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

NCT01592838 | Completed

• 1 other identifier: 116721
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infections, Rotavirus

Keywords

Belgium; Quality of hospital care; Rotavirus vaccination

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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)

• 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)

• 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)

Study Arms (1)

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

Interventions

Data collection OTHER

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.

Hospitalized Group

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: December 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 1, 2015

Record last verified: 2015-03