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临床试验/NCT04688372
NCT04688372已完成不适用

Association Between Hospital Case Burden and Mortality Risk Among Patients Hospitalized With COVID-19: A Retrospective Cohort Study of U.S. Hospitals

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 144,116 人开始时间: 2020年10月1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
144,116
试验地点
1
主要终点
In-hospital mortality or discharge to hospice

研究概览

简要总结

A retrospective cohort study will be conducted using a large administrative database of U.S. hospitals to understand the volume-outcome relationship among patients hospitalized with COVID-19.

详细描述

Patients with critical illness and/or respiratory failure tend to display better outcomes at hospitals that manage higher volumes of these patients. However, during a COVID-19 pandemic, this relationship may have been altered by the strain of higher patient volume on resources and personnel. A retrospective cohort study will be conducted using a large administrative database to understand the volume-outcome relationship among patients hospitalized with COVID-19. Understanding the COVID-19 volume-outcome relationship in U.S. hospitals may help identify the optimal care setting and transfer thresholds, and inform triage policies and risk-adjustment.

The Premier Healthcare Database (PHD), an all-payer administrative data repository covering approximately 20% of U.S. hospitalizations from 48 states will be queried for adult (18+ years) in-patient encounters that recorded diagnosis coding for COVID-19 March 1st through August 31st, 2020 at continuously-reporting hospitals. Hospitals with <15 COVID-19 encounters over the study period will be excluded from the primary cohort to preserve statistical reliability.

A surge index will be calculated for each hospital month that incorporates care-complexity-weighted COVID-19 case burden and will be normalized for nominal (2019) bed capacity and non-COVID-19 case burden and will represent the primary covariate. Hospital months will be stratified by the percentile of the surge index (e.g. <50th, 50-75th, 75-90th, 90-95th and ≥95th percentile).

The impact of COVID-19-case burden (surge index) on the risk-adjusted odds ratio (aOR) of mortality (or discharge to hospice) among overall COVID-19 cohorts will be determined using a hierarchical generalized linear mixed model controlling for case-mix, treatment-related, time-varying and other hospital-level factors. Variables will be selected based on their representing "baseline" status upon presentation to the hospital to minimize effect of mediators.

Variables for case mix adjustment: age, gender, race/ethnicity, comorbidity burden, insurance status, admission source and acuity, acute organ failure score and code status present-on-admission, use of pharmacologic agents (remdesivir, corticosteroids, hydroxychloroquine and azithromycin), severity of hypoxia (acute respiratory failure codes, need for non invasive positive pressure ventilation, need for invasive mechanical ventilation), vasopressor use within two days of admission respectively.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • See study description

排除标准

  • See study description

结局指标

主要结局

In-hospital mortality or discharge to hospice

时间窗: From time of admission to death during the hospitalization or discharge to hospice

次要结局

  • In-hospital mortality(From time of admission to death during the hospitalization)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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