Evaluation of an Influenza Vaccination Implementation Strategy for Hospital Health Care Workers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University Medical Centre Groningen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Josien Riphagen-Dalhuisen, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01481467
First received: November 10, 2011
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Influenza
Behavioral: Influenza vaccination implementation strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of a Multi-faceted Influenza Vaccination Implementation Strategy for Health Care Workers in Hospitals

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Influenza vaccine uptake among health care workers in the UMCs [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    Influenza vaccine uptake among health care workers of all UMCs. Measured by means of data provided by the departments of occupational health. For the assessment of short-term effects vaccine uptake is measured after the first influenza season (2009/2010) in February-March 2010 and for the long-term effects it is measured after the second influenza season (2010/2011) in March-April 2011.


Secondary Outcome Measures:
  • Absenteeism among health care workers during influenza epidemics [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
    Absenteeism among HCWs is assessed by means of data provided by the department of occupational health at the end of both influenza seasons.

  • Patient morbidity and mortality [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
    After the second influenza season (2010/2011) patient data are collected from selected departments of both the intervention and control UMCs. It is measured by assessing if patients had influenza, if they were tested on influenza, if they had developed a pneumonia, if they were admissioned to the intensive care unit, the duration of hospitalization and intensive care admission and finally mortality.


Estimated Enrollment: 6
Study Start Date: April 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Influenza vaccination implementation strategy applied.
Behavioral: Influenza vaccination implementation strategy
A multi-faceted influenza vaccination implementation strategy
No Intervention: Control
Usual care.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for clusters:

  • University Medical Hospital in the Netherlands

Exclusion Criteria for clusters:

  • Absence of consent to be randomized

Inclusion Criteria for participants:

  • Health care staff at University Medical Hospitals
  • Patients cared for during the study influenza epidemics of selected divisions

Exclusion Criteria for participants:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481467

Contacts
Contact: Josien Riphagen-Dalhuisen, MD +31 (0)6 45 23 80 26 j.riphagen@umcg.nl
Contact: Eelko Hak, PhD +31 (0)50 363 7576 e.hak@rug.nl

Locations
Netherlands
University Medical Centre Recruiting
Groningen, Netherlands, 9700 RB
University Medical Centre Groningen Completed
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Centre Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Josien Riphagen-Dalhuisen, MD University Medical Centre Groningen/ University of Groningen
Study Director: Eelko Hak, PhD University Medical Centre Groninge/University of Groningen
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josien Riphagen-Dalhuisen, MD, PhD fellow, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01481467     History of Changes
Other Study ID Numbers: 125030012
Study First Received: November 10, 2011
Last Updated: December 19, 2011
Health Authority: The Netherlands: The Netherlands Organisation for Health Research and Development

Keywords provided by University Medical Centre Groningen:
influenza vaccination
intervention mapping
hospital care
respiratory infections
vaccination

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014