<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/NCT04503434</url>
  </required_header>
  <id_info>
    <org_study_id>Medicalitzed Hotel COVID-19</org_study_id>
    <nct_id>NCT04503434</nct_id>
  </id_info>
  <brief_title>Patients' Experiences in a Medicalized Hotel for COVID-19 Acute Care Support</brief_title>
  <official_title>Patients' Experiences in a Medicalized Hotel for COVID-19 Acute Care Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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>
      The 11th March 2020, the World Health Organization (WHO) declared the novel coronavirus&#xD;
      Covid-19 as a pandemic. Urgent reorganization was required to give answers to the needs of&#xD;
      this new illness. Since mid March, the number of patients admitted every day grew&#xD;
      exponentially, and despite strengthening the Home Hospitalization service, resources were&#xD;
      insufficient to care for such a number of people at home. The HH was called to transform a&#xD;
      hotel into a medicalized healthcare space.&#xD;
&#xD;
      Current health policy emphasizes on patient experience, as one of the key components of&#xD;
      quality of care. Analyzing patients experience will provide knowledge about their authentic&#xD;
      concerns or what they identify as real needs, how they perceive the care received and will&#xD;
      allow finding out if it was a good alternative. Patients must be involved in decision-making&#xD;
      about their heath situation and treatment in order to provide an integrated healthcare.&#xD;
&#xD;
      Aims: To assess the patient experience during hospital admission in a Medicalized Hotel for&#xD;
      COVID-19, from 8th March to 25th May, and variables that may influence these experiences.&#xD;
&#xD;
      Study type: Observational and descriptive study with a cross-sectional design. The study&#xD;
      population consisted of patients admitted in Medicalized Hotel who met inclusion criteria.&#xD;
&#xD;
      Sample size: 517 patients. Main variable: Patient experience (collected by the Picker Patient&#xD;
      Experience questionnaire, PPE-15, translated to Catalan and Spanish), that content four open&#xD;
      questions analyzed in a qualitative way. Other variables: Socio-demographic and review&#xD;
      clinical records.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current pandemic caused by the rapid spread of severe acute respiratory syndrome&#xD;
      coronavirus 2 (SARS-CoV-2) demands urgent reorganization. Hospital multidisciplinary and&#xD;
      departmental collaboration was required to work on all the principles of overvoltage&#xD;
      capacity, including: new space definition; provision's resources; staff recruitment; and ad&#xD;
      hoc training. Likewise, assistant protocols suffered continuous modifications to deal with&#xD;
      this new situation.&#xD;
&#xD;
      Catalonia is one of the 17 autonomous communities of Spain and it has been granted global&#xD;
      competencies in the area of healthcare. The Catalan healthcare model is a multi-provider one&#xD;
      integrated in a unique public network. The organization is structured in four integrated&#xD;
      health areas, one of which is the Integrated Health Area of Barcelona Esquerra (Área Integral&#xD;
      de Salud de Barcelona Esquerra - AIS-BE), caring for a population of 524,000 inhabitants,&#xD;
      representing 35% of the population of Barcelona. The territory referred to this study,&#xD;
      includes the Hospital Clinic as reference center, two general hospitals and 19 primary care&#xD;
      centers. The Hospital Clínic -a tertiary university hospital- is a public institution with a&#xD;
      long reputation of excellence in care provision, training and research at national and&#xD;
      international level.&#xD;
&#xD;
      The management of the Hospital Clinic worked on a contingency plan, at internal and&#xD;
      territorial level, together with the Health Department of the Generalitat de Catalunya. For&#xD;
      the internal contingency plan to deal with the pandemic, different committees were created.&#xD;
      Two of them were the Technical /Operational Committee and the ICU Committee. The technical&#xD;
      committee included the Departments of Internal Medicine, Infections, Pneumology, Microbiology&#xD;
      and all the medical and surgical departments with ICUs, occupational health, and the&#xD;
      transversal Home Hospitalization Unit (HH) to maximize cooperation among professionals,&#xD;
      levels of care and institutions. Hospital-at-home is defined as the service in charge of&#xD;
      providing active treatment by health care professionals, in patient's house, for a condition&#xD;
      that otherwise would require traditional hospitalization for a limited period of time (8).&#xD;
      Hospital-at-home is a safe and cost effectiveness service, and has become a popular response&#xD;
      to the increasing demand for acute hospital beds.&#xD;
&#xD;
      The idea of transforming a hotel into a healthcare facility wanted to solve three needs: a)&#xD;
      grouping patients who required HH, b) providing more beds (offering intermediate care to&#xD;
      patients who didn't require critical care) and c) allowing the isolation of people who cannot&#xD;
      do it at home.&#xD;
&#xD;
      This paper consists in an observational and descriptive study with a cross-sectional design,&#xD;
      in which we analyze patients' experience during admission in a Medicalized Hotel using a&#xD;
      validate survey.&#xD;
&#xD;
      The study population consisted of patients admitted in Medicalized Hotel led by Hospital&#xD;
      Clinic, Barcelona from 25th March to 8th May.&#xD;
&#xD;
      Inclusion criteria: All patients admitted in Medicalized Hospital who agreed to participate&#xD;
      in the study Exclusion criteria: non localized or localized but rejected to participate,&#xD;
      language barrier and dementia.&#xD;
&#xD;
      Data collection: The Picker Patient Experience Questionnaire validated into Spanish was used&#xD;
      to measure the patient experience. The PPE-15 was developed to elicit feedback from patients&#xD;
      to highlight aspects of care that needed improvement and to monitor performance and care.&#xD;
