Appropriate Admission in COPD Exacerbation From Emergency Department. Multicenter Study

NCT02434536 | Completed

• 3 other identifiers: PI06/1010061017, 06714, 060326, 06642012111008
• Study Type: observational
• Target: 2,487
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Keywords

Chronic Obstructive Pulmonary Disease; Disease Exacerbation Clinical Prediction Rule; Decision Analysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Related Publications (21)

• 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.

  PMID: 22115318 BACKGROUND

• Esteban C, Quintana JM, Garcia-Gutierrez S, Anton-Ladislao A, Gonzalez N, Bare M, Fernandez 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 Dis. 2016 Feb 3;11:251-61. doi: 10.2147/COPD.S79580. eCollection 2016.

  PMID: 26893555 RESULT

• 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 cohort study. Respir Res. 2015 Dec 22;16:151. doi: 10.1186/s12931-015-0313-4.

  PMID: 26695935 RESULT

• Garcia-Gutierrez S, Quintana JM, Unzurrunzaga A, Esteban C, Bare M, Fernandez 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: 10.3109/15412555.2015.1078784. Epub 2015 Dec 14.

  PMID: 26667827 RESULT

• Pomares X, Monton C, Bare 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: 10.3109/15412555.2015.1043517. Epub 2015 Sep 29.

  PMID: 26417965 RESULT

• Barrio I, Arostegui I, Rodriguez-Alvarez MX, Quintana JM. A new approach to categorising continuous variables in prediction models: Proposal and validation. Stat Methods Med Res. 2017 Dec;26(6):2586-2602. doi: 10.1177/0962280215601873. Epub 2015 Sep 18.

  PMID: 26384514 RESULT

• Rivas-Ruiz F, Redondo M, Gonzalez N, Vidal S, Garcia S, Lafuente I, Bare M, Cano Aguirre Mdel P, Quintana-Lopez JM; Grupo IRYSS-COPD. Appropriateness of diagnostic effort in hospital emergency room attention for episodes of COPD exacerbation. J Eval Clin Pract. 2015 Oct;21(5):848-54. doi: 10.1111/jep.12390. Epub 2015 Jul 2.

  PMID: 26139468 RESULT

• 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. Epub 2015 Mar 16.

  PMID: 25774875 RESULT

• 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. 2014 Dec;18(12):1415-20. doi: 10.5588/ijtld.14.0312.

  PMID: 25517805 RESULT

• 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;30(6):824-31. doi: 10.1007/s11606-014-3129-x. Epub 2014 Dec 4.

  PMID: 25472508 RESULT

• 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. Respiration. 2014;88(4):298-306. doi: 10.1159/000365996. Epub 2014 Sep 10.

  PMID: 25228470 RESULT

• Garcia-Gutierrez S, Quintana JM, Bilbao A, Unzurrunzaga A, Esteban C, Bare M, Giron 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. 2014 Jul;68(7):820-9. doi: 10.1111/ijcp.12397. Epub 2014 Feb 20.

  PMID: 25077290 RESULT

• 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 emergency departments. BMC Med. 2014 Apr 23;12:66. doi: 10.1186/1741-7015-12-66.

  PMID: 24758312 RESULT

• Vidal S, Gonzalez N, Barrio I, Rivas-Ruiz F, Bare M, Blasco JA, Ruiz-Frutos C, Quintana JM; Investigacion en Resultados y Servicios Sanitarios (IRYSS) COPD Group. Predictors of hospital admission in exacerbations of chronic obstructive pulmonary disease. Int J Tuberc Lung Dis. 2013 Dec;17(12):1632-7. doi: 10.5588/ijtld.13.0177.

  PMID: 24200281 RESULT

• 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 exacerbation. Intern Emerg Med. 2013 Jun;8(4):349-57. doi: 10.1007/s11739-013-0927-9. Epub 2013 Mar 19.

  PMID: 23508735 RESULT

• Garcia-Gutierrez S, Quintana JM, Aguirre U, Esteban C, Bilbao A, Escobar A, Vidal S, Bare M, Aizpuru F, Blasco JA; Investigacion en Resultados y Servicios Sanitarios (IRYSS) COPD Group. Explicit criteria for hospital admission in exacerbations of chronic obstructive pulmonary disease. Int J Tuberc Lung Dis. 2011 May;15(5):680-6. doi: 10.5588/ijtld.10.0408.

  PMID: 21756522 RESULT

• 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

  RESULT

• Arostegui I, Esteban C, Garcia-Gutierrez S, Bare M, Fernandez-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/journal.pone.0098580. eCollection 2014.

  PMID: 24892936 RESULT

• 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.

  PMID: 23802742 RESULT

• 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.

  RESULT

• Arostegui I, Legarreta MJ, Barrio I, Esteban C, Garcia-Gutierrez S, Aguirre U, Quintana JM; IRYSS-COPD Group. A Computer Application to Predict Adverse Events in the Short-Term Evolution of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease. JMIR Med Inform. 2019 Apr 17;7(2):e10773. doi: 10.2196/10773.

  PMID: 30994471 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 5, 2015
• Study Start: October 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 24, 2016

Record last verified: 2016-08