Current Antipsychotics and Fractures in Nursing Homes

目前疗养院的抗精神病药物和骨折

基本信息

批准号：
7036304
负责人：
SALLY K RIGLER
金额：
$ 31.24万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-04-03 至 2009-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7036304
关键词：
accident proneness accidental falls antipsychotic agents bone fracture clinical research dosage drug adverse effect epidemiology haloperidol hip fractures human data injury mathematical model nursing homes risperidone serotonin inhibitor

项目摘要

DESCRIPTION (provided by applicant): Background: Fall-related fractures are associated with mortality, morbidity, functional decline, and reduced quality of life in nursing home (NH) residents. Antipsychotic (AP) drugs are used in 25% of NH residents to treat dementia-related behavioral & psychological symptoms. AP drug use is known to be associated with falls and fractures, but these findings are derived from studies using older, typical APs. Newer, atypical APs are reported to have better tolerability and fewer extrapyramidal side effects than older, typical APs. Due to rapid adoption of newer, atypical APs in NH settings, fracture patterns during AP use must be re-examined. Large observational data sets can be used to examine events such as fracture that may be relatively rare in short-term clinical trials. Study Aims: 1) to determine whether fracture rates (hip- and non-hip fracture) are higher among incident APUsers than Non-Users; 2) to determine whether fracture rates are higher among incident AP-Users receiving older, typical APs than among those receiving newer, atypical APs; 3) to perform pair-wise comparisons of fracture rates between the most commonly used AP drugs: haloperidol, risperidone, olanzapine, & quetiapine. Study Methods: This is a retrospective study of Medicaid-eligible NH residents in 5 states (CA, FL, NJ, MO, PA) during 1999, using three linked data sources. Medicaid pharmacy claims will provide AP drug exposure and dose information. Fractures will be identified in Medicare claims data using diagnosis and procedure codes. The Minimum Data Set (MDS) will provide demographic, clinical, and functional factors related to fracture risk. Unique facility identifiers for each NH will be included to allow adjustment for clustering effects. Comparison groups will be matched on State, age, gender, cognitive impairment score, and nursing facility, and then followed for hip fracture and non-hip fracture using survival analysis methods. Cox proportional hazards regression models with time-dependent covariates and shared frailty will be employed, adjusting for fracture risk factors as derived from an MDS-based validated fracture prediction model. The impact of AP drug dose will be examined using both the average dose and the last dose prescribed just before fracture. Doses will be expressed as a proportion of the maximal recommended dose for older adults to standardize values across drugs with different dosing ranges. Implications: Improved understanding of fracture patterns among NH residents using current AP drugs may contribute to improved AP prescribing decisions and enhanced quality of care for older adults with dementia.

描述（由申请人提供）：背景：跌倒相关骨折与疗养院 (NH) 居民的死亡率、发病率、功能下降和生活质量下降相关。 25% 的新罕布什尔州居民使用抗精神病 (AP) 药物来治疗痴呆相关的行为和心理症状。众所周知，AP 药物的使用与跌倒和骨折有关，但这些发现来自使用较旧的典型 AP 的研究。据报道，较新的非典型 AP 比较旧的典型 AP 具有更好的耐受性和更少的锥体外系副作用。由于快速采用对于新罕布什尔州环境中较新的非典型 AP，必须重新检查 AP 使用期间的骨折模式。大型观察数据集可用于检查短期临床试验中相对罕见的事件，例如骨折。研究目的： 1) 确定 AP 用户的骨折率（髋部骨折和非髋部骨折）是否高于非用户； 2) 确定接受较旧、典型 AP 的事件 AP 用户的骨折率是否比接受较新、非典型 AP 的用户更高； 3) 对最常用的 AP 药物之间的骨折率进行成对比较：氟哌啶醇、利培酮、奥氮平和喹硫平。研究方法：这是 1999 年对 5 个州（加利福尼亚州、佛罗里达州、新泽西州、密苏里州、宾夕法尼亚州）符合医疗补助资格的新罕布什尔州居民进行的一项回顾性研究，使用了三个链接的数据源。医疗补助药房索赔将提供 AP 药物暴露和剂量信息。将使用诊断和程序代码在医疗保险索赔数据中识别骨折。最小数据集 (MDS) 将提供与骨折风险相关的人口统计、临床和功能因素。独特的将包括每个 NH 的设施标识符，以便调整集群效应。比较组将在状态、年龄、性别、认知障碍评分和护理设施上进行匹配，然后使用生存分析方法对髋部骨折和非髋部骨折进行随访。将采用具有时间依赖性协变量和共同脆弱性的 Cox 比例风险回归模型，调整源自基于 MDS 的经过验证的骨折预测模型的骨折风险因素。 AP 药物剂量的影响将使用平均剂量和骨折前的最后一次处方剂量进行检查。剂量将表示为老年人最大推荐剂量的比例，以标准化不同剂量范围药物的值。意义：提高对使用当前 AP 药物的 NH 居民骨折模式的了解可能有助于改善 AP 处方决策并提高老年痴呆症患者的护理质量。