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

March 30, 2015 updated by: GlaxoSmithKline

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children ≤15 years old hospitalised for any reason between June 2004 and May 2010.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospitalized Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
During the study period (from June 1st 2004 up to 6 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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.
Time Frame: During the study period (from June 1st 2004 up to 6 years)
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.
Time Frame: During the study period (from June 1st 2004 up to 6 years)
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.
Time Frame: During the study period (from June 1st 2004 up to 6 years)
During the study period (from June 1st 2004 up to 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 3, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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