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：
7216810
负责人：
SALLY K RIGLER
金额：
$ 24.27万
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/7216810
关键词：
Adoption Adverse effects Age Antipsychotic Agents Behavior Therapy Behavioral Clinical Clinical Trials Code Data Data Set Data Sources Dementia Diagnosis Discipline of Nursing Disease regression Dose Drug Exposure Drug usage Elderly Event Fracture Gender Haloperidol Hip Fractures Hip region structure Impaired cognition Individual Link Long-Term Care Nursing Medicaid Medical Medicare Mental Health Methods Modeling Morbidity - disease rate Nurses Nursing Homes Outcome Pattern Persons Pharmaceutical Preparations Pharmacy facility Population Procedures Quality of Care Quality of life Randomized Range Rate Reporting Retrospective Studies Risk Risk Factors Risperidone Score Survival Analysis Symptoms Testing Time atypical antipsychotic base comparison group design falls frailty functional decline hazard improved mortality olanzapine prescription document prescription procedure psychologic quetiapine

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：与跌倒有关的裂缝与养老院（NH）居民的死亡率，发病率，功能下降和生活质量降低有关。 25％的NH居民使用抗精神病药（AP）药物来治疗与痴呆相关的行为和心理症状。已知AP药物的使用与跌倒和骨折有关，但是这些发现是从使用较旧的典型AP的研究得出的。据报道，与旧的典型AP相比，较新的非典型AP具有更好的耐受性和更少的腹膜外副作用。由于迅速采用 NH设置中的较新，非典型的AP，必须重新检查AP使用过程中的断裂模式。大型观察数据集可用于检查短期临床试验中可能相对罕见的骨折等事件。研究目的：1）确定入射司机的断裂率（髋关节和非骨架骨折）是否高于非用户； 2）确定接收较旧的典型AP的事件AP用户中的断裂率是否高于接受新的，非典型AP的裂缝率； 3）在最常用的AP药物之间对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：这是对1999年5个州（CA，FL，NJ，MO，PA）中符合医疗补助资格NH居民的回顾性研究，使用三个链接的数据源。医疗补助药房索赔将提供AP药物暴露和剂量信息。使用诊断和程序代码，将在Medicare索赔数据中确定断裂。最小数据集（MDS）将提供与破裂风险有关的人口，临床和功能因素。独特的每个NH的设施标识符将包括在内，以允许调整聚类效应。比较组将与状态，年龄，性别，认知障碍评分和护理设施相匹配，然后使用生存分析方法进行髋部骨折和非iph骨骨折。将采用具有时间依赖性协变量和共同脆弱的COX比例危害回归模型，并调整从基于MDS的经过验证的裂缝预测模型中得出的断裂风险因素。 AP药物剂量的影响将使用平均剂量和骨折之前的最后剂量进行检查。剂量将表示为老年人最大建议剂量的一部分，以使跨不同给药范围的药物进行标准化。含义：使用当前AP药物对NH居民中骨折模式的理解提高可能有助于改善AP处方决策和增强痴呆症老年人的护理质量。