&#xD;
      Participants included in this analysis responded voluntarily to an online questionnaire&#xD;
      distributed by mail, focused on their experiences around Medicalized Hotel admissions and&#xD;
      transitional care strategies after 1 month of discharge. The questionnaire was carried out by&#xD;
      telephone to the patients who did not have email address. The investigators, reported if the&#xD;
      questionnaire was self-administered or by phone. The investigators used the platform&#xD;
      &quot;enquesta.clinic.cat&quot; that guarantees confidentiality and security and no identification&#xD;
      details were collected.&#xD;
&#xD;
      Other variables collected: Socio-demographic data, such as gender, age, nationality, civil&#xD;
      status (married, single, widow/widower, in a relationship), housing status (living alone or&#xD;
      not), educational level (compulsory school, upper secondary school or university), and&#xD;
      employment status (still working or not), and review clinical records, like length of&#xD;
      Medicalized Hotel stay (days of admission), inpatient's unit (those who had been in a ICU),&#xD;
      patients discharge destination and comorbidities (Charlson Comorbidity Index). The data&#xD;
      collected from the medical history database were encrypted and stored in an internal and&#xD;
      safety server.&#xD;
&#xD;
      All participants were informed in advance about the aim of the study. They received all&#xD;
      recommendations given by legal services of the Hospital Clinic and were invited to&#xD;
      participate. The confirmation of the study participation, as well as allowing the researchers&#xD;
      to use the information collected from medical history, will be made by clicking the link to&#xD;
      access into the questionnaire. This study was approved by the Ethics and Investigation&#xD;
      Committee of the Hospital Clinic (CEIm).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">June 6, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>The Picker Patient Experience Questionnaire</measure>
    <time_frame>one month</time_frame>
    <description>An adapted shorter version of The Picker Patient Experience Questionnaire, validated into Spanish and Catalan was used to identify whether exist any problem in the healthcare provided. It consists of 15 questions distributed to eight dimensions of care: respect, coordination, information/communication/education, physical comfort, emotional support, involvement of relatives, transition and continuity and finally overall impression.&#xD;
The questions have from two (&quot;yes&quot; or &quot;no&quot;) responses to four answer options (&quot;yes&quot;, &quot;yes, to some extend&quot;, &quot;no&quot; or &quot;I didn't need to&quot;). Neutral answers, such as &quot;I did not need to&quot;, and the most positive answer are coded as a &quot;non-problem&quot; (score = 0). The remaining responses are coded as &quot;problems&quot; (score = 1). The PPE-15 has previously been found to be valid and reliable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Open questions</measure>
    <time_frame>one month</time_frame>
    <description>Four open questions were included in the questionnaire, which enclosed what worried the participants the most, which aspects did they like and which ones they dislike about the medicalized hotel and what will they improve. Those were analysed in a qualitative technique, using the MAXQDA program. This informatics program led importing, transcribing and analysing the information obtained, by keeping the most relevant data and categorising it after having done a correct codification. All the information obtained will rest anonymous.</description>
  </secondary_outcome>
  <enrollment type="Actual">517</enrollment>
  <condition>Patient Preference</condition>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        517 patients admitted to Medicalitzed Hotel with confirmed SARS-CoV2 infection from March&#xD;
        25th to May 8th&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted in Medicalized Hospital who agreed to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not localized, language barrier, dementia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Carme Hernandez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carme Hernández</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.</citation>
    <PMID>31978945</PMID>
  </results_reference>
  <results_reference>
    <citation>Hernandez C, Aibar J, Seijas N, Puig I, Alonso A, Garcia-Aymerich J, Roca J. Implementation of Home Hospitalization and Early Discharge as an Integrated Care Service: A Ten Years Pragmatic Assessment. Int J Integr Care. 2018 May 16;18(2):12. doi: 10.5334/ijic.3431.</citation>
    <PMID>30127696</PMID>
  </results_reference>
  <results_reference>
    <citation>Bertran MJ, Vinaras M, Salamero M, Garcia F, Graham C, McCulloch A, Escarrabill J. Spanish and Catalan translation, cultural adaptation and validation of the Picker Patient Experience Questionnaire-15. J Healthc Qual Res. 2018 Jan-Feb;33(1):10-17. doi: 10.1016/j.cali.2017.12.004. Epub 2018 Feb 14.</citation>
    <PMID>29454739</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Carme Hernandez</investigator_full_name>
    <investigator_title>Director of Home Hospitalization unit and Coordinator of Medicalitzed-Hotel</investigator_title>
  </responsible_party>
  <keyword>Hospital Hotel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://enquesta.clinic.cat/index.php/admin/survey/sa/view/surveyid/818692</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04503434
org study id: Medicalitzed Hotel COVID-19
nct id: NCT04503434
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The 11th March 2020, the World Health Organization (WHO) declared the novel coronavirus
      Covid-19 as a pandemic. Urgent reorganization was required to give answers to the needs of
      this new illness. Since mid March, the number of patients admitted every day grew
      exponentially, and despite strengthening the Home Hospitalization service, resources were
      insufficient to care for such a number of people at home. The HH was called to transform a
      hotel into a medicalized healthcare space.

