Comparative Safety of Seizure Prophylaxis within the Medicare Program

医疗保险计划中癫痫预防的比较安全性

基本信息

批准号：
10277748
负责人：
Lidia Maria Veras Rocha de Moura
金额：
$ 84.17万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10277748
关键词：
Academy Acute Address Adverse effects Adverse event Advisory Committees Alzheimer&apos s Disease Alzheimer&apos s disease related dementia American American Heart Association Anticonvulsants Case Series Centers for Disease Control and Prevention (U.S.)Clinical Clinical Management Clinical Trials Communities Complex Complication Cox Proportional Hazards Models Data Data Set Detection Diagnosis Drug Labeling Drug usage Elderly Electroencephalography Electronic Health Record Emergency department visit Enrollment Epilepsy Etiology Event Family Fee-for-Service Plans Foundations Future Guidelines Hospitalization Incentives Individual Ischemic Stroke Life Link Literature Measures Medicare Medicare Part A Medicare claim Methods Modeling Names National Committee for Quality Assurance Neurology Observational Study Outcome Outpatients Patient Care Patients Pattern Pharmaceutical Preparations Physicians Policies Policy Maker Positioning Attribute Predisposition Prophylactic treatment Provider Registries Relative Risks Risk Safety Sampling Savings Scoring Method Seizures Serious Adverse Event Severities Stroke Symptoms Therapeutic Time Validation acute stroke adjudicate adverse event risk aged analytical tool base beneficiary clinical care comorbidity comparative safety cost dementia care electronic data experience fall injury falls follow-up high risk improved individualized medicine machine learning method multidisciplinary novel population based post stroke predictive modeling prevent programs randomized trial recruit safety study stroke event stroke risk stroke survivor treatment duration trial comparing

项目摘要

PI Name(s): Moura, Lidia Maria Veras Rocha de Project Title: Comparative Safety of Seizure Prophylaxis within the Medicare Program 1R01AG073410-01 Each year thousands of Medicare beneficiaries with Alzheimer’s disease and/or Alzheimer’s-related dementias (AD/ADRD) receive anticonvulsant drugs for seizure prophylaxis. These drugs are life-saving given the severity of seizure sequalae, but also life-threatening because of serious adverse events. Patients with AD/ADRD are particularly vulnerable given their high susceptibility to both stroke and adverse events. The decision to start and stop anticonvulsants also might change when the patient have AD/ADRD, in part because anticonvulsant therapy management becomes more complex when patients have difficulty with therapy having a narrow therapeutic range or difficulty recognizing early complication symptoms. There are no trial data to guide decisions about prophylaxis after an ischemic stroke among patients with or without AD/ADRD. The sparse and conflicted existing literature has been limited by the difficulty assessing relevant measures, e.g., stroke severity or AD/ADRD status, in claims. Medicare claims offer potential, but lack well-validated definitions for stroke severity, AD/ADRD status, seizures, or adverse effects. We will address these issues using a novel dataset with individual-level linked longitudinal information from registries, electronic health records, and Medicare claims, and will develop prediction models for key baseline and outcome variables. Then, using a random 20% sample of national traditional, fee-for-service Medicare claims over 18 years (2006-23), we will emulate clinical trials assessing two critical decisions in the setting of first mild to moderate ischemic stroke among patients with or without AD/ADRD: a) initiating outpatient prophylaxis versus not; and b) stopping prophylaxis at six months versus continuing. We will apply multiple analytical tools to address confounding and other challenges. We will stratify our population based on AD/ADRD status because the patterns of strokes, post-stroke seizures, and treatment complications differ among patients with compared to those without AD/ADRD, as could the clinical management patterns. We have three aims: 1) To validate claims-based prediction models for our study variables; 2) To emulate a clinical trial comparing outpatient prophylaxis initiation versus not; and 3) To emulate a clinical trial comparing stopping outpatient prophylaxis at six months versus continuing. This comparative safety study could inform future policy and clinical care and improve stroke and AD/ADRD care, e.g., through adjustments in Medicare quality incentives and clinical guidelines. Moreover, these data could help inform patients, families, clinicians, and policy makers about how we can improve care for patients who could require seizure prophylaxis.

PI名称：Moura，Lidia Maria Veras Rocha de 项目名称：Medicare计划中预防癫痫发作的比较安全性 1R01AG073410-01 每年，成千上万的Medicare受益人患有阿尔茨海默氏病和/或阿尔茨海默氏症相关的痴呆症（AD/ADRD），都会接受预防性癫痫发作的抗惊厥药物。鉴于癫痫发作的严重程度，这些药物是挽救生命的，但由于严重的不良事件而危及生命。鉴于他们对中风和不良事件的敏感性很高，AD/ADRD的患者特别容易受到伤害。当患者患有AD/ADRD时，决定开始和停止抗惊厥药的决定也可能会发生变化，部分原因是，当患者难以治疗范围狭窄或难以识别早期并发症症状时，抗惊厥治疗的管理变得更加复杂。没有试验数据可以指导有关有或没有AD/ADRD患者缺血性中风后预防的决策。在索赔中，稀疏和冲突的现有文献受到困难的评估相关措施的限制，例如中风的严重性或AD/ADRD状态。 Medicare主张具有潜力，但缺乏对中风严重性，AD/ADRD状态，癫痫发作或不良影响的验证定义。我们将使用一个新颖的数据集解决这些问题，该数据集以及来自注册表，电子健康记录和Medicare索赔的个人级别链接的纵向信息，并将为关键基线和结果变量开发预测模型。然后，使用18年（2006 - 23年）随机的20％的全国传统，费用的医疗保险索赔样本，我们将模仿临床试验，以评估有或没有AD/ADRD患者的首次轻度至中度缺血性中风的两个关键决定： b）与继续进行六个月相比，停止预防。我们将应用多种分析工具来解决混杂和其他挑战。我们将根据AD/ADRD状态对我们的人口进行分层，因为与没有AD/ADRD的患者相比，中风，冲程后癫痫发作和治疗并发症的模式不同，临床管理模式也是如此。我们有三个目标：1）验证我们的研究变量的基于索赔的预测模型； 2）模仿比较门诊预防倡议与没有的临床试验； 3）模仿临床试验，比较六个月的停止门诊预防与继续相比。这项比较安全研究可以为未来的政策和临床护理提供依据，并通过调整Medicare质量激励措施和临床准则来改善中风和AD/ADRD护理。此外，这些数据可以帮助病人，家庭，临床医生和决策者告知我们如何改善可能需要预防癫痫发作的患者的护理。