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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Josien Riphagen-Dalhuisen, University Medical Centre Groningen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01481467
First Posted: November 29, 2011
Last Update Posted: December 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Josien Riphagen-Dalhuisen, University Medical Centre Groningen
  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
Intervention Model: Parallel Assignment
Masking: None (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 Josien Riphagen-Dalhuisen, University Medical Centre Groningen:

Primary Outcome Measures:
  • Influenza vaccine uptake among health care workers in the UMCs [ Time Frame: Up to 2 months ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Groningen Completed
Groningen, Netherlands, 9700 RB
University Medical Centre Recruiting
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center 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:
Hopman CE, Riphagen-Dalhuisen J, Looijmans-van den Akker I, Frijstein G, Van der Geest-Blankert AD, Danhof-Pont MB, De Jager HJ, Bos AA, Smeets E, De Vries MJ, Gallee PM, Lenderink AF, Hak E. Determination of factors required to increase uptake of influenza vaccination among hospital-based healthcare workers. J Hosp Infect. 2011 Apr;77(4):327-31. doi: 10.1016/j.jhin.2010.10.009. Epub 2011 Feb 12.
Osterholm MT, Kelley NS, Sommer A, Belongia EA. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2012 Jan;12(1):36-44. doi: 10.1016/S1473-3099(11)70295-X. Epub 2011 Oct 25. Review. Erratum in: Lancet Infect Dis. 2012 Sep;12(9):655.
Hayward AC, Watson J. Effectiveness of influenza vaccination of staff on morbidity, and mortality of residents of long term care facilities for the elderly. Vaccine. 2011 Mar 16;29(13):2357-8. doi: 10.1016/j.vaccine.2011.01.020. Epub 2011 Feb 2.
Potter J, Stott DJ, Roberts MA, Elder AG, O'Donnell B, Knight PV, Carman WF. Influenza vaccination of health care workers in long-term-care hospitals reduces the mortality of elderly patients. J Infect Dis. 1997 Jan;175(1):1-6.
Wilde JA, McMillan JA, Serwint J, Butta J, O'Riordan MA, Steinhoff MC. Effectiveness of influenza vaccine in health care professionals: a randomized trial. JAMA. 1999 Mar 10;281(10):908-13.
Carman WF, Elder AG, Wallace LA, McAulay K, Walker A, Murray GD, Stott DJ. Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial. Lancet. 2000 Jan 8;355(9198):93-7.
Saxén H, Virtanen M. Randomized, placebo-controlled double blind study on the efficacy of influenza immunization on absenteeism of health care workers. Pediatr Infect Dis J. 1999 Sep;18(9):779-83.
Weingarten S, Riedinger M, Bolton LB, Miles P, Ault M. Barriers to influenza vaccine acceptance. A survey of physicians and nurses. Am J Infect Control. 1989 Aug;17(4):202-7.
Christini AB, Shutt KA, Byers KE. Influenza vaccination rates and motivators among healthcare worker groups. Infect Control Hosp Epidemiol. 2007 Feb;28(2):171-7. Epub 2007 Jan 17.
Doebbeling BN, Edmond MB, Davis CS, Woodin JR, Zeitler RR. Influenza vaccination of health care workers: evaluation of factors that are important in acceptance. Prev Med. 1997 Jan-Feb;26(1):68-77.
Smedley J, Palmer C, Baird J, Barker M. A survey of the delivery and uptake of influenza vaccine among health care workers. Occup Med (Lond). 2002 Aug;52(5):271-6.
Canning HS, Phillips J, Allsup S. Health care worker beliefs about influenza vaccine and reasons for non-vaccination--a cross-sectional survey. J Clin Nurs. 2005 Sep;14(8):922-5.
Douville LE, Myers A, Jackson MA, Lantos JD. Health care worker knowledge, attitudes, and beliefs regarding mandatory influenza vaccination. Arch Pediatr Adolesc Med. 2010 Jan;164(1):33-7. doi: 10.1001/archpediatrics.2009.252.
van den Dool C, Bonten MJ, Hak E, Heijne JC, Wallinga J. The effects of influenza vaccination of health care workers in nursing homes: insights from a mathematical model. PLoS Med. 2008 Oct 28;5(10):e200. doi: 10.1371/journal.pmed.0050200.
Blank PR, Schwenkglenks M, Szucs TD. Vaccination coverage rates in eleven European countries during two consecutive influenza seasons. J Infect. 2009 Jun;58(6):446-58. doi: 10.1016/j.jinf.2009.04.001. Epub 2009 Apr 17.
Looijmans-van den Akker I, van Delden JJ, Verheij TJ, van der Sande MA, van Essen GA, Riphagen-Dalhuisen J, Hulscher ME, Hak E. Effects of a multi-faceted program to increase influenza vaccine uptake among health care workers in nursing homes: A cluster randomised controlled trial. Vaccine. 2010 Jul 12;28(31):5086-92. doi: 10.1016/j.vaccine.2010.05.003. Epub 2010 May 23.

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
First Submitted: November 10, 2011
First Posted: November 29, 2011
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by Josien Riphagen-Dalhuisen, 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
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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