Clinical trial NCT03271593: Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study
Official title: Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-09-05
Enrollment: 1
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Change in bed day occupancy (BDO) rates
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
measure: Change in turnover (TO) rates
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
measure: Change in early unplanned readmission (UR) rates
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
measure: Change in rate of nosocomial infections (NOSO)
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
measure: Change in number of rotavirus gastroenteritis (RVAG) tests taken
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
measure: Change in number of positive test results
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
measure: Change in rate of hospitalization in children less that 5 years old
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Secondary outcomes:
measure: Development of a Quality of Care (QoC) score
timeFrame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Heinsbroek E, Hungerford D, Cooke RPD, Chowdhury M, Cargill JS, Bar-Zeev N, French N, Theodorou E, Standaert B, Cunliffe NA. Do hospital pressures change following rotavirus vaccine introduction? A retrospective database analysis in a large paediatric hospital in the UK. BMJ Open. 2019 May 15;9(5):e027739. doi: 10.1136/bmjopen-2018-027739.