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

Completed

• Conditions: Infections, Rotavirus
• Interventions: Other: Data collection

• Registration Number: NCT01592838
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Study Start: 2013-12
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized Group	Data collection	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.

Primary Outcome Measures

Name	Time	Method
Determination of changes in hospitalisation pattern and workforce availability at the level of a pediatric ward in a hospital setting.	During the study period (from June 1st 2004 up to 6 years)

Secondary Outcome Measures

Name	Time	Method
Determination through factor and regression analysis which variable influences most the score in order to improve the score calculation.	During the study period (from June 1st 2004 up to 6 years)
Expression of the changes into a quality of hospital care score that can be easily applied in different hospital settings.	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.	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.	During the study period (from June 1st 2004 up to 6 years)