The Use of Antipsychotics in the Program of All-inclusive Care for the Elderly (PACE)
2019年9月9日 更新者：Tabula Rasa HealthCare
Antipsychotic Use Within the Program of All-inclusive Care for the Elderly (PACE)
The aim of this study is to retrospectively evaluate and describe the use of antipsychotics among participants enrolled in the Program of All-inclusive Care for the Elderly (PACE), a community-based practice setting.
研究概览
地位
完全的
条件
详细说明
Much national attention has been given to assessing and reducing the use of antipsychotics among nursing home residents, yet comparatively little attention has focused on antipsychotic use among older adults receiving care in community-based settings.
The primary objective of this study is to determine the prevalence of antipsychotic use among a nationally representative sample of nursing home-eligible older adults in a community-based practice setting known as Program of All-inclusive Care for the Elderly (PACE).
The secondary objectives are focused on characterizing antipsychotic use within PACE and for these participants.
Specifically, the investigator's secondary objectives are to describe patterns of other drugs concomitantly used with antipsychotics (e.g., benzodiazepines, opioids) and to identify clinically relevant drug-drug interactions involving antipsychotics.
研究类型
观察性的
注册 (实际的)
10000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New Jersey
-
Moorestown、New Jersey、美国、08057
- Tabula Rasa HealthCare
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Program of All-inclusive Care for the Elderly (PACE) is a Medicare-Medicaid program that provides comprehensive medical and supportive services to individuals >55 years of age who are certified by their state as needing nursing home care but are able to live safely in the community through PACE, as an alternative to institutionalization.
描述
Inclusion Criteria:
- Participant enrolled in PACE contractually receiving pharmacy services from Tabula Rasa Healthcare CareKinesis Pharmacy (Tabula Rasa HealthCare) during the project time period (January 2017 through December 2017).
Exclusion Criteria:
- Participant with a diagnosis of bipolar disorder and/or schizophrenia, according to pharmacy records.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：追溯
队列和干预
团体/队列 |
|---|
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Study group
Participants enrolled in PACE who received an antipsychotic medication.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of Antipsychotic Use
大体时间：12 months
|
Quantitative description of antipsychotic use as assessed by pharmacy records
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12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concomitant Drug Use with Antipsychotics
大体时间：12 months
|
Qualitative and quantitative description of patterns of other drugs concomitantly used with antipsychotics as assessed by pharmacy records
|
12 months
|
|
Drug-Drug Interactions
大体时间：12 months
|
Qualitative and quantitative description of drug-drug interactions involving antipsychotics as assessed by proprietary clinical decision support system (CDSS)
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kevin T Bain, PharmD, MPH、Tabula Rasa HealthCare
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bain KT, Schwartz EJ, Chan-Ting R. Reducing Off-Label Antipsychotic Use in Older Community-Dwelling Adults With Dementia: A Narrative Review. J Am Osteopath Assoc. 2017 Jul 1;117(7):441-450. doi: 10.7556/jaoa.2017.090.
- Pimentel CB, Donovan JL, Field TS, Gurwitz JH, Harrold LR, Kanaan AO, Lemay CA, Mazor KM, Tjia J, Briesacher BA. Use of atypical antipsychotics in nursing homes and pharmaceutical marketing. J Am Geriatr Soc. 2015 Feb;63(2):297-301. doi: 10.1111/jgs.13180.
- Liperoti R, Pedone C, Corsonello A. Antipsychotics for the treatment of behavioral and psychological symptoms of dementia (BPSD). Curr Neuropharmacol. 2008 Jun;6(2):117-24. doi: 10.2174/157015908784533860.
- Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA. 2005 Oct 19;294(15):1934-43. doi: 10.1001/jama.294.15.1934.
- Salvo F, Pariente A, Shakir S, Robinson P, Arnaud M, Thomas S, Raschi E, Fourrier-Reglat A, Moore N, Sturkenboom M, Hazell On Behalf Of Investigators Of The Aritmo Consortium L; Investigators of the ARITMO Consortium. Sudden cardiac and sudden unexpected death related to antipsychotics: A meta-analysis of observational studies. Clin Pharmacol Ther. 2016 Mar;99(3):306-14. doi: 10.1002/cpt.250. Epub 2015 Nov 20.
- Gareri P, De Fazio P, Manfredi VG, De Sarro G. Use and safety of antipsychotics in behavioral disorders in elderly people with dementia. J Clin Psychopharmacol. 2014 Feb;34(1):109-23. doi: 10.1097/JCP.0b013e3182a6096e.
- Mehta S, Johnson ML, Chen H, Aparasu RR. Risk of cerebrovascular adverse events in older adults using antipsychotic agents: a propensity-matched retrospective cohort study. J Clin Psychiatry. 2010 Jun;71(6):689-98. doi: 10.4088/JCP.09m05817yel.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2019年3月1日
研究注册日期
首次提交
2018年9月25日
首先提交符合 QC 标准的
2018年9月28日
首次发布 (实际的)
2018年10月2日
研究记录更新
最后更新发布 (实际的)
2019年9月10日
上次提交的符合 QC 标准的更新
2019年9月9日
最后验证
2019年9月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There will be no disclosure of participant information and no details of participant identity will be part of any presentation or publication of the research.
Participant confidentiality will be held in strict trust by the project investigators.
The project data or other information generated will be held in strict confidence.
No information concerning the project or the data will be released to any unauthorized third party without prior written consent.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.