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

Primary Purpose

Influenza

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Influenza vaccination implementation strategy
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring influenza vaccination, intervention mapping, hospital care, respiratory infections, vaccination

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Centre Groningen
  • University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Influenza vaccination implementation strategy applied.

Usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 10, 2011
Last Updated
December 19, 2011
Sponsor
University Medical Center Groningen
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01481467
Brief Title
Evaluation of an Influenza Vaccination Implementation Strategy for Hospital Health Care Workers
Official Title
Evaluation of a Multi-faceted Influenza Vaccination Implementation Strategy for Health Care Workers in Hospitals
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza vaccination, intervention mapping, hospital care, respiratory infections, vaccination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Influenza vaccination implementation strategy applied.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Behavioral
Intervention Name(s)
Influenza vaccination implementation strategy
Intervention Description
A multi-faceted influenza vaccination implementation strategy
Primary Outcome Measure Information:
Title
Influenza vaccine uptake among health care workers in the UMCs
Description
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.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Absenteeism among health care workers during influenza epidemics
Description
Absenteeism among HCWs is assessed by means of data provided by the department of occupational health at the end of both influenza seasons.
Time Frame
Up to 5 months
Title
Patient morbidity and mortality
Description
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.
Time Frame
Up to 5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josien Riphagen-Dalhuisen, MD
Phone
+31 (0)6 45 23 80 26
Email
j.riphagen@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Eelko Hak, PhD
Phone
+31 (0)50 363 7576
Email
e.hak@rug.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josien Riphagen-Dalhuisen, MD
Organizational Affiliation
University Medical Centre Groningen/ University of Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eelko Hak, PhD
Organizational Affiliation
University Medical Centre Groninge/University of Groningen
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Completed
Facility Name
University Medical Centre
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Links:
URL
http://www.bewustgepriktvooru.nl
Description
Website that was developed as part of the implementation program.

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

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