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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ottawa Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bruyere Research Institute
Canadian Center for Vaccinology
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01207518
First received: September 21, 2010
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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 Intervention
Influenza
Behavioral: Intervention Group
Behavioral: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Intervention Group - 10% improvement in immunization rates [ Time Frame: 2010 to 2012 ] [ Designated as safety issue: No ]
    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:
  • Improvement in the reporting of immunization rates [ Time Frame: 2010-2012 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 46
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207518

Contacts
Contact: Anne E McCarthy, MD, FRCP(C) 613-737-8184 amccarthy@ottawahospital.on.ca
Contact: Lois Crowe 613-562-6262 ext 1263 lcrowe@bruyere.org

Locations
Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Anne E McCarthy, MD, FRCP(C)    613-737-8184    amccarthy@ottawahospital.on.ca   
Contact: Lois Crowe    613-562-6262 ext 1263    lcrowe@bruyere.org   
Élisabeth Bruyère Research Institute Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact: Larry W Chambers, PhD(Epi)    613-562-6262 ext 6045    lchambers@bruyere.org   
Contact: Lois Crowe    613-562-6262 ext 1263    lcrowe@bruyere.org   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Bruyere Research Institute
Canadian Center for Vaccinology
Investigators
Principal Investigator: Larry W Chambers, PhD(Epi) Bruyere Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: Anne McCarthy, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01207518     History of Changes
Other Study ID Numbers: Guide Cluster RCT
Study First Received: September 21, 2010
Last Updated: July 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
influenza
immunization
healthcare personnel

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

ClinicalTrials.gov processed this record on October 20, 2014