<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227211</url>
  </required_header>
  <id_info>
    <org_study_id>15/00016</org_study_id>
    <nct_id>NCT03227211</nct_id>
  </id_info>
  <brief_title>COPD Readmissions Prediction- ReCOPD Project</brief_title>
  <acronym>ReCOPD</acronym>
  <official_title>Readmissions and Evolution Prediction Models in Patients Admitted to Hospital With COPD Exacerbations - ReCOPD Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Galdakao-Usansolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Basurto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Santa Marina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Cruces</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Donostia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Araba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Univeritario Ntra. Sra. de la Candelaria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Costa del Sol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Galdakao-Usansolo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To develop predictive models for short-term readmission (60 days) and medium term (one year)&#xD;
      for patients with an exacerbation of COPD (eCOPD) which are admitted to any of the&#xD;
      participant hospitals. To identify factors contributing to readmission from the time of&#xD;
      discharge from the index admission to the studied readmission time. Methodology. Design:&#xD;
      Prospective cohort study with a nested case control study, with follow up to one year.&#xD;
      Patients: 1500 patients admitted over a year and a half in any of the 9 participant hospitals&#xD;
      by an eCOPD. Methods: During admission, background information on patient situation prior to&#xD;
      admission, data of the ED during admission, and discharge planning, will be collected from&#xD;
      medical history. The investigators will also survey patients (generic and specific&#xD;
      health-related quality life -HRQoL- dependence, social support, presence of fragility). All&#xD;
      patients will be followed to determining whether any readmission until 60 and up to one year&#xD;
      of discharge from the index admission occurs. Patients readmitted at the first 60 days after&#xD;
      discharge will be surveyed on a number of possible causes of readmission (continuity of care,&#xD;
      medication, complications, individual and social factors). A one to one control group will be&#xD;
      established to compare different factors studied in the case group (readmission). Statistical&#xD;
      analysis: predictive models will be developed from the derivation sample, and validated in a&#xD;
      validation sample. Also, the factors evaluated in the case-control study will be compared&#xD;
      using appropriate test for paired samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      DESIGN: A prospective observational cohort study with a nested case control study, with one&#xD;
      year follow-up from index hospital admission.&#xD;
&#xD;
      SETTING: Multicenter and multidisciplinary study taking part the following hospitals: Costa&#xD;
      del Sol Hospital (Andalusia), Nuestra Señora de la Candelaria University Hospital (Canary&#xD;
      Islands), Gregorio Marañón General University Hospital (Madrid), and Basque Country hospitals&#xD;
      (Araba, Donostia, Basurto, Cruces University Hospitals and Santa Marina and Galdakao-Usansolo&#xD;
      Hospitals).&#xD;
&#xD;
      SUBJECTS: In this study episodes will be considered from the index episode of the admission&#xD;
      of the COPD exacerbated recruited patient.&#xD;
&#xD;
      Inclusion criteria: episodes of patients with exacerbation of chronic obstructive pulmonary&#xD;
      disease (COPD). Those patients can be admitted with 2 presentations: A) known case of COPD:&#xD;
      episodes of patients with a previous diagnosis of COPD (FEV1/FVC&lt;70%) who have an&#xD;
      exacerbation of COPD. The exacerbation of COPD is defined as an acute worsening of symptoms&#xD;
      in relation to the baseline situation and beyond the patient's daily variability. In&#xD;
      addition, the exacerbation makes necessary to make changes in the patient's usual medication.&#xD;
      The most frequently reported symptoms are dyspnea, cough, increased the sputum's production,&#xD;
      and changes in the sputum's color. B) New case of COPD: episodes in which COPD is suspected&#xD;
      because of the medical history and anamnesis (smokers or ex-smorkers of more than 15&#xD;
      pack/year, with basal dyspnea, cough, and expectoration for more than three months per year)&#xD;
      and it is compatible with an exacerbation. The diagnosis will be confirmed at respiratory&#xD;
      outpatient clinic within two months after discharge, by performing a spirometry when the&#xD;
      patient is stable. If COPD is not confirmed in this consultation, the patient would be&#xD;
      excluded from the study.&#xD;
&#xD;
      Patients who sign informed consent. Exclusion criteria: patients admitted with obstructive or&#xD;
      restrictive ventilatory failure due to another disease (asthma, consequences of tuberculosis,&#xD;
      pachypleuritis, restrictive diseases). All COPD patients finally admitted for any other&#xD;
      cause, other than exacerbation or complicated COPD. Patients with severe physical or&#xD;
      psychopathological disease, cognitive deterioration, any neurologic disease, that prevented&#xD;
      them from properly completing the questionnaires. Patients who do not understand the Spanish&#xD;
      language to complete properly the questionnaires. Patients that do not want to participate or&#xD;
      do not sign the inform consent. For re-admissions: those who are programmed admissions or&#xD;
      those for another cause not in relation with CMS algorithms.&#xD;
&#xD;
      SAMPLE SIZE: Calculation of sample size: predictive modeling studies establish that it is&#xD;
      necessary to have at least 10 events of the dependent variable of interest (readmissions) for&#xD;
      each independent variable included in the multivariate model. In the multivariate logistic&#xD;
      regression models, for the assessment of not less than 5 but not more than 10 variables, the&#xD;
      investigators estimate that it will be necessary at least 100 events of the dependent&#xD;
      variable (Readmissions) in the sample from which the investigators will derive the prediction&#xD;
      rule to ensure that the model converges properly. With a 20% of readmissions, and requiring&#xD;
      two samples (derivation and validation) the investigators need at least 1000 valid&#xD;
