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

Completed

• Conditions: Gastroenteritis
• Interventions: Other: No intervention

• Registration Number: NCT03271593
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-11-02
• Study First Submitted: 2016-08-05
• Primary Completion: 2016-09-23
• Study Completion: 2016-09-23
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All children admitted	No intervention	All children admitted to hospital

Primary Outcome Measures

Name	Time	Method
Change in bed day occupancy (BDO) rates	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
Change in rate of nosocomial infections (NOSO)	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
Change in number of rotavirus gastroenteritis (RVAG) tests taken	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
Change in turnover (TO) rates	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
Change in early unplanned readmission (UR) rates	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
Change in number of positive test results	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
Change in rate of hospitalization in children less that 5 years old	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

Name	Time	Method
Development of a Quality of Care (QoC) score	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