Influenza Clinical Trial
Official title:
Evaluation of a Multi-faceted Influenza Vaccination Implementation Strategy for Health Care Workers in Hospitals
Influenza is a serious disease which can cause severe illness and even death among patients.
Health care workers (HCWs) often get infected with influenza and up to 76% of them keep
working while being ill. Immunizing HCWs is therefore an essential factor in protecting
patients from influenza as HCWs easily transmit influenza to their patients.
However, despite recommendations from the Dutch Health Council since 2007, vaccine uptake
among HCWs remains low.
The aim of this study is to develop an effective implementation strategy on the basis of
previous behavioural studies and to evaluate its value in a clustered randomized trial in
all Dutch University Medical Centers (UMCs). Also, we want to assess the program elements
that are associated with a higher vaccine uptake and the cost-effectiveness of such an
implementation strategy.
The results of this study will give more insights in the way influenza vaccination campaigns
should be directed in order to achieve high vaccine uptake rates among HCWs in hospitals.
Since influenza vaccination rates among hospital HCWs are low, we developed an
implementation program which will be tested in this large target group. The primary
objective is to evaluate the short- and long-term effects of a multi-faceted implementation
program to improve influenza vaccine uptake among HCWs in hospitals over two influenza
seasons. Its clinical effects are assessed by means of a randomized controlled trial in
selected divisions (e.g. internal medicine, pediatric ward) of all six randomized UMCs in
the Netherlands. Secondary aims are to assess program elements associated with higher
vaccine uptake among the target group and to evaluate the cost-effectiveness of the program.
The program will be developed using the Intervention Mapping method taking into account all
evidence from systematic literature review and the questionnaire study among HCWs in UMCs as
part of our before measurement (2008). The Intervention Mapping method is a theoretical
framework developed in the field of health education and promotion to systematically design
theory and evidence based health promotion programs.
In 2008, we have selected five divisions of all UMCs that will take part in the trial.
Before measurement showed wide variation of uptake (<15-50%) and 11 determinants that
explained more than 95% of the vaccination behaviour. Three UMCs will adopt the intervention
developed by the research group using the Intervention Mapping method, and three UMCs will
serve as controls. The current implemented programs in the UMCs vary widely ranging from
passive information systems to involvement of the Board of Directors. Our intervention will
exist of a multi-faceted program aimed at both HCWs and management of the divisions. Our
primary outcome will be the recorded vaccine uptake among HCWs in the UMCs.
To evaluate the short-term and long-term process of the program, web-based questionnaires
will be developed and directed at all health care workers of the selected divisions in all
UMCs. The questionnaire will contain questions about vaccine uptake and HCWs' opinions on
influenza, vaccination and the vaccination campaign. Absenteeism will also be registered.
Finally, patient data will be collected in the participating divisions of all UMCs in order
to investigate if there is a relationship between vaccinating HCWs and morbidity and
mortality in patients because of influenza.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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