      admissions. On the other hand, in the nested case-control study, to detect differences in the&#xD;
      continuity of care at follow-up, from 70 to 55%, or in conciliation with medication from 30&#xD;
      to 15%, separately for case (readmissions) and control groups, less than 200 valid patients&#xD;
      would be needed for the analysis in each group (for and α=0.05 and a power (1-β) of 0.80),&#xD;
      which suppose 1000 index admissions. To do this, each center will have to collect&#xD;
      approximately 100-250 patients during the recruitment period. This is assured, while assuming&#xD;
      a 20% of exclusions, including those cases that are programmed admissions, and 15% of losses&#xD;
      on the remaining sample. Sampling: consecutive, all patients who re-enter and renter during&#xD;
      the study period.&#xD;
&#xD;
      METHODS: Variables to be included in the study: Variables to be collected from the Emergency&#xD;
      Department: 1) level of awareness measured by Glasgow scale, baseline and admission dyspnea&#xD;
      (MRC dyspnea and Borg fatigue scales), respiratory and cardiac frequency, blood pressure,&#xD;
      fever, thoracic pain, gasometric parameters (arterial oxygen (PO2) or oxygen saturation&#xD;
      (spoO2), pH, arterial carbon dioxide level (PCO2)); Variables to be collected during&#xD;
      admission: 2) Background and sociodemographic (age, sex); health habits (smoking, exercise&#xD;
      level), hearing or visual deficits, or falls; social support; 3) baseline COPD severity&#xD;
      (measured by FEV1, 5), emergency visits in the last month and year, and previous admissions&#xD;
      during the last 12 months; 4) Associated diseases that affect the exacerbation of COPD&#xD;
      (cardiac, diabetes), and all those that the Charlson Comorbidity index; 5)Weight, height&#xD;
      (BMI); 6)electrocardiography data, radiological findings, biochemical data and hematocrit,&#xD;
      gasometry, FIO2 on arrival and discharge; 7) Other: basal treatment in the Emergency&#xD;
      Department, and in the admission (short and/or long-term beta inhalers, anticholinergics,&#xD;
      inhaled and/or oral orticoid, oxygen therapy), antibiotics, and other medications necessary&#xD;
      for comorbidities; ICU admission, invasive mechanical ventilation; 8) presence of&#xD;
      complications, or death; Variables to be collected at admission and until discharge: ECG,&#xD;
      radiography at discharge, physiological data (temperature, respiratory and cardiac frequency,&#xD;
      blood preassure), biochemical data and hematocrit, gasometry and/or pulsimetry. Length of&#xD;
      hospital stay. Non-invasive ventilation or oxygen therapy at home. Health care habits&#xD;
      (tobacco, diet, exercise), specialist or family physician assessment, and, if available, a&#xD;
      review of inhalers using technique.&#xD;
&#xD;
      Self-administered questionnaires to be completed by the patient during admission&#xD;
&#xD;
        -  Assessment of the quality of life. EuroQol-5d generic questionnaire; specific&#xD;
           questionnaire: COPD Assessment test (CAT).&#xD;
&#xD;
        -  Symptoms´ assessment: MRC Dyspnea Scales; Physical Activity Questionnaire made ad hoc.&#xD;
&#xD;
        -  Anxiety/depression assessment: HAD questionnaire.&#xD;
&#xD;
        -  Social dependency: -Duke-UNC Social Support Scale&#xD;
&#xD;
        -  Fragility assessment: Tilburg Frailty Indicator Part B (Components of frailty)&#xD;
&#xD;
        -  Activities of daily living: Barthel's test. Variables to be collected from 2 months and&#xD;
           until one year of follow-up: through the participants hospitals' computer systems&#xD;
           (electronic medical history) and/or medical record on paper, and of the national death&#xD;
           index it will be collected basic information of the new readmissions (cause, date,&#xD;
           duration and complications) or patient's death.&#xD;
&#xD;
      DATA COLLECTED. A) Patients recruitment: trained personnel, with help/supervision of the&#xD;
      hospitals' respiratory specialist, will consecutively and prospectively recruit patients at&#xD;
      each center that meet the inclusion criteria. For each patient, the data collector will be&#xD;
      introduced to each patient to inform about the study aims', and if the patient agree to&#xD;
      participate, and sign the inform consent, HRQoL questionnaires will be given. The&#xD;
      questionnaires should be completed by the patient itself or with the help of a family member&#xD;
      or caregiver. The data collector will establish when to get back the questionnaires. If the&#xD;
      patients have been discharged, the questionnaires will be mailed. B) Clinical data&#xD;
      collection: Information will be collected from the Emergency Department and later, from the&#xD;
      medical record during admission and up to discharge. C) Identification of readmissions in the&#xD;
      first two months: The same data collector described above will examine the readmission from&#xD;
      the discharge to 60 days from it, to detect patients who are re-admitted. This will be&#xD;
      identified as readmission, and simultaneously, a patient that will be act as control and who&#xD;
      has been admitted at the same week as the patient with the current readmission will be&#xD;
      searched, trying to match both patients by age (by categories of five years) and baseline&#xD;
      FEV1 (greater or less than 50). All patients who have been readmitted within two months, and&#xD;
      their established controls, will be immediately mailed the follow-up questionnaire (the&#xD;
      corresponding questionnaire according if is case-readmission- or control situation). They&#xD;
      will be phoned in advance to advise them of the mailing of the questionnaires. The&#xD;
      questionnaires will be hand-delivered in the case of the patient hospital admitted at that&#xD;
      time. If within 7/10 days the questionnaire has not been received, a reminder letter will be&#xD;
      sent, and if in another 7/10 days the questionnaire has not been yet received, a letter with&#xD;
      the questionnaire will it be sent again. D) One year follow-up: Of all the patients recruited&#xD;
      in the index admission, whether they were readmissions, controls or not, clinical data will&#xD;
      be completed up to the year. E) Blood sample: In three of the hospital participant a sample&#xD;
      of blood has been collected in each index admission and stored in each Biobank. In these&#xD;
      cases, the patient must sign a specific additional informed consent established by the&#xD;
