COPD Readmissions Prediction- ReCOPD Project

NCT03227211 | Completed DMC

• 1 other identifier: 15/00016
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 8

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. To identify factors contributing to readmission from the time of discharge from the index admission to the studied readmission time. Methodology. Design: Prospective cohort study with a nested case control study, with follow up to one year. Patients: 1500 patients admitted over a year and a half in any of the 9 participant hospitals by an eCOPD. Methods: During admission, background information on patient situation prior to admission, data of the ED during admission, and discharge planning, will be collected from medical history. The investigators will also survey patients (generic and specific health-related quality life -HRQoL- dependence, social support, presence of fragility). All patients will be followed to determining whether any readmission until 60 and up to one year of discharge from the index admission occurs. Patients readmitted at the first 60 days after discharge will be surveyed on a number of possible causes of readmission (continuity of care, medication, complications, individual and social factors). A one to one control group will be established to compare different factors studied in the case group (readmission). Statistical analysis: predictive models will be developed from the derivation sample, and validated in a validation sample. Also, the factors evaluated in the case-control study will be compared using appropriate test for paired samples.

Conditions

Pulmonary Disease, Chronic Obstructive, Severe Early-Onset

Keywords

COPD exacerbated; Readmission; Prospective cohort study; Nested case control study; Clinical prediction rules

Outcome Measures

Primary Outcomes (1)

• Readmission

  Hospital readmission

  60 days from index admission

Secondary Outcomes (3)

• Changes in HRQoL parameters

  Index admission to 60 days

• Readmissions

  One year from index admission

• Mortality

  One year from index admission

Study Arms (1)

COPD exacerbated patients admitted

No specific intervention

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 COPD admitted to any of the participant hospitals (Costa del Sol Hospital (Andalusia), Nuestra Señora de la Candelaria University Hospital (Canary Islands), Gregorio Marañón General University Hospital (Madrid), and Basque Country hospitals (Araba, Donostia, Basurto, Cruces University Hospitals and Santa Marina and Galdakao-Usansolo Hospitals) during the recruitment period who fulffill the selection criteria until the desired sample size is obtained.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Hospital de Basurto: collaborator
• Hospital Santa Marina: collaborator
• Hospital de Cruces: collaborator
• Hospital Donostia: collaborator
• Hospital Universitario Araba: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Univeritario Ntra. Sra. de la Candelaria: collaborator
• Hospital Costa del Sol: collaborator

Study Sites (8)

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain

Location

Hospital U. Cruces

Barakaldo, Spain

Location

Hospital Santa Marina

Bilbao, Spain

Location

Hospital U. Basurto

Bilbao, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Location

Hospital Ntra. Sra. de la Candelaria

Las Palmas de Gran Canaria, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Costa del Sol

Marbella, Spain

Location

Related Publications (1)

• Quintana JM, Anton-Ladislao A, Orive M, Aramburu A, Iriberri M, Sanchez R, Jimenez-Puente A, de-Miguel-Diez J, Esteban C; ReEPOC-REDISSEC group. Predictors of short-term COPD readmission. Intern Emerg Med. 2022 Aug;17(5):1481-1490. doi: 10.1007/s11739-022-02948-4. Epub 2022 Feb 28.

  PMID: 35224712 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

In three of the hospital participant a sample of blood has been collected in each index admission and stored in each Biobank with the purpose of stuying some biomarkers of inflamation. In these cases, the patient must sign a specific additional informed consent established by the Biobank. With each Biobank the method will be established for the recruitment and delivery of samples.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive, Severe Early-Onset

Study Officials

• Jose M Quintana, MD, PhD

  Chief of Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Research Unit

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: October 1, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: After all analysis related to the goals of the study have been performed and published
• Access Criteria: Based on our institution criteria

Locations

ES (8)