Epilepsy Learning Healthcare System (ELHS) for Quality Care & Outcome Improvement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 13
- 主要终点
- Seizure Frequency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Seizure Frequency
时间窗: 02/2099
\*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.
Seizure Freedom
时间窗: 02/2099
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.
Quality of Life documentation
时间窗: 02/2099
Percent of all visits at which a QOL assessment\* is completed by the patient. This is a visit-based process metric.
Screening for Barriers to Medication Adherence
时间窗: 02/2099
Percent of all visits at which a Barriers to Medication Adherence Tool is completed by the patient.
次要结局
未报告次要终点