      Biobank. With each Biobank the method will be established for the recruitment and delivery of&#xD;
      samples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission</measure>
    <time_frame>60 days from index admission</time_frame>
    <description>Hospital readmission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in HRQoL parameters</measure>
    <time_frame>Index admission to 60 days</time_frame>
    <description>Changes from baseline-index admission- to 60 days in the scores of the different HRQoL questionnaires used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>One year from index admission</time_frame>
    <description>Hospital readmissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>One year from index admission</time_frame>
    <description>Death, by any cause or by respiratory cause</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1500</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive, Severe Early-Onset</condition>
  <arm_group>
    <arm_group_label>COPD exacerbated patients admitted</arm_group_label>
    <description>No specific intervention</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      In three of the hospital participant a sample of blood has been collected in each index&#xD;
      admission and stored in each Biobank with the purpose of stuying some biomarkers of&#xD;
      inflamation. In these cases, the patient must sign a specific additional informed consent&#xD;
      established by the Biobank. With each Biobank the method will be established for the&#xD;
      recruitment and delivery of samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an exacerbation of COPD admitted to any of the participant hospitals (Costa&#xD;
        del Sol Hospital (Andalusia), Nuestra Señora de la Candelaria University Hospital (Canary&#xD;
        Islands), Gregorio Marañón General University Hospital (Madrid), and Basque Country&#xD;
        hospitals (Araba, Donostia, Basurto, Cruces University Hospitals and Santa Marina and&#xD;
        Galdakao-Usansolo Hospitals) during the recruitment period who fulffill the selection&#xD;
        criteria until the desired sample size is obtained.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Episodes of patients with exacerbation of chronic obstructive pulmonary disease&#xD;
             (COPD). Those patients can be admitted with 2 presentations: A) known case of COPD:&#xD;
             episodes of patients with a previous diagnosis of COPD (FEV1/FVC&lt;70%) who have an&#xD;
             exacerbation of COPD. The exacerbation of COPD is defined as an acute worsening of&#xD;
             symptoms in relation to the baseline situation and beyond the patient's daily&#xD;
             variability. In addition, the exacerbation makes necessary to make changes in the&#xD;
             patient's usual medication. The most frequently reported symptoms are dyspnea, cough,&#xD;
             increased the sputum's production, and changes in the sputum's color. B) New case of&#xD;
             COPD: episodes in which COPD is suspected because of the medical history and anamnesis&#xD;
             (smokers or ex-smorkers of more than 15 pack/year, with basal dyspnea, cough, and&#xD;
             expectoration for more than three months per year) and it is compatible with an&#xD;
             exacerbation. The diagnosis will be confirmed at respiratory outpatient clinic within&#xD;
             two months after discharge, by performing a spirometry when the patient is stable. If&#xD;
             COPD is not confirmed in this consultation, the patient would be excluded from the&#xD;
             study.&#xD;
&#xD;
          -  Patients who sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients admitted with obstructive or restrictive ventilatory failure due to another&#xD;
             disease (asthma, consequences of tuberculosis, pachypleuritis, restrictive diseases).&#xD;
&#xD;
          -  All COPD patients finally admitted for any other cause, other than exacerbation or&#xD;
             complicated COPD.&#xD;
&#xD;
          -  Patients with severe physical or psychopathological disease, cognitive deterioration,&#xD;
             any neurologic disease, that prevented them from properly completing the&#xD;
             questionnaires.&#xD;
&#xD;
          -  Patients who do not understand the Spanish language to complete properly the&#xD;
             questionnaires.&#xD;
&#xD;
          -  Patients that do not want to participate or do not sign the inform consent.&#xD;
&#xD;
        For re-admissions:&#xD;
&#xD;
        - Those who are programmed admissions or those for another cause not in relation with CMS&#xD;
        algorithms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose M Quintana, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief of Research Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Araba</name>
      <address>
        <city>Gasteiz / Vitoria</city>
        <state>Alava</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital U. Cruces</name>
      <address>
        <city>Barakaldo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Marina</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital U. Basurto</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>Donostia / San Sebastián</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ntra. Sra. de la Candelaria</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Costa del Sol</name>
      <address>
        <city>Marbella</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>January 12, 2022</last_update_submitted>
  <last_update_submitted_qc>January 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Galdakao-Usansolo</investigator_affiliation>
    <investigator_full_name>JOSE M QUINTANA-LOPEZ, MD PhD</investigator_full_name>
    <investigator_title>Chief of Research Unit</investigator_title>
  </responsible_party>
  <keyword>COPD exacerbated</keyword>
  <keyword>Readmission</keyword>
  <keyword>Prospective cohort study</keyword>
  <keyword>Nested case control study</keyword>
  <keyword>Clinical prediction rules</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data base will be allocated in a public server once main analysis have been done</ipd_description>
    <ipd_time_frame>After all analysis related to the goals of the study have been performed and published</ipd_time_frame>
    <ipd_access_criteria>Based on our institution criteria</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227211
org study id: 15/00016
nct id: NCT03227211
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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 the following 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).