      Current health policy emphasizes on patient experience, as one of the key components of
      quality of care. Analyzing patients experience will provide knowledge about their authentic
      concerns or what they identify as real needs, how they perceive the care received and will
      allow finding out if it was a good alternative. Patients must be involved in decision-making
      about their heath situation and treatment in order to provide an integrated healthcare.

      Aims: To assess the patient experience during hospital admission in a Medicalized Hotel for
      COVID-19, from 8th March to 25th May, and variables that may influence these experiences.

      Study type: Observational and descriptive study with a cross-sectional design. The study
      population consisted of patients admitted in Medicalized Hotel who met inclusion criteria.

      Sample size: 517 patients. Main variable: Patient experience (collected by the Picker Patient
      Experience questionnaire, PPE-15, translated to Catalan and Spanish), that content four open
      questions analyzed in a qualitative way. Other variables: Socio-demographic and review
      clinical records.
The current pandemic caused by the rapid spread of severe acute respiratory syndrome
      coronavirus 2 (SARS-CoV-2) demands urgent reorganization. Hospital multidisciplinary and
      departmental collaboration was required to work on all the principles of overvoltage
      capacity, including: new space definition; provision's resources; staff recruitment; and ad
      hoc training. Likewise, assistant protocols suffered continuous modifications to deal with
      this new situation.

      Catalonia is one of the 17 autonomous communities of Spain and it has been granted global
      competencies in the area of healthcare. The Catalan healthcare model is a multi-provider one
      integrated in a unique public network. The organization is structured in four integrated
      health areas, one of which is the Integrated Health Area of Barcelona Esquerra (Área Integral
      de Salud de Barcelona Esquerra - AIS-BE), caring for a population of 524,000 inhabitants,
      representing 35% of the population of Barcelona. The territory referred to this study,
      includes the Hospital Clinic as reference center, two general hospitals and 19 primary care
      centers. The Hospital Clínic -a tertiary university hospital- is a public institution with a
      long reputation of excellence in care provision, training and research at national and
      international level.

      The management of the Hospital Clinic worked on a contingency plan, at internal and
      territorial level, together with the Health Department of the Generalitat de Catalunya. For
      the internal contingency plan to deal with the pandemic, different committees were created.
      Two of them were the Technical /Operational Committee and the ICU Committee. The technical
      committee included the Departments of Internal Medicine, Infections, Pneumology, Microbiology
      and all the medical and surgical departments with ICUs, occupational health, and the
      transversal Home Hospitalization Unit (HH) to maximize cooperation among professionals,
      levels of care and institutions. Hospital-at-home is defined as the service in charge of
      providing active treatment by health care professionals, in patient's house, for a condition
      that otherwise would require traditional hospitalization for a limited period of time (8).
      Hospital-at-home is a safe and cost effectiveness service, and has become a popular response
      to the increasing demand for acute hospital beds.

