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Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study

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ClinicalTrials.gov Identifier: NCT03271593
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Gastroenteritis Other: No intervention

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : September 23, 2016
Actual Study Completion Date : September 23, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All children admitted
All children admitted to hospital
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Change in bed day occupancy (BDO) rates [ Time Frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015) ]
    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

  2. Change in turnover (TO) rates [ Time Frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015) ]
    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

  3. Change in early unplanned readmission (UR) rates [ Time Frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015) ]
    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

  4. Change in rate of nosocomial infections (NOSO) [ Time Frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015) ]
    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

  5. 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) ]
    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

  6. Change in number of positive test results [ Time Frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015) ]
    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

  7. 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) ]
    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


Secondary Outcome Measures :
  1. Development of a Quality of Care (QoC) score [ Time Frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children <15 years admitted to Alder Hey Children's NHS Foundation Trust. Four sub-populations: All admissions for any cause; Admission for an infectious disease; Admission for all cause gastroenteritis; Admission for Rotavirus gastroenteritis
Criteria

Inclusion Criteria:

  • All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271593


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Results disclosed in the Clinical Study Report.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03271593     History of Changes
Other Study ID Numbers: 205369
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs