COPD Clinical Trial
— IRYSS-COPDOfficial 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.
Verified date | August 2016 |
Source | Hospital Galdakao-Usansolo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 2487 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Galdakao-Usansolo |
Arostegui I, Esteban C, García-Gutierrez S, Bare M, Fernández-de-Larrea N, Briones E, Quintana JM; IRYSS-COPD Group. Subtypes of patients experiencing exacerbations of COPD and associations with outcomes. PLoS One. 2014 Jun 3;9(6):e98580. doi: 10.1371/jou — View Citation
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
Barrio I, Arostegui I, Quintana JM, Group IC. Use of generalised additive models to categorise continuous variables in clinical prediction. BMC Med Res Methodol. 2013 Jun 26;13:83. doi: 10.1186/1471-2288-13-83. — View Citation
Barrio I, Arostegui I, Rodríguez-Álvarez MX, Quintana JM. A new approach to categorising continuous variables in prediction models: Proposal and validation. Stat Methods Med Res. 2015 Sep 18. pii: 0962280215601873. [Epub ahead of print] — View Citation
Esteban C, Arostegui I, Garcia-Gutierrez S, Gonzalez N, Lafuente I, Bare M, Fernandez de Larrea N, Rivas F, Quintana JM; IRYSS-COPD Group. A decision tree to assess short-term mortality after an emergency department visit for an exacerbation of COPD: a co — View Citation
Esteban C, Quintana JM, Garcia-Gutierrez S, Anton-Ladislao A, Gonzalez N, Baré M, Fernández de Larrea N, Rivas-Ruiz F; IRYSS-COPD group. Determinants of change in physical activity during moderate-to-severe COPD exacerbation. Int J Chron Obstruct Pulmon D — View Citation
Garcia-Gutierrez S, Quintana JM, Aguirre U, Esteban C, Bilbao A, Escobar A, Vidal S, Bare M, Aizpuru F, Blasco JA; Investigación en Resultados y Servicios Sanitarios (IRYSS) COPD Group. Explicit criteria for hospital admission in exacerbations of chronic — View Citation
Garcia-Gutierrez S, Quintana JM, Barrio I, Bare M, Fernandez N, Vidal S, Gonzalez N, Lafuente I, Arteta E, Esteban C, Pulido E; IRYSS-COPD Appropriateness Study (IRYSS-CAS) group. Application of appropriateness criteria for hospitalization in COPD exacerb — View Citation
Garcia-Gutierrez S, Quintana JM, Bilbao A, Unzurrunzaga A, Esteban C, Baré M, Girón Moreno RM, Pulido E, Rivas P; IRYSS-COPD Appropriateness Study (IRYSS-COPD) Group. Validity of criteria for hospital admission in exacerbations of COPD. Int J Clin Pract. — View Citation
Garcia-Gutierrez S, Quintana JM, Unzurrunzaga A, Esteban C, Baré M, Fernández de Larrea N, Pulido E, Rivas P, -Copd Group I. Predictors of Change in Dyspnea Level in Acute Exacerbations of COPD. COPD. 2016 Jun;13(3):303-11. doi: 10.3109/15412555.2015.1078 — View Citation
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 hospitalar
Garcia-Gutierrez S, Unzurrunzaga A, Arostegui I, Quintana JM, Pulido E, Gallardo MS, Esteban C; IRYSS-COPD group. The Use of Pulse Oximetry to Determine Hypoxemia in Acute Exacerbations of COPD. COPD. 2015;12(6):613-20. doi: 10.3109/15412555.2014.995291. — View Citation
Pomares X, Montón C, Baré M, Pont M, Estirado C, Gea J, Quintana JM, Vidal S, Santiago A; IRYSS-COPD Appropriateness study group. Emergency Hospital Care for Exacerbation of COPD: Is Inhaled Maintenance Therapy Modified? COPD. 2016;13(1):11-8. doi: 10.310 — View Citation
Quintana JM, Esteban C, Barrio I, Garcia-Gutierrez S, Gonzalez N, Arostegui I, Lafuente I, Bare M, Blasco JA, Vidal S; IRYSS-COPD Group. The IRYSS-COPD appropriateness study: objectives, methodology, and description of the prospective cohort. BMC Health Serv Res. 2011 Nov 24;11:322. doi: 10.1186/1472-6963-11-322. — View Citation
Quintana JM, Esteban C, Garcia-Gutierrez S, Aguirre U, Gonzalez N, Lafuente I, Bare M, Fernandez de Larrea N, Rivas-Ruiz F; IRYSS-COPD Group. Predictors of hospital admission two months after emergency department evaluation of COPD exacerbation. Respirati — View Citation
Quintana JM, Esteban C, Unzurrunzaga A, Garcia-Gutierrez S, Gonzalez N, Barrio I, Arostegui I, Lafuente I, Bare M, Fernandez-de-Larrea N, Vidal S; IRYSS-COPD group. Predictive score for mortality in patients with COPD exacerbations attending hospital emer — View Citation
Quintana JM, Esteban C, Unzurrunzaga A, Garcia-Gutierrez S, Gonzalez N, Lafuente I, Bare M, de Larrea NF, Vidal S; IRYSS-COPD Group. Prognostic severity scores for patients with COPD exacerbations attending emergency departments. Int J Tuberc Lung Dis. 20 — View Citation
Quintana JM, Unzurrunzaga A, Garcia-Gutierrez S, Gonzalez N, Lafuente I, Bare M, de Larrea NF, Rivas F, Esteban C; IRYSS-COPD Group. Predictors of Hospital Length of Stay in Patients with Exacerbations of COPD: A Cohort Study. J Gen Intern Med. 2015 Jun;3 — View Citation
Rivas-Ruiz F, Redondo M, González N, Vidal S, García S, Lafuente I, Bare M, Cano Aguirre Mdel P, Quintana-López JM; Grupo IRYSS-COPD. Appropriateness of diagnostic effort in hospital emergency room attention for episodes of COPD exacerbation. J Eval Clin — View Citation
Vidal S, González N, Barrio I, Rivas-Ruiz F, Baré M, Blasco JA, Ruíz-Frutos C, Quintana JM; Investigación en Resultados y Servicios Sanitarios (IRYSS) COPD Group. Predictors of hospital admission in exacerbations of chronic obstructive pulmonary disease. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Appropriateness of hospital admission | Appropriateness judgement by specific RAND panel criteria | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Yes |
Secondary | Readmission | Hospital readmission | 2 months | Yes |
Secondary | Length of hospital stay | Hospital admission | Yes | |
Secondary | Change in symptoms and HRQoL parameters | Changes in dyspnea, physical activity or EuroQol scores | Up to 2 months | No |
Secondary | Mortality data | Death by any cause, or respiratory cause | 30 days; at admission or 7 days; at 2 months; at one year | Yes |
Secondary | Intensive Care Unit admission | admission to the intensive care unit, and/or requiring invasive or noninvasive | Hospital admission | Yes |
Secondary | Intermediate Respiratory Care Unit admission | Hospital admission | Yes |
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