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Appropriate Admission in COPD Exacerbation From Emergency Department. Multicenter Study (IRYSS-COPD)

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ClinicalTrials.gov Identifier: NCT02434536
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo

Brief Summary:

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.


Condition or disease
COPD

Show Show detailed description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2487 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: 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.
Study Start Date : October 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010



Primary Outcome Measures :
  1. Appropriateness of hospital admission [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ]
    Appropriateness judgement by specific RAND panel criteria


Secondary Outcome Measures :
  1. Readmission [ Time Frame: 2 months ]
    Hospital readmission

  2. Length of hospital stay [ Time Frame: Hospital admission ]
  3. Change in symptoms and HRQoL parameters [ Time Frame: Up to 2 months ]
    Changes in dyspnea, physical activity or EuroQol scores

  4. Mortality data [ Time Frame: 30 days; at admission or 7 days; at 2 months; at one year ]
    Death by any cause, or respiratory cause

  5. Intensive Care Unit admission [ Time Frame: Hospital admission ]
    admission to the intensive care unit, and/or requiring invasive or noninvasive

  6. Intermediate Respiratory Care Unit admission [ Time Frame: Hospital admission ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an exacerbation of chronic obstructive pulmonary disease attending the emergency departments (ED) of 16 hospitals in Spain
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Additional Information:

Publications of Results:
Bare M, Montón C, Pomares X, Font J, Torá N, Estirado C, Quintana JM, Santiago A, Vidal S, The Iryss-COPD appropiateness Study Group. Cohort study of factors contributing to mortality two months after exacerbation of COPD according to patient destination from emergency department. British Journal of Medicine and Medical Research 5(2):221-234, 2015
García-Gutiérrez S, Quintana JM, Unzurrunzaga A, Esteban C, González N, Barrio I. Creación de una escala para evaluar la gravedad de las exacerbaciones agudas de la enfermedad pulmonar obstructiva crónica (EA-EPOC) en los servicios de urgencias hospitalarios. Emergencias 26: 251-258, 2014.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JOSE M QUINTANA-LOPEZ, MD PhD, PhD, MD, Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier: NCT02434536    
Other Study ID Numbers: PI06/1010
061017, 06714, 060326, 0664 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria )
2012111008 ( Other Grant/Funding Number: Departamento de Sanidad del Gobierno Vasco )
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo:
Chronic Obstructive Pulmonary Disease
Disease Exacerbation Clinical Prediction Rule
Decision Analysis
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes