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

Infections, Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592838
• Other study ID #: 116721
• Status: Completed
• Phase: N/A
• First received: May 3, 2012
• Last updated: March 30, 2015
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No