Reducing Adverse Drug Events in the Nursing Home
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- adverse drug events
研究概览
简要总结
Medications are the single most common form of treatment in the long-term care setting, and often represent the most efficacious (and cost-effective) therapeutic modality used in this clinical setting. However, the residents of nursing homes are at increased risk for experiencing adverse drug events. This risk is increased by the physiologic decline and pharmacologic changes that occur with aging, and also by the special clinical and social circumstances that characterize institutional long-term care. In a study funded by the National Institute on Aging (AG 14472), we have previously determined that adverse drug events are common and often preventable in the nursing home setting and that the more serious the adverse drug event, the more likely it is to be preventable. This study will test whether a computer-based clinical decision support system can lower the rate of adverse drug events (ADEs) and potential ADEs in the long-term care setting. The study design is a randomized trial based in the resident care units of two large long-term care facilities. Within each facility, half of the resident care units will be randomized to an intervention arm receiving the computer-based clinical decision support system which will display warnings, messages, and prompts based on resident and drug use characteristics; with over-rides by the prescriber required for some warnings. Rates of ADEs and potential ADEs will be tracked by the study's on-site clinical pharmacists prior to and during the intervention period. Rates will be compared between units receiving and not receiving the computer¬based clinical decision support system and to baseline, pre-intervention rates in the same units. We will track all project costs directly related to the development and installation of the computer-based clinical decision support system. We will also develop and test the sensitivity and specificity of a computerized adverse drug event monitor and assess the validity of a nursing home resident risk model developed in our prior study of adverse drug events in the nursing home setting.
详细描述
This study was conducted in two large, academic long-term care facilities located in Connecticut and Ontario, Canada. The two facilities have a combined total of 1,229 beds. Patients residing in areas of the facilities related to short-term care (e.g., subacute care, hospital-level care, or rehabilitation) were not included in the study population.
Each of the facilities had an existing computerized provider order entry system without a computer-based clinical decision support system. At the time of the study, approximately 90% of new medication orders were entered using the system. All medication prescribing was performed by contracted staff; in one of the study facilities this included 27 physicians, nurse practitioners, and physicians' assistants. In the other facility, medication prescribing was performed by 10 physicians.
Across the two long-term care facilities, 26 resident care units, each with existing computer provider order entry, were randomized to having a clinical decision support system (intervention units) or not (control units). Bed size of the resident care units ranged from 20 to 60 beds. An effort was made to match the units according to bed size and general characteristics of the residents on the units. We block randomized within categories including: dementia units, units where mental health and behavioral problems were common among the residents, units where the residents had complex medical needs, and units where the residents had profound deficits in physical function.
On intervention units, prescribers ordering drugs were presented with alerts in the form of warning messages; these alerts were not displayed to prescribers when ordering medications for residents of control units. Although efforts were initially made to limit crossover of prescribers between intervention and control units, over the duration of the study, there were providers working simultaneously on both types of units, both on a temporary (coverage) basis and also permanently.
The clinical decision support system was designed by a team of geriatricians, pharmacists, health services researchers, and information system specialists; the process of developing the clinical decision support system and its components has been described previously. The design principles were: 1) messages should be evidence-based; 2) messages should be perceived as useful and informative by practitioners; and 3) the system should have only modest impact on the time required for the practitioner to complete an order. The team reviewed the types of preventable adverse drug events based on previous research, as well as widely accepted published criteria for suboptimal prescribing in the elderly available at the time of this study. We also reviewed all serious drug-drug interactions from standard pharmaceutical drug interaction databases and included alerts for a limited number of more than 600 potentially serious interactions that were reviewed. Reasons for exclusion of alerts for specific drug interactions included that the medications were not on formulary at the facility, or that the medications were generally never used in elderly patients or in the long-term care setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •prescriber at the study facilities
排除标准
- •not a prescriber at the study facilities
结局指标
主要结局
adverse drug events
时间窗: March 2002 - February 2005
次要结局
未报告次要终点
