Recruiting

Observational Study

Sponsor:

Epilepsy Foundation of America

Code:

NCT06265103

Conditions

Epilepsy

Seizure Disorder

Neurologic Disorder

Rare Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Clinical care and quality improvement

Study Details

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.

Conditions

Epilepsy

Seizure Disorder

Neurologic Disorder

Rare Diseases

Study ID

NCT06265103

Start date

Mar 20, 2019

Status verified date

Aug, 2024

Completion date

Feb 14, 2099

Anticipated

Primary completion date

Feb 14, 2099

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

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.

Primary outcome measure

  • Seizure Frequency [ Time Frame: 02/2099 ]
  • Seizure Freedom [ Time Frame: 02/2099 ]
  • Quality of Life documentation [ Time Frame: 02/2099 ]
  • Screening for Barriers to Medication Adherence [ Time Frame: 02/2099 ]

Central Contacts and Locations

Central contacts

Brandy E Fureman, PhD

2404767127bfureman@efa.org

Kathleen Farrell, MB BCH BAO

732-832-5983kfarrell@efa.org

Locations

Barrow Neurological Institute Comprehensive Epilepsy Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Malinda Brooks-Busch, MPH

602-406-3443Malinda.Brooks-Busch@dignityhealth.org

Principal Investigator:

Sue Herman, MD

University of Southern California

Recruiting

Los Angeles, California, United States, 90032

Contacts

Alissa Maier, MPH

937-545-2627Alissa.Maier@med.usc.edu

Principal Investigator:

Christi Heck, MD

UC Health University of Colorado Anshutz

Recruiting

Aurora, Colorado, United States, 80045

Epilepsy Foundation

Recruiting

Bowie, Maryland, United States, 20716

Contacts

Kathleen Farrell, MB BCh BAO

732-832-5983kfarrell@efa.org

Saniya Griffin

elhs@efa.org

Principal Investigator:

Brandy Fureman, Ph.D

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

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jason Raymond Smith

617-726-3311JSMITH114@PARTNERS.ORG

Principal Investigator:

Sahar Zafar, MD

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

University of Cincinnati Gardner Neuroscience Institute Epilepsy Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Lucy Mendoza, CCRP

513-558-3020mendozlc@UCMAIL.UC.EDU

Principal Investigator:

David Ficker, MD

Penn State Hershey

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Jessica Beiler, MPH,CCRC

717-531-5656jbeiler@pennstatehealth.psu.edu

Principal Investigator:

William Trescher, MD

Children's Hospital of Philadelphia (CHOP)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nicholas Abend

abend@email.chop.edu

Principal Investigator:

Nicholas Abend, MD, MSCE

UT Southwestern Children's Dallas

Recruiting

Dallas, Texas, United States, 75063

Contacts

Bonnie Jenkins, LCSW

214-456-0614bonnie.jenkins@childrens.com

Principal Investigator:

Deepa Sirsi, MD

More Information

Sponsor

Epilepsy Foundation of America

Last update posted

Aug 30, 2024

Last verified

Aug, 2024

Keywords

  • Focal seizures
  • Generalized seizures
  • Brain conditions
  • Developmental disorders
  • Rare diseases
  • Chronic condition
  • Health disparity
  • Seizure
  • Post-traumatic epilepsy (PTE)
  • Post-stroke epilepsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Epilepsy Foundation of America on 2024-08-30.