Epilepsy Learning Healthcare System (ELHS)

Epilepsy Clinical Trial

— ELHS  

Official title:

Epilepsy Learning Healthcare System (ELHS) for Quality Care & Outcome Improvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265103
• Other study ID #: 20190407
• Status: Recruiting
• Start date: March 20, 2019
• Est. completion date: February 14, 2099

Study information

• Verified date: February 2024
• Source: Epilepsy Foundation of America
• Contact: Brandy E Fureman, PhD
• Phone: 2404767127
• Email: bfureman[@]efa.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 14, 2099
• Est. primary completion date: February 14, 2099
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Nervous System Diseases
• Neurologic Disorder
• Rare Diseases
• Seizure Disorder
• Seizures

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center's Comprehensive Epilepsy Program	Boston	Massachusetts
United States	Partners - Massachusetts General Hospital Epilepsy Service (MGH)/ Partners - Brigham and Women's (BWH)	Boston	Massachusetts
United States	Epilepsy Foundation	Bowie	Maryland
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	UT Southwestern Children's Dallas	Dallas	Texas
United States	Penn State Hershey	Hershey	Pennsylvania
United States	University of Southern California	Los Angeles	California
United States	Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute Comprehensive Epilepsy Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Epilepsy Foundation of America

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure Frequency	*Seizure frequency: A record of the exact 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
Primary	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
Primary	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