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Completed

NCT Number: NCT01592838

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

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Feasibility Pilot Study Assessing the Impact on the Quality of Hospital Care After the Introduction of Rotavirus Vaccination in Belgium

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 7, 2012
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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