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
NCT01592838
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2014-30-09
    Observational study model:
    Ecologic or Community
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    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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