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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271593
• Other study ID #: 205369
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: September 20, 2017
• Start date: November 2, 2015
• Est. completion date: September 23, 2016

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 23, 2016
• Est. primary completion date: September 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bed day occupancy (BDO) rates	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Primary	Change in turnover (TO) rates	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Primary	Change in early unplanned readmission (UR) rates	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Primary	Change in rate of nosocomial infections (NOSO)	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Primary	Change in number of rotavirus gastroenteritis (RVAG) tests taken	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Primary	Change in number of positive test results	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Primary	Change in rate of hospitalization in children less that 5 years old	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Secondary	Development of a Quality of Care (QoC) score	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	During the study observation period of 15 years (1st July 2000 - 30th June 2015)