Status:
COMPLETED
COPD Readmissions Prediction- ReCOPD Project
Lead Sponsor:
Hospital Galdakao-Usansolo
Collaborating Sponsors:
Hospital de Basurto
Hospital Santa Marina
Conditions:
Pulmonary Disease, Chronic Obstructive, Severe Early-Onset
Eligibility:
All Genders
18+ years
Brief Summary
To develop predictive models for short-term readmission (60 days) and medium term (one year) for patients with an exacerbation of COPD (eCOPD) which are admitted to any of the participant hospitals. T...
Detailed Description
DESIGN: A prospective observational cohort study with a nested case control study, with one year follow-up from index hospital admission. SETTING: Multicenter and multidisciplinary study taking part ...
Eligibility Criteria
Inclusion
- Episodes of patients with exacerbation of chronic obstructive pulmonary disease (COPD). Those patients can be admitted with 2 presentations: A) known case of COPD: episodes of patients with a previous diagnosis of COPD (FEV1/FVC\<70%) who have an exacerbation of COPD. The exacerbation of COPD is defined as an acute worsening of symptoms in relation to the baseline situation and beyond the patient's daily variability. In addition, the exacerbation makes necessary to make changes in the patient's usual medication. The most frequently reported symptoms are dyspnea, cough, increased the sputum's production, and changes in the sputum's color. B) New case of COPD: episodes in which COPD is suspected because of the medical history and anamnesis (smokers or ex-smorkers of more than 15 pack/year, with basal dyspnea, cough, and expectoration for more than three months per year) and it is compatible with an exacerbation. The diagnosis will be confirmed at respiratory outpatient clinic within two months after discharge, by performing a spirometry when the patient is stable. If COPD is not confirmed in this consultation, the patient would be excluded from the study.
- Patients who sign informed consent.
Exclusion
- Patients admitted with obstructive or restrictive ventilatory failure due to another disease (asthma, consequences of tuberculosis, pachypleuritis, restrictive diseases).
- All COPD patients finally admitted for any other cause, other than exacerbation or complicated COPD.
- Patients with severe physical or psychopathological disease, cognitive deterioration, any neurologic disease, that prevented them from properly completing the questionnaires.
- Patients who do not understand the Spanish language to complete properly the questionnaires.
- Patients that do not want to participate or do not sign the inform consent.
- For re-admissions:
- \- Those who are programmed admissions or those for another cause not in relation with CMS algorithms.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03227211
Start Date
October 1 2016
End Date
June 30 2020
Last Update
January 13 2022
Active Locations (8)
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1
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, Spain
2
Hospital U. Cruces
Barakaldo, Spain
3
Hospital Santa Marina
Bilbao, Spain
4
Hospital U. Basurto
Bilbao, Spain