InfluenzaNCT01481467
Evaluation of an Influenza Vaccination Implementation Strategy for Hospital Health Care Workers
A study testing Influenza vaccination implementation strategy in people with Influenza, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccination implementation strategy
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- University Medical Hospital in the Netherlands
- Health care staff at University Medical Hospitals
- Patients cared for during the study influenza epidemics of selected divisions
Who cannot join
- Absence of consent to be randomized
- None
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 1 recruiting
- Completed
University Medical Centre Groningen
Groningen, 9700 RB
- Recruiting
University Medical Centre
Groningen, 9700 RB
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Influenza vaccination implementation strategy
- Keywords
- influenza vaccination, intervention mapping, hospital care, respiratory infections, vaccination
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccination implementation strategyBehavioural
A multi-faceted influenza vaccination implementation strategy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Influenza vaccination implementation strategy applied. Receives: Behavioral: Influenza vaccination implementation strategy |
| Control | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccine uptake among health care workers in the UMCs
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.
Measured: Up to 2 months
Secondary outcomes (2)
Absenteeism among health care workers during influenza epidemics
Absenteeism among HCWs is assessed by means of data provided by the department of occupational health at the end of both influenza seasons.
Measured: Up to 5 months
Patient morbidity and mortality
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.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startApr 2009
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Josien Riphagen-Dalhuisen, University Medical Center Groningen
- Investigators
- Josien Riphagen-Dalhuisen, MD, Principal investigator, University Medical Centre Groningen/ University of GroningenEelko Hak, PhD, Study director, University Medical Centre Groninge/University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481467
- Sponsor's protocol ID
- 125030012
- Status last verified
- Dec 2011
- First submitted
- 10 Nov 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22032844Hayward 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. No abstract available.
PubMed 21295099Potter 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. doi: 10.1093/infdis/175.1.1.
PubMed 8985189Wilde 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. doi: 10.1001/jama.281.10.908.
PubMed 10078487Carman 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. doi: 10.1016/S0140-6736(99)05190-9.
PubMed 10675165Saxen 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. doi: 10.1097/00006454-199909000-00007.
PubMed 10493337Weingarten 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. doi: 10.1016/0196-6553(89)90129-6.
PubMed 2774292Christini AB, Shutt KA, Byers KE. Influenza vaccination rates and motivators among healthcare worker groups. Infect Control Hosp Epidemiol. 2007 Feb;28(2):171-7. doi: 10.1086/511796. Epub 2007 Jan 17.
PubMed 17265398Doebbeling 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. doi: 10.1006/pmed.1996.9991.
PubMed 9010900Smedley 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. doi: 10.1093/occmed/52.5.271.
PubMed 12181376Canning 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. doi: 10.1111/j.1365-2702.2005.01190.x.
PubMed 16102143Douville 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.
PubMed 20048239van 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.
PubMed 18959470Blank 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.
PubMed 19446340Looijmans-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.
PubMed 20580740
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multi-faceted Influenza Vaccination Implementation Strategy for Health Care Workers in Hospitals
- ClinicalTrials.gov ID
- NCT01481467
- Acronym / sponsor ID
- 125030012
- Conditions
- Influenza
- Keywords
- influenza vaccination, intervention mapping, hospital care, respiratory infections, vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Apr 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Influenza vaccination implementation strategyInfluenza vaccination implementation strategy applied. |
| Control | No intervention | –Usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- University Medical Hospital in the Netherlands
- Health care staff at University Medical Hospitals
- Patients cared for during the study influenza epidemics of selected divisions
Key exclusion criteria (2 listed)
- Absence of consent to be randomized
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccination implementation strategyA multi-faceted influenza vaccination implementation strategy | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Absenteeism among health care workers during influenza epidemics
Time frame: Up to 5 months
Patient morbidity and mortality
Time frame: Up to 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
- Background: PubMed 22032844Osterholm 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.
- Background: PubMed 21295099Hayward 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. No abstract available.
- Background: PubMed 8985189Potter 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. doi: 10.1093/infdis/175.1.1.
- Background: PubMed 10078487Wilde 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. doi: 10.1001/jama.281.10.908.
- Background: PubMed 10675165Carman 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. doi: 10.1016/S0140-6736(99)05190-9.
- Background: PubMed 10493337Saxen 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. doi: 10.1097/00006454-199909000-00007.
- Background: PubMed 2774292Weingarten 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. doi: 10.1016/0196-6553(89)90129-6.
- Background: PubMed 17265398Christini AB, Shutt KA, Byers KE. Influenza vaccination rates and motivators among healthcare worker groups. Infect Control Hosp Epidemiol. 2007 Feb;28(2):171-7. doi: 10.1086/511796. Epub 2007 Jan 17.
- Background: PubMed 9010900Doebbeling 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. doi: 10.1006/pmed.1996.9991.
- Background: PubMed 12181376Smedley 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. doi: 10.1093/occmed/52.5.271.
- Background: PubMed 16102143Canning 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. doi: 10.1111/j.1365-2702.2005.01190.x.
- Background: PubMed 20048239Douville 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.
- Website that was developed as part of the implementation program.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josien Riphagen-Dalhuisen, MD principal investigator
University Medical Centre Groningen/ University of Groningen
Eelko Hak, PhD study director
University Medical Centre Groninge/University of Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza vaccination implementation strategy in people with Influenza, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josien Riphagen-Dalhuisen, MD (+31 (0)6 45 23 80 26, j.riphagen@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza vaccine uptake among health care workers in the UMCs (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481467, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.