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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03271593
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date August 5, 2016
First Posted Date September 5, 2017
Last Update Posted Date September 21, 2017
Actual Study Start Date November 2, 2015
Actual Primary Completion Date September 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03271593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 1, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Gastroenteritis
Intervention Other: No intervention
No intervention
Study Groups/Cohorts All children admitted
All children admitted to hospital
Intervention: Other: No intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2017)
1
Original Actual Enrollment Same as current
Actual Study Completion Date September 23, 2016
Actual Primary Completion Date September 23, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03271593
Other Study ID Numbers 205369
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2017