation
Percent of all visits at which a QOL assessment\* is completed by the patient. This is a visit-based process metric.
Time frame
02/20994
Screening for Barriers to Medication Adherence
Percent of all visits at which a Barriers to Medication Adherence Tool is completed by the patient.
Time frame
02/2099Sponsors and contacts
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Source ClinicalTrials.gov