      SUBJECTS: In this study episodes will be considered from the index episode of the admission
      of the COPD exacerbated recruited patient.

      Inclusion criteria: 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 criteria: 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.

      SAMPLE SIZE: Calculation of sample size: predictive modeling studies establish that it is
      necessary to have at least 10 events of the dependent variable of interest (readmissions) for
      each independent variable included in the multivariate model. In the multivariate logistic
      regression models, for the assessment of not less than 5 but not more than 10 variables, the
      investigators estimate that it will be necessary at least 100 events of the dependent
      variable (Readmissions) in the sample from which the investigators will derive the prediction
      rule to ensure that the model converges properly. With a 20% of readmissions, and requiring
      two samples (derivation and validation) the investigators need at least 1000 valid
      admissions. On the other hand, in the nested case-control study, to detect differences in the
      continuity of care at follow-up, from 70 to 55%, or in conciliation with medication from 30
      to 15%, separately for case (readmissions) and control groups, less than 200 valid patients
      would be needed for the analysis in each group (for and α=0.05 and a power (1-β) of 0.80),
      which suppose 1000 index admissions. To do this, each center will have to collect
      approximately 100-250 patients during the recruitment period. This is assured, while assuming
      a 20% of exclusions, including those cases that are programmed admissions, and 15% of losses
      on the remaining sample. Sampling: consecutive, all patients who re-enter and renter during
      the study period.

