<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/NCT03271593</url>
  </required_header>
  <id_info>
    <org_study_id>205369</org_study_id>
    <nct_id>NCT03271593</nct_id>
  </id_info>
  <brief_title>Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study</brief_title>
  <official_title>Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The impact of rotavirus vaccination on the burden of disease has been well documented.&#xD;
      However, the anticipated reduction in hospital pressures has yet to be described. This study&#xD;
      will provide quantitative measures of hospital pressure prior to and post vaccine&#xD;
      introduction, provide a template for future hospital pressures studies related to vaccine&#xD;
      introduction and provide measures which could be used in an economic evaluation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2015</start_date>
  <completion_date type="Actual">September 23, 2016</completion_date>
  <primary_completion_date type="Actual">September 23, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bed day occupancy (BDO) rates</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>BDO rate is measured as the number of bed days occupied divided by the total number of bed days available in a ward during a fixed time period. BDO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in turnover (TO) rates</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>TO rate is the change in average hospital duration measured as average number of days stay per admission. TO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in early unplanned readmission (UR) rates</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>UR rate (within 7 days after discharge) is measured as the number of readmissions ≤7 days after discharge (x100) divided by the total number of discharges. UR rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in rate of nosocomial infections (NOSO)</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>NOSO rate is measured as positive test from a test taken &gt;2 days after admission. NOSO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of rotavirus gastroenteritis (RVAG) tests taken</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>RVAG rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of positive test results</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>Number of positive RVAG test results will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in rate of hospitalization in children less that 5 years old</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>Change in rate of hospitalization (in children less that 5 years old) will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of a Quality of Care (QoC) score</measure>
    <time_frame>During the study observation period of 15 years (1st July 2000 - 30th June 2015)</time_frame>
    <description>To develop the QoC score, a baseline rate/score for each outcome measure out-of-season (June-December) will be developed pre-vaccine introduction (vaccine introduction: 30th July 2013). Each outcome measure in the pre-vaccine period and post-vaccine period in-peak-season (January to May) will be scaled against that score. An overall QoC-Score pre- and post-vaccine in peak season will be calculated by summing scores for each outcome measure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Gastroenteritis</condition>
  <arm_group>
    <arm_group_label>All children admitted</arm_group_label>
    <description>All children admitted to hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>All children admitted</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children &lt;15 years admitted to Alder Hey Children's NHS Foundation Trust. Four&#xD;
        sub-populations: All admissions for any cause; Admission for an infectious disease;&#xD;
        Admission for all cause gastroenteritis; Admission for Rotavirus gastroenteritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for&#xD;
             whatever reason during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 5, 2016</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03271593
org study id: 205369
nct id: NCT03271593
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The impact of rotavirus vaccination on the burden of disease has been well documented.
      However, the anticipated reduction in hospital pressures has yet to be described. This study
      will provide quantitative measures of hospital pressure prior to and post vaccine
      introduction, provide a template for future hospital pressures studies related to vaccine
      introduction and provide measures which could be used in an economic evaluation.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Change in bed day occupancy (BDO) rates
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: BDO rate is measured as the number of bed days occupied divided by the total number of bed days available in a ward during a fixed time period. BDO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
measure: Change in turnover (TO) rates
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: TO rate is the change in average hospital duration measured as average number of days stay per admission. TO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
measure: Change in early unplanned readmission (UR) rates
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: UR rate (within 7 days after discharge) is measured as the number of readmissions ≤7 days after discharge (x100) divided by the total number of discharges. UR rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
measure: Change in rate of nosocomial infections (NOSO)
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: NOSO rate is measured as positive test from a test taken >2 days after admission. NOSO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
measure: Change in number of rotavirus gastroenteritis (RVAG) tests taken
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: RVAG rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
measure: Change in number of positive test results
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: Number of positive RVAG test results will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
measure: Change in rate of hospitalization in children less that 5 years old
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: Change in rate of hospitalization (in children less that 5 years old) will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
measure: Development of a Quality of Care (QoC) score
time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
description: To develop the QoC score, a baseline rate/score for each outcome measure out-of-season (June-December) will be developed pre-vaccine introduction (vaccine introduction: 30th July 2013). Each outcome measure in the pre-vaccine period and post-vaccine period in-peak-season (January to May) will be scaled against that score. An overall QoC-Score pre- and post-vaccine in peak season will be calculated by summing scores for each outcome measure
arm group label: All children admitted
description: All children admitted to hospital
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: All children admitted
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
responsible party type: Sponsor
mesh term: Gastroenteritis