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Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium

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ClinicalTrials.gov Identifier: NCT01592838
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

May 3, 2012
May 7, 2012
April 1, 2015
December 2013
September 2014   (Final data collection date for primary outcome measure)
Determination of changes in hospitalisation pattern and workforce availability at the level of a pediatric ward in a hospital setting. [ Time Frame: During the study period (from June 1st 2004 up to 6 years) ]
Same as current
Complete list of historical versions of study NCT01592838 on ClinicalTrials.gov Archive Site
  • Expression of the changes into a quality of hospital care score that can be easily applied in different hospital settings. [ Time Frame: During the study period (from June 1st 2004 up to 6 years) ]
  • Determination through factor and regression analysis which variable influences most the score in order to improve the score calculation. [ Time Frame: During the study period (from June 1st 2004 up to 6 years) ]
  • Investigation of whether a change in the quality of hospital care score could be linked to the introduction of rotavirus vaccination. [ Time Frame: During the study period (from June 1st 2004 up to 6 years) ]
  • Observation of other changes in the hospital organisation as a consequence of a change in the quality of hospital care score. [ Time Frame: During the study period (from June 1st 2004 up to 6 years) ]
Same as current
Not Provided
Not Provided
 
Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium
Feasibility Pilot Study Assessing the Impact on the Quality of Hospital Care After the Introduction of Rotavirus Vaccination in Belgium
This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in paediatric wards over the last 6 years (during a whole year or during specific time periods of the year) and if changes of any of the variables measured during the observation period could be linked to the introduction of rotavirus vaccination.
This retrospective study will use data extracted from hospital databases during the period of the 1st of June 2004 until the 31st of May 2010. A coded list of all hospitalisations and of the different infection tests performed in children will be generated, together with a list of Full time equivalents (FTE) in paediatric ward and the number of sick leave days of the working personnel.
Observational
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample
Children ≤15 years old hospitalised for any reason between June 2004 and May 2010.
Infections, Rotavirus
Other: Data collection
The participating centre will be requested to generate a coded list of all hospitalisations taken place during the study period (June 1st 2004- May 31st 2010) and analysed for changes in hospital pattern pre- versus post-rotavirus vaccination, in children aged ≤15 years.
Hospitalized Group
Data collection for changes in hospital pattern pre- versus post-rotavirus vaccination, in children ≤15 years old hospitalised for any reason between June 2004 and May 2010.
Intervention: Other: Data collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
Same as current
October 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Sexes Eligible for Study: All
up to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01592838
116721
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2015