      METHODS: Variables to be included in the study: Variables to be collected from the Emergency
      Department: 1) level of awareness measured by Glasgow scale, baseline and admission dyspnea
      (MRC dyspnea and Borg fatigue scales), respiratory and cardiac frequency, blood pressure,
      fever, thoracic pain, gasometric parameters (arterial oxygen (PO2) or oxygen saturation
      (spoO2), pH, arterial carbon dioxide level (PCO2)); Variables to be collected during
      admission: 2) Background and sociodemographic (age, sex); health habits (smoking, exercise
      level), hearing or visual deficits, or falls; social support; 3) baseline COPD severity
      (measured by FEV1, 5), emergency visits in the last month and year, and previous admissions
      during the last 12 months; 4) Associated diseases that affect the exacerbation of COPD
      (cardiac, diabetes), and all those that the Charlson Comorbidity index; 5)Weight, height
      (BMI); 6)electrocardiography data, radiological findings, biochemical data and hematocrit,
      gasometry, FIO2 on arrival and discharge; 7) Other: basal treatment in the Emergency
      Department, and in the admission (short and/or long-term beta inhalers, anticholinergics,
      inhaled and/or oral orticoid, oxygen therapy), antibiotics, and other medications necessary
      for comorbidities; ICU admission, invasive mechanical ventilation; 8) presence of
      complications, or death; Variables to be collected at admission and until discharge: ECG,
      radiography at discharge, physiological data (temperature, respiratory and cardiac frequency,
      blood preassure), biochemical data and hematocrit, gasometry and/or pulsimetry. Length of
      hospital stay. Non-invasive ventilation or oxygen therapy at home. Health care habits
      (tobacco, diet, exercise), specialist or family physician assessment, and, if available, a
      review of inhalers using technique.

