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

NCT03271593 | Completed

• 1 other identifier: 205369
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Development of a Quality of Care (QoC) score

  During the study observation period of 15 years (1st July 2000 - 30th June 2015)

Study Arms (1)

All children admitted

All children admitted to hospital

Other: No intervention

Interventions

No intervention OTHER

No intervention

All children admitted

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 31097487 DERIVED

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: September 5, 2017
• Study Start: November 2, 2015
• Primary Completion: September 23, 2016
• Study Completion: September 23, 2016
• Last Updated: September 21, 2017

Record last verified: 2017-09