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临床试验/NCT03253640
NCT03253640已完成不适用

Evaluation of Cost of Nosocomial Infection

Glasgow Caledonian University2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2018年6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
123
试验地点
2
主要终点
Length of stay in hospital

研究概览

简要总结

This study will investigate the cost and impact of Healthcare Associated Infection (HAI) to patients, the health service and the wider community.

This is in order to develop a model to allow policy makers to compare the cost effectiveness of Infection Prevention and Control measures in NHSScotland. The model will support policy makers and clinical teams in building a patient centred, safe, effective and efficient service.

详细描述

Healthcare associated infection (HAI) also known as Nosocomial Infection (NI) is costly to the NHS and distressing to patients. It leads to increased morbidity and mortality, increased length of stay and often requires additional treatments. Information on the impact in terms of additional cost of treatment, reduction in quality of life and cost to society is not fully described. This study will collect epidemiological and economic data on patients with and without HAI and develop a framework around which the cost effectiveness of a range of Infection Prevention and Control (IPC) interventions can be assessed.

The study will be delivered as 4 distinct but overlapping work Phases Phase 1 will describe the incidence of HAI (defined by ECDC case definitions) in an admission cohort. This phase is a surveillance project.

Phase 2: Will describe the impact of HAI on care in hospital -as many patients as possible who acquired HAI and twice as many non-HAI comparators will be recruited. Patients or their guardians or nearest relative will be told about the study and asked if they are willing to provide consent to complete a number of questionnaires. This phase will include case note review by ECONI research nurses and a patient questionnaire.

Phase 3: Will investigate the impact of HAI on patient care post discharge (use of Health and Social Care resources outside of Hospital), Quality of Life and personal expenses) - questionnaire to patients to ask about impact on their overall health and wellbeing and personal expenses. This will involve patients completing a paper questionnaire at one, three, six and twelve months after they have been discharged from hospital. This phase will include a nested qualitative study which will interview 20-30 patients who acquired HAI to further investigate the impact of HAI on their lives and livelihoods Phase 4: This phase will not involve any patient interaction. It will develop a framework to support modelling for decision making for future investment in Infection Prevention and Control (IPC) based on data collected within Phase one to three above. The information collected during the first three phases will be used to model possible outcomes of infection prevention and control measures. This will be a modelling exercise using data collected within Phase 1, 2 and 3 and the protocol for this work will be described elsewhere.

Phase 2 and 3 will be a cohort of as many patients as possible with HAI and a sample of non-HAI patients (twice the number of HAI patients) who consent to participate in the study within the year of recruitment.

研究设计

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

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

  • Admitted to hospital for an overnight stay at study hospital
  • Subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving consent on the subject's behalf
  • 18 years old and over
  • Patients without HAI will not be re-recruited into the study. Patients who have HAI on a subsequent admission will not be re-recruited but will be asked to complete a baseline data collection form (see below for discussion) NOTE: we do need to ensure this is clear within the ethics application.
  • Good English language skills (sufficient to read and understand the participant information sheet without help)

排除标准

  • Admitted to hospital as a day case
  • Admitted to Hospitals other than the study hospitals
  • Under 18 years
  • Admitted to the study hospital during the study period and recruited to the study during a previous stay. See below
  • Subjects not capable of giving informed consent unless legal representative or relative can provide proxy consent
  • Patients who do not have English language skills to read and understand the information sheet without help

结局指标

主要结局

Length of stay in hospital

时间窗: All patient stays during the study year

Date of admission to discharge

Acquisition of healthcare associated infection

时间窗: During hospital stay, within one year post discharge for two hospital sites

Number of patients who develop new HAI Defined using ECDC HAI case definitions, and including costs of care in hospital, post discharge and impact of usual activity, ability to work and social care.

Quality of Life

时间窗: Utility score during hospital stay for HAI and non_HAI patients during hospital stay, one month post discharge and three months post discharge

Quality of life will be measured using SF-12 and EQ-5D validated questionnaires

Healthcare utilisation

时间窗: One year post discharge from hospital visit when recruited

Includes, specialty, antibiotic use, operations, post discharge health visits, community prescribing, out patient clinic attendance, re-admission to hospital

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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