Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium
This study is not yet open for participant recruitment.
Verified February 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01592838
First received: May 3, 2012
Last updated: February 7, 2013
Last verified: February 2013
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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 |
|---|---|
|
Gastroenteritis |
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 |
Resource links provided by NLM:
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: | June 2013 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592838
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
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: | February 7, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products |
Keywords provided by GlaxoSmithKline:
|
Rotavirus vaccination Belgium Quality of hospital care |
Additional relevant MeSH terms:
|
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013