Skip to main content
OpenTrials
Completed

NCT Number: NCT03271593

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroenteritis Digestive System Diseases Gastrointestinal Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2017
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.