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临床试验/NCT04740658
NCT04740658已完成不适用

Effect of Organizational Measures to Prevent and Control COVID-19 Infection in Nursing Homes on the Risk of Death of Residents During and After the Epidemic Period

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 12,166 人开始时间: 2021年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12,166
试验地点
1
主要终点
Death occurrence within one year of follow up

研究概览

简要总结

The COVID epidemic has shown very high mortality among older people, especially among poly-morbid and dependent subjects. In addition to the classic risk factors of age, dependence and associated co-morbidities, community life exposes to specific increased risks in the event of this easily inter human transmissible viral epidemic. In France, according to the Direction of research, studies, evaluation and statistics (DREES) data (Ehpa study, 2015) more than 600,000 elderly people currently live in nursing homes (NH). Since March 28, a national guidance for monitoring the COVID epidemic in NH has just been set up. In France, 14 178 of the 29 319 COVID deaths (48.35%) by June 10th 2020 occurred among NHs residents. Work to consolidate these data is underway, suggesting a much heavier balance sheet. Faced to this threat, in addition to practical recommendations (barrier protection gestures), strict instructions were also announced to all NH to keep their residents safe from COVID : restricting all visitors, all volunteers and nonessential personnel, and more recently, confining residents in their room in case of incident case of COVID in the NH. Organizational factors of NH such as the prevention strategies deployed before and during the epidemic (pneumococcal vaccination, restricting group activities), as well as NH internal resources (equipment, nursing staff) and health resources in the NH environment (hospital partnerships, support devices, telemedicine) lead to heterogeneous situations and could influence the death rates of residents. On the other hand, social isolation can also precipitate the decline of fragile residents. Beyond the immediate and directly risks linked to COVID-19, the present hypothesize that the organizational measures (guidance and recommendations) put in place can have, during and at a distance from the outbreak, beneficial effects but also deleterious effects depending on the severity of the outbreak of a geographic area. More precisely, the hypothesis is that strong and well-followed recommendations at the time of the epidemic were associated with a reduction in the risk of total death in particular of deaths related to COVID in the zones most affected by the epidemic but also that strong and well-followed recommendations were associated with an increased risk of total death, in particular of deaths unrelated to COVID in the areas least affected by the epidemic.

详细描述

The PIANO COVID-19 study is an observational, ambidirectional multicenter cohort study. The study will compare the death rates (COVID and non-COVID) in NHs according to the application of the general and specific recommendations of the region by the NH teams, taking into account the COVID infection rate in the NH department, the transfer capacities to hospitals, the medicalization of NH and the general characteristics of residents of NH. These parameters having been fluctuating over time, the analysis will also take into account the period considered.

3 sources of data will be used :

- Questionnaire: The NH team leaders will be asked to report variable related to the implementation of the recommendation/guidance by the nursing home staff, the general characteristics of the residents, and characteristics of the NH, and the monthly rate of death from January to December 2020.

A score will be built in regard to the implementation of the recommendation/guidance from the nursing home staff.

- Data related to the recommendations/guidance of the 13 regions of France (general guidance such as barriers measures and specificity guidance), the COVID infection rate in each NH department, the transfer capacities to hospitals and emergency department, will be collected by the PIANO COVID-19 research team.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Within each NH, all NH residents living in the NH the 1st of January 2020 will be included.

排除标准

  • NHs or Long Term Care Facilities (LTCFs) that refuse to participate.
  • NHs that are not voluntary or not located in the regions and NHs that do not have a coordinating doctor .
  • Within each NH, all NH residents not living in the NH or LTCFs the 1st of January 2020 will be not be included.

结局指标

主要结局

Death occurrence within one year of follow up

时间窗: from January 2020 to December 2020

* Primary criteria is death occurrence within one year of follow up: death rates will be recorded. * Level of implementation of the recommendation/guidance to prevent and control COVID-19 NH residents' infection will be score 14 days before the peak wave of the outbreak in the geographic area of each NH.

次要结局

  • deaths related to COVID during the one-year follow-up(from January 2020 to December 2020)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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