NCT06265103

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
886mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2019Feb 2099

Study Start

First participant enrolled

March 20, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
75 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2099

Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

80 years

First QC Date

May 28, 2020

Last Update Submit

August 28, 2024

Conditions

Keywords

Focal seizuresGeneralized seizuresBrain conditionsDevelopmental disordersRare diseasesChronic conditionHealth disparitySeizurePost-traumatic epilepsy (PTE)Post-stroke epilepsy

Outcome Measures

Primary Outcomes (4)

  • 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.

    02/2099

  • 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.

    02/2099

  • 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.

    02/2099

  • Screening for Barriers to Medication Adherence

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

    02/2099

Study Arms (12)

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

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

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

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

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

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

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

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

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

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

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

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

Interventions

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.

Barrow Neurological Institute Comprehensive Epilepsy CenterBrigham & Women's HospitalChildren's Hospital Los AngelesChildren's Hospital of Orange County (CHOC)Children's Hospital of Philadelphia (CHOP)Cincinnati Children's Hospital Medical CenterMass General HospitalPenn State HersheyUT Southwestern Children's DallasUniversity of Cincinnati Gardner Neuroscience InstituteUniversity of Colorado AnshutzUniversity of Southern California (USC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Barrow Neurological Institute Comprehensive Epilepsy Center

Phoenix, Arizona, 85013, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

NOT YET RECRUITING

University of Southern California

Los Angeles, California, 90032, United States

RECRUITING

UC Health University of Colorado Anshutz

Aurora, Colorado, 80045, United States

RECRUITING

Epilepsy Foundation

Bowie, Maryland, 20716, United States

RECRUITING

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

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Akron Children's Hospital

Akron, Ohio, 44308, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Comprehensive Epilepsy Center (CCHMC)

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

University of Cincinnati Gardner Neuroscience Institute Epilepsy Center

Cincinnati, Ohio, 45267, United States

RECRUITING

Penn State Hershey

Hershey, Pennsylvania, 17033, United States

RECRUITING

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

UT Southwestern Children's Dallas

Dallas, Texas, 75063, United States

RECRUITING

Related Publications (16)

  • Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.

    PMID: 24730690BACKGROUND
  • Zack MM, Kobau R. National and State Estimates of the Numbers of Adults and Children with Active Epilepsy - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Aug 11;66(31):821-825. doi: 10.15585/mmwr.mm6631a1.

    PMID: 28796763BACKGROUND
  • Institute of Medicine (US) Committee on the Public Health Dimensions of the Epilepsies; England MJ, Liverman CT, Schultz AM, Strawbridge LM, editors. Epilepsy Across the Spectrum: Promoting Health and Understanding. Washington (DC): National Academies Press (US); 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK91506/

    PMID: 22993876BACKGROUND
  • Thurman DJ, Logroscino G, Beghi E, Hauser WA, Hesdorffer DC, Newton CR, Scorza FA, Sander JW, Tomson T; Epidemiology Commission of the International League Against Epilepsy. The burden of premature mortality of epilepsy in high-income countries: A systematic review from the Mortality Task Force of the International League Against Epilepsy. Epilepsia. 2017 Jan;58(1):17-26. doi: 10.1111/epi.13604. Epub 2016 Nov 26.

    PMID: 27888514BACKGROUND
  • Wasade VS, Spanaki M, Iyengar R, Barkley GL, Schultz L. AAN Epilepsy Quality Measures in clinical practice: a survey of neurologists. Epilepsy Behav. 2012 Aug;24(4):468-73. doi: 10.1016/j.yebeh.2012.05.017. Epub 2012 Jul 5.

    PMID: 22770880BACKGROUND
  • Sanchez Fernandez I, Abend NS, Agadi S, An S, Arya R, Brenton JN, Carpenter JL, Chapman KE, Gaillard WD, Glauser TA, Goodkin HP, Kapur K, Mikati MA, Peariso K, Ream M, Riviello J Jr, Tasker RC, Loddenkemper T; Pediatric Status Epilepticus Research Group (pSERG). Time from convulsive status epilepticus onset to anticonvulsant administration in children. Neurology. 2015 Jun 9;84(23):2304-11. doi: 10.1212/WNL.0000000000001673. Epub 2015 May 6.