      Self-administered questionnaires to be completed by the patient during admission

        -  Assessment of the quality of life. EuroQol-5d generic questionnaire; specific
           questionnaire: COPD Assessment test (CAT).

        -  Symptoms´ assessment: MRC Dyspnea Scales; Physical Activity Questionnaire made ad hoc.

        -  Anxiety/depression assessment: HAD questionnaire.

        -  Social dependency: -Duke-UNC Social Support Scale

        -  Fragility assessment: Tilburg Frailty Indicator Part B (Components of frailty)

        -  Activities of daily living: Barthel's test. Variables to be collected from 2 months and
           until one year of follow-up: through the participants hospitals' computer systems
           (electronic medical history) and/or medical record on paper, and of the national death
           index it will be collected basic information of the new readmissions (cause, date,
           duration and complications) or patient's death.

      DATA COLLECTED. A) Patients recruitment: trained personnel, with help/supervision of the
      hospitals' respiratory specialist, will consecutively and prospectively recruit patients at
      each center that meet the inclusion criteria. For each patient, the data collector will be
      introduced to each patient to inform about the study aims', and if the patient agree to
      participate, and sign the inform consent, HRQoL questionnaires will be given. The
      questionnaires should be completed by the patient itself or with the help of a family member
      or caregiver. The data collector will establish when to get back the questionnaires. If the
      patients have been discharged, the questionnaires will be mailed. B) Clinical data
      collection: Information will be collected from the Emergency Department and later, from the
      medical record during admission and up to discharge. C) Identification of readmissions in the
      first two months: The same data collector described above will examine the readmission from
      the discharge to 60 days from it, to detect patients who are re-admitted. This will be
      identified as readmission, and simultaneously, a patient that will be act as control and who
      has been admitted at the same week as the patient with the current readmission will be
      searched, trying to match both patients by age (by categories of five years) and baseline
      FEV1 (greater or less than 50). All patients who have been readmitted within two months, and
      their established controls, will be immediately mailed the follow-up questionnaire (the
      corresponding questionnaire according if is case-readmission- or control situation). They
      will be phoned in advance to advise them of the mailing of the questionnaires. The
      questionnaires will be hand-delivered in the case of the patient hospital admitted at that
      time. If within 7/10 days the questionnaire has not been received, a reminder letter will be
      sent, and if in another 7/10 days the questionnaire has not been yet received, a letter with
      the questionnaire will it be sent again. D) One year follow-up: Of all the patients recruited
      in the index admission, whether they were readmissions, controls or not, clinical data will
      be completed up to the year. E) Blood sample: In three of the hospital participant a sample
      of blood has been collected in each index admission and stored in each Biobank. 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.
observational model: Cohort
time perspective: Prospective
measure: Readmission
time frame: 60 days from index admission
description: Hospital readmission
measure: Changes in HRQoL parameters
time frame: Index admission to 60 days
description: Changes from baseline-index admission- to 60 days in the scores of the different HRQoL questionnaires used
measure: Readmissions
time frame: One year from index admission
description: Hospital readmissions
measure: Mortality
time frame: One year from index admission
description: Death, by any cause or by respiratory cause
arm group label: COPD exacerbated patients admitted
description: No specific intervention
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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose M Quintana, MD, PhD
role: Principal Investigator
affiliation: Chief of Research Unit
facility: 
facility: 
facility: 
facility: 
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country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Galdakao-Usansolo
investigator full name: JOSE M QUINTANA-LOPEZ, MD PhD
investigator title: Chief of Research Unit
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Yes
ipd description: Data base will be allocated in a public server once main analysis have been done
ipd time frame: After all analysis related to the goals of the study have been performed and published
ipd access criteria: Based on our institution criteria