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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01592838
Collaborator
(none)
1
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data collection

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 Design

Study Type:
Observational
Actual Enrollment :
1 participants
Observational Model:
Ecologic or Community
Time Perspective:
Retrospective
Official Title:
Feasibility Pilot Study Assessing the Impact on the Quality of Hospital Care After the Introduction of Rotavirus Vaccination in Belgium
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)]

  2. 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)]

  3. 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)]

  4. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01592838
Other Study ID Numbers:
  • 116721
First Posted:
May 7, 2012
Last Update Posted:
Apr 1, 2015
Last Verified:
Mar 1, 2015
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2015