    PMID: 25948729BACKGROUND
  • Mytinger JR, Joshi S; Pediatric Epilepsy Research Consortium, Section on Infantile Spasms. The current evaluation and treatment of infantile spasms among members of the Child Neurology Society. J Child Neurol. 2012 Oct;27(10):1289-94. doi: 10.1177/0883073812455692. Epub 2012 Aug 21.

    PMID: 22914371BACKGROUND
  • Cui W, Kobau R, Zack MM; US Centers for Disease Control and Prevention, Epilepsy Program. Among adults with epilepsy reporting recent seizures, one of four on antiseizure medication and three of four not on medication had not seen a neurologist/epilepsy specialist within the last year, the 2010 and 2013 US National Health Interview Surveys. Epilepsy Behav. 2016 Aug;61:78-79. doi: 10.1016/j.yebeh.2016.04.031. Epub 2016 Jun 17.

    PMID: 27318431BACKGROUND
  • Burneo JG, Jette N, Theodore W, Begley C, Parko K, Thurman DJ, Wiebe S; Task Force on Disparities in Epilepsy Care; North American Commission of the International League Against Epilepsy. Disparities in epilepsy: report of a systematic review by the North American Commission of the International League Against Epilepsy. Epilepsia. 2009 Oct;50(10):2285-95. doi: 10.1111/j.1528-1167.2009.02282.x. Epub 2009 Sep 3.

    PMID: 19732134BACKGROUND
  • Faught E, Richman J, Martin R, Funkhouser E, Foushee R, Kratt P, Kim Y, Clements K, Cohen N, Adoboe D, Knowlton R, Pisu M. Incidence and prevalence of epilepsy among older U.S. Medicare beneficiaries. Neurology. 2012 Feb 14;78(7):448-53. doi: 10.1212/WNL.0b013e3182477edc. Epub 2012 Jan 18.

    PMID: 22262750BACKGROUND
  • Avetisyan R, Cabral H, Montouris G, Jarrett K, Shapiro GD, Berlowitz DR, Kase CS, Kazis LE. Evaluating racial/ethnic variations in outpatient epilepsy care. Epilepsy Behav. 2013 Apr;27(1):95-101. doi: 10.1016/j.yebeh.2012.12.020. Epub 2013 Feb 9.

    PMID: 23399943BACKGROUND
  • Jette N, Quan H, Faris P, Dean S, Li B, Fong A, Wiebe S. Health resource use in epilepsy: Significant disparities by age, gender, and aboriginal status. Epilepsia. 2008 Apr;49(4):586-93. doi: 10.1111/j.1528-1167.2007.01466.x. Epub 2007 Dec 28.

    PMID: 18177361BACKGROUND
  • Schiltz NK, Koroukian SM, Singer ME, Love TE, Kaiboriboon K. Disparities in access to specialized epilepsy care. Epilepsy Res. 2013 Nov;107(1-2):172-80. doi: 10.1016/j.eplepsyres.2013.08.003. Epub 2013 Aug 16.

    PMID: 24008077BACKGROUND
  • Sim Y, Nokes B, Byreddy S, Chong J, Coull BM, Labiner DM. Healthcare utilization of patients with epilepsy in Yuma County, Arizona: do disparities exist? Epilepsy Behav. 2014 Feb;31:307-11. doi: 10.1016/j.yebeh.2013.10.018. Epub 2013 Nov 5.

    PMID: 24210458BACKGROUND
  • Institute of Medicine (US) Roundtable on Evidence-Based Medicine; Olsen L, Aisner D, McGinnis JM, editors. The Learning Healthcare System: Workshop Summary. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK53494/

    PMID: 21452449BACKGROUND
  • Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.

    PMID: 17679641BACKGROUND

MeSH Terms

Conditions

EpilepsyNervous System DiseasesRare DiseasesSeizuresBrain DiseasesDevelopmental DisabilitiesChronic DiseaseEpilepsy, Post-Traumatic

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsNeurodevelopmental DisordersMental DisordersBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services Administration

Study Officials

  • Brandy Fureman, PhD

    Epilepsy Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandy E Fureman, PhD

CONTACT

Kathleen Farrell, MB BCH BAO

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

February 20, 2024

Study Start

March 20, 2019

Primary Completion (Estimated)

February 14, 2099

Study Completion (Estimated)

February 14, 2099

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR
Time Frame
No time frame.
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.

Locations