跳至主要内容
临床试验/NCT02747121
NCT02747121已完成不适用

Effects of External Inspection on Sepsis Detection and Treatment

Norwegian Board of Health Supervision2 个研究点 分布在 1 个国家目标入组 7,407 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7,407
试验地点
2
主要终点
Number of Sepsis Patients With 30 Days Mortality

研究概览

简要总结

External inspections are widely used as means to improve the quality of care. Despite their widespread use, there is limited knowledge about whether and how they affect the quality of care. This study uses inspection with detection and treatment of sepsis in hospitals as a case to evaluate the effect of inspections on the quality of care and to explore how inspections affect the hospitals.

详细描述

The aim of this study is to assess what effect external inspections have on the quality of care provided to sepsis patients admitted to hospital and to explore how external inspections affect the involved organizations.

External inspections are widely used as a means to improve the quality of care, and it is a core element of regulatory regimes and certification and accreditation processes. The activity of assessing a health care organization's performance according to an externally defined standard has been described by partly overlapping terms such as external inspection, external review, supervision, and audit. The project uses the term external inspection implying that the inspection is initiated and controlled by an organization external to the one being inspected; and define it as: "a system, process or arrangement in which some dimensions or characteristics of a healthcare provider organisation and its activities are assessed or analysed against a framework of ideas, knowledge, or measures derived or developed outside that organisation".

In line with this definition the investigator intend to study how external inspection affect the quality of care provided on an organizational level. The project does not intend to study how external inspections can affect individuals in the organization nor individual professional development. The investigator takes the perspective that quality of care can be considered a system property, being dependent on how the organization providing care performs as a whole. Accordingly, improving the quality of care is dependent on changing the performance of the organization, which in turn implies change in organizational behavior and the way clinicians mutually interact and perform their clinical processes. Change in organizational behavior is a complex social process that involves a number of different practices on different organizational levels. If external inspection has the ability to contribute to improve the quality of care on an organizational level, it need to affect the practices involved in organizational change.

The effect of external inspection systems on the quality of care remains unclear and the evidence is contradictory. Studies have demonstrated a positive association between accreditation and the ability to promote change, professional development, quality systems, and clinical leadership. There is evidence to support an association between inspections and different quality outcomes e.g. reduced incidence of pressure ulcer and suicide. There are however also studies reporting that inspections have no impact on the quality of care. Inspection systems are widely used and much resources are spent on such systems worldwide. More knowledge about how and whether external inspections can effect the quality of care is needed.

The inspection process can be considered a complex intervention consisting of a set of activities that are introduced into varying organizational contexts. The inspection itself does not have a direct impact on the quality of care. If the inspection encounters non-compliant behavior, the inspected organization is responsible for implementing necessary changes. The way the inspection process affects the involved organization will thus influence how the inspected organizations pursue the following change process. The way external inspections affect the involved organization, is currently poorly understood. A better understanding of the underlying mechanisms for how inspection systems might contribute to improve the quality of care is needed. Such knowledge can improve the understanding of why effects of external inspections seem to vary, which in turn can facilitate the development of more effective ways of conducting inspections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

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

  • Suspected infection and minimum 2 SIRS criteria. If high leucocytes are one of the two criteria, then 3 SIRS criteria are needed.

排除标准

  • Patients below the age of 18 years.
  • Patients who do not pass through the emergency room.

结局指标

主要结局

Number of Sepsis Patients With 30 Days Mortality

时间窗: 30 days

We will still use 30-day mortality rate as our outcome measure. The new international sepsis definition will over time affect coding practice and we can therefore not use routine data from the National Patient Register to calculate the mortality rate. We will calculate the mortality rate based on the patient population we include in the study. We will compare mortality rates before and after the inspections.

次要结局

  • Hospital Length of Stay(Exact number of days for the length of stay was collected from the National Patient Registry. Since the outcome measure is length of stay, the time frame varies between patients. Time frame for observation periode was at least 12 months for each patient.)

研究者

发起方
Norwegian Board of Health Supervision
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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