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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01592838
First received: May 3, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention
Infections, Rotavirus
Other: Data collection

Study Type: Observational
Study Design: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592838

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592838     History of Changes
Other Study ID Numbers: 116721
Study First Received: May 3, 2012
Last Updated: June 5, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by GlaxoSmithKline:
Rotavirus vaccination
Belgium
Quality of hospital care

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014