      The idea of transforming a hotel into a healthcare facility wanted to solve three needs: a)
      grouping patients who required HH, b) providing more beds (offering intermediate care to
      patients who didn't require critical care) and c) allowing the isolation of people who cannot
      do it at home.

      This paper consists in an observational and descriptive study with a cross-sectional design,
      in which we analyze patients' experience during admission in a Medicalized Hotel using a
      validate survey.

      The study population consisted of patients admitted in Medicalized Hotel led by Hospital
      Clinic, Barcelona from 25th March to 8th May.

      Inclusion criteria: All patients admitted in Medicalized Hospital who agreed to participate
      in the study Exclusion criteria: non localized or localized but rejected to participate,
      language barrier and dementia.

      Data collection: The Picker Patient Experience Questionnaire validated into Spanish was used
      to measure the patient experience. The PPE-15 was developed to elicit feedback from patients
      to highlight aspects of care that needed improvement and to monitor performance and care.

      Participants included in this analysis responded voluntarily to an online questionnaire
      distributed by mail, focused on their experiences around Medicalized Hotel admissions and
      transitional care strategies after 1 month of discharge. The questionnaire was carried out by
      telephone to the patients who did not have email address. The investigators, reported if the
      questionnaire was self-administered or by phone. The investigators used the platform
      "enquesta.clinic.cat" that guarantees confidentiality and security and no identification
      details were collected.

      Other variables collected: Socio-demographic data, such as gender, age, nationality, civil
      status (married, single, widow/widower, in a relationship), housing status (living alone or
      not), educational level (compulsory school, upper secondary school or university), and
      employment status (still working or not), and review clinical records, like length of
      Medicalized Hotel stay (days of admission), inpatient's unit (those who had been in a ICU),
      patients discharge destination and comorbidities (Charlson Comorbidity Index). The data
      collected from the medical history database were encrypted and stored in an internal and
      safety server.

      All participants were informed in advance about the aim of the study. They received all
      recommendations given by legal services of the Hospital Clinic and were invited to
      participate. The confirmation of the study participation, as well as allowing the researchers
      to use the information collected from medical history, will be made by clicking the link to
      access into the questionnaire. This study was approved by the Ethics and Investigation
      Committee of the Hospital Clinic (CEIm).
observational model: Cohort
time perspective: Cross-Sectional
measure: The Picker Patient Experience Questionnaire
time frame: one month
description: An adapted shorter version of The Picker Patient Experience Questionnaire, validated into Spanish and Catalan was used to identify whether exist any problem in the healthcare provided. It consists of 15 questions distributed to eight dimensions of care: respect, coordination, information/communication/education, physical comfort, emotional support, involvement of relatives, transition and continuity and finally overall impression.
The questions have from two ("yes" or "no") responses to four answer options ("yes", "yes, to some extend", "no" or "I didn't need to"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1). The PPE-15 has previously been found to be valid and reliable.
measure: Open questions
time frame: one month
description: Four open questions were included in the questionnaire, which enclosed what worried the participants the most, which aspects did they like and which ones they dislike about the medicalized hotel and what will they improve. Those were analysed in a qualitative technique, using the MAXQDA program. This informatics program led importing, transcribing and analysing the information obtained, by keeping the most relevant data and categorising it after having done a correct codification. All the information obtained will rest anonymous.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Carme Hernandez, PhD
role: Principal Investigator
affiliation: Hospital Clinic
facility: 
country: Spain
citation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PMID: 31978945
citation: Hernandez C, Aibar J, Seijas N, Puig I, Alonso A, Garcia-Aymerich J, Roca J. Implementation of Home Hospitalization and Early Discharge as an Integrated Care Service: A Ten Years Pragmatic Assessment. Int J Integr Care. 2018 May 16;18(2):12. doi: 10.5334/ijic.3431.
PMID: 30127696
citation: Bertran MJ, Vinaras M, Salamero M, Garcia F, Graham C, McCulloch A, Escarrabill J. Spanish and Catalan translation, cultural adaptation and validation of the Picker Patient Experience Questionnaire-15. J Healthc Qual Res. 2018 Jan-Feb;33(1):10-17. doi: 10.1016/j.cali.2017.12.004. Epub 2018 Feb 14.
PMID: 29454739
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Carme Hernandez
investigator title: Director of Home Hospitalization unit and Coordinator of Medicalitzed-Hotel
mesh term: COVID-19
sharing ipd: No
study doc: 