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临床试验/NCT02434536
NCT02434536已完成不适用

Assessment of the Appropriateness Admission From Emergency Departments in the Exacerbation of COPD. Validity of Explicit Criteria and Study of the Variability Between Different Centers of NHS. Multicenter Study IRYSS-Appropriateness-COPD.

Hospital Galdakao-Usansolo0 个研究点目标入组 2,487 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,487
主要终点
Appropriateness of hospital admission

研究概览

简要总结

Objectives: To estimate the rate of appropriate hospital admissions , and of discharge to home episodes that would have been appropriate admissions to the hospital, on patients with exacerbations of their COPD by using appropriateness explicit criteria developed with the RAND appropriateness methodology. To evaluate the validity of those criteria by looking at their correlation with morbid-mortality, use of medications and health resources. To identify the variability in the appropriateness admission/discharge among the different centres participating on the study.

Methodology: Prospective observational cohort study. 1. The investigators will apply the previously developed explicit criteria to a sample of COPD exacerbations presented in each of the Emergency Department of each participating hospital (16 centres). 2. The investigators will evaluate if there is variability among centres by comparing their appropriateness rates. 3. To study the validity of the criteria, on those admitted the investigators will collect information on their evolution (length of stay, need of medication, quality of life), complications, vital status during their admission until discharge, and up to 2 months after the visit to the Emergency Department the vital status, complications, readmissions and quality of life. On those discharged to home from the Emergency Department, the investigators will check the presence of complications, vital status, readmissions and quality of life. People trained will collect all the needed information, in the Emergency Department, during their admission, or by personal interview to all discharged to home and to all at 2 months after the visit to the Emergency Department.

详细描述

A prospective cohort study was performed to validate the explicit criteria developed by the RAM. Other goals for the cohort study were: to predict mortality, ICU or IRCU admission, hospital length of stay, changes in symptoms and to evaluate variability among hospitals in the appropriateness of hospital admission of patients experiencing COPD exacerbations and to study variability in access to care and outcomes. Sixteen hospitals belonging to the Spanish National Health Service agreed to participate: Hospital Costa del Sol, Hospital Valme, Hospital de Motril, Corporació Sanitaria Parc Taulí, Hospital del Mar, Hospital Universitario de La Princesa, Hospital Universitario Gregorio Marañón, Hospital Universitario La Paz, Hospital de Móstoles, Hospital Marqués de Valdecilla, Hospital Santa Marina, Hospital San Eloy, Hospital Galdakao-Usansolo, Hospital Txagorritxu, Complejo Hospitalario Donostia, and Hospital Cruces.

Patients attending the EDs of any of the 16 hospitals with an exacerbation of COPD were informed of the goals of the study and invited to voluntarily participate in it. All information was kept confidential. The Institutional Review Boards of the participating hospitals approved this project. Recruitment started in June 2008 and ended in September 2010.

Patients were candidates for the study if they presented to the ED of any of the participating hospitals with symptoms consistent of an exacerbation of COPD. Exacerbation was defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that was beyond normal day-to-day variations, was acute in onset, and may have warranted a change in regular medication in a patient with underlying COPD. Two possible presentations were considered:

Existing COPD. Patients were considered to have been previously diagnosed with COPD if they had a FEV1/forced vital capacity (FVC) quotient <70%, and a negative bronchodilation test with FEV1 change <200 mL and under 15% of the baseline value.

New COPD. Patients not previously diagnosed with COPD but in whom the disease was suspected were also eligible for inclusion in the study. This included smokers or former smokers of more than 15 packs per year with dyspnea, cough, or expectoration for more than three months per year, and experiencing symptoms resembling a clinical manifestation compatible with COPD exacerbation. The diagnosis had to be confirmed by spirometry within 60 days after the index episode at a time when the patient was stable, i.e., the absence of any increase in symptoms or changes in background therapy. If a diagnosis of COPD was not confirmed, the patient was excluded from the study.

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

  • Patients were eligible for the study if they presented to the Emergency Department with symptoms consistent of an exacerbation COPD. COPD was confirmed if the patient had a forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) quotient <70%. When COPD was newly diagnosed during the Emergency Department visit, to be included in the study a patient had to have COPD confirmed by spirometry within 60 days of the index episode at a time when he or she was stable.

排除标准

  • Patients were excluded from the study if, at the time they were seen in the Emergency Department , the exacerbation COPD was complicated by a comorbidity such as pneumonia, pneumothorax, pulmonary embolism, lung cancer, or left cardiac failure. Patients who did not wish to participate were also excluded.

结局指标

主要结局

Appropriateness of hospital admission

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 6 days

Appropriateness judgement by specific RAND panel criteria

次要结局

  • Readmission(2 months)
  • Length of hospital stay(Hospital admission)
  • Change in symptoms and HRQoL parameters(Up to 2 months)
  • Mortality data(30 days; at admission or 7 days; at 2 months; at one year)
  • Intensive Care Unit admission(Hospital admission)
  • Intermediate Respiratory Care Unit admission(Hospital admission)

研究者

发起方
Hospital Galdakao-Usansolo
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

JOSE M QUINTANA-LOPEZ, MD PhD

PhD, MD

Hospital Galdakao-Usansolo

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