Cluster RCT - Evaluating Effectiveness of a Guide and Tools for Influenza Immunization Campaign Planners

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. Identifier: NCT01207518
Recruitment Status : Unknown
Verified July 2011 by Ottawa Hospital Research Institute.
Recruitment status was:  Recruiting
First Posted : September 23, 2010
Last Update Posted : July 28, 2011
Bruyere Research Institute
Canadian Center for Vaccinology
Information provided by:
Ottawa Hospital Research Institute

Brief Summary:

During the 2010-2011 and the 2011-2012 seasonal influenza immunization campaigns, we will recruit a minimum of 46 healthcare organizations to either conduct their campaigns as usual or to use the "Successful Influenza Immunization Campaigns for Healthcare Personnel: A Guide for Campaign Planners and a web-based grab-and-go Tool Kit. At the end of the campaign season we will evaluate the impact of the Guide and web-based tools and assess whether there were changes in immunization rates within each organization and/or if there were significant changes in the management of the campaigns across organizations.

Following completion of the study, we will work with partner organizations to make these tools available to all Canadian healthcare organizations.

Condition or disease Intervention/treatment Phase
Influenza Behavioral: Intervention Group Behavioral: Control Group Not Applicable

Detailed Description:

Keeping nurses, physicians and allied health professionals working during seasonal influenza epidemics is essential. Influenza immunization has been shown to mitigate the adverse health outcomes associated with influenza in the community. When provided to healthcare personnel, influenza vaccine reduces the frequency and severity of influenza outbreaks and reduces influenza-associated morbidity and mortality among patients by reducing the transmission of influenza from healthcare personnel to their vulnerable patients.

Despite abundant evidence of the safety and efficacy of the influenza vaccine, immunization rates among healthcare personnel in hospital and long-term settings remain well below the public health target of 90%. Current initiatives targeted at increasing healthcare personnel immunization rates are having limited success with healthcare personnel immunization rates as low as 2%, but averaging 40% - 60% in most healthcare facilities being reported.

Following the work of the research team over the past two years, a Guide, called "Successful Influenza Immunization Campaigns for Healthcare Personnel: A Guide for Campaign Planners" has been developed, along with web-based "grab and go" tools (the Toolkit). This practical Guide is structured to facilitate the use of the evidence-based research on strategies to increase immunization rates by healthcare planners.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cluster RCT Evaluating the Effectiveness of "Successful Influenza Immunization Campaigns in Healthcare Organizations: A Guide for Campaign Planners, Part of Optimizing Healthcare Workers Interpandemic Vaccine Uptake Study
Study Start Date : August 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Intervention Group
For the intervention group, there will be a Guide facilitator provided by the project team, normally the Project Manager or their delegate. The role of the Guide facilitator will be to provide basic information about the Guide and to facilitate the use of the web-based tools.
Behavioral: Intervention Group
This group of healthcare organizations will be given the Guide, web-based tools and access to a Guide facilitator throughout the study.

Active Comparator: Control Group
The Control Group will be asked to provide immunization rates for the base year and two years of the study, and will be asked about their influenza immunization campaign activities to use as a comparator. They will receive the Guide and web-based tools following completion of the study.
Behavioral: Control Group
This group will provide their immunization rates for the base and study years and will provide information on their campaign activities. No other intervention will be provided.

Primary Outcome Measures :
  1. Intervention Group - 10% improvement in immunization rates [ Time Frame: 2010 to 2012 ]
    In the Intervention Group, a 10% improvement in healthcare personnel immunization rates from the base year (2008-2009) as compared to Year One (2010-2011) and Year Two (2011-2012), assessed using a time-series analysis on how each organization does against themselves and between the Intervention and Control Group. We will also the WHO benchmark of 90%.

Secondary Outcome Measures :
  1. Improvement in the reporting of immunization rates [ Time Frame: 2010-2012 ]
    In both the Intervention and Control Group, we will assess improvement in the reporting of immunization rates, based on the methodology outlined in Appendix 3 of the Guide.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

At least 46 healthcare organizations from across Canada will be selected to participate in the study.

The Guide is designed to be used across different types of healthcare organizations. Potential healthcare organizations will be self-identified, recommended by a project team member, and/or selected from the Canadian Healthcare Association's Guide to Healthcare Facilities. Selected sites must meet the following eligibility criteria:

  • Canadian healthcare organizations who conduct seasonal influenza immunization campaigns
  • Have a systematic approach to collecting healthcare personnel immunization rates and be able to provide accurate and timely reports of immunization rates for categories of healthcare personnel
  • Agree to be randomized to receive the Guide or receive no intervention
  • If randomized to receive the Guide, the organization, including the campaign team and senior management, agrees to commit to adhere to the steps in the Guide to plan, implement, monitor and evaluate their campaign

Exclusion Criteria:

Healthcare organizations who do not meet the above criteria

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 identifier (NCT number): NCT01207518

Contact: Anne E McCarthy, MD, FRCP(C) 613-737-8184
Contact: Lois Crowe 613-562-6262 ext 1263

Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Anne E McCarthy, MD, FRCP(C)    613-737-8184   
Contact: Lois Crowe    613-562-6262 ext 1263   
Élisabeth Bruyère Research Institute Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact: Larry W Chambers, PhD(Epi)    613-562-6262 ext 6045   
Contact: Lois Crowe    613-562-6262 ext 1263   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Bruyere Research Institute
Canadian Center for Vaccinology
Principal Investigator: Larry W Chambers, PhD(Epi) Bruyere Research Institute

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anne McCarthy, Ottawa Hospital Research Institute Identifier: NCT01207518     History of Changes
Other Study ID Numbers: Guide Cluster RCT
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by Ottawa Hospital Research Institute:
healthcare personnel

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs