Last updated: 11/03/2018 19:29:44
Impact on quality of hospital care during pre- and post- rotavirus (RV) vaccination introduction in Belgium
GSK study ID
116721
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Feasibility pilot study assessing the impact on the quality of hospital care after the introduction of rotavirus vaccination in Belgium
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Determination of changes in hospitalisation pattern and workforce availability at the level of a pediatric ward in a hospital setting.
Timeframe: During the study period (from June 1st 2004 up to 6 years)
Secondary outcomes:
Expression of the changes into a quality of hospital care score that can be easily applied in different hospital settings.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: During the study period (from June 1st 2004 up to 6 years)
Interventions:
Other: Data collection
Enrollment:
1
Observational study model:
Ecologic or Community
Primary completion date:
2014-30-09
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
December 2013 to October 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 15 years
Accepts healthy volunteers
No
- All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period
- Not Applicable
Inclusion and exclusion 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:
- Not Applicable
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2014-30-09
Actual study completion date
2014-31-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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