- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01207518
Cluster RCT - Evaluating Effectiveness of a Guide and Tools for Influenza Immunization Campaign Planners
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne E McCarthy, MD, FRCP(C)
- Phone Number: 613-737-8184
- Email: amccarthy@ottawahospital.on.ca
Study Contact Backup
- Name: Lois Crowe
- Phone Number: 1263 613-562-6262
- Email: lcrowe@bruyere.org
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- Ottawa Hospital Research Institute
-
Contact:
- Anne E McCarthy, MD, FRCP(C)
- Phone Number: 613-737-8184
- Email: amccarthy@ottawahospital.on.ca
-
Contact:
- Lois Crowe
- Phone Number: 1263 613-562-6262
- Email: lcrowe@bruyere.org
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Ottawa, Ontario, Canada, K1N 5C8
- Recruiting
- Élisabeth Bruyère Research Institute
-
Contact:
- Lois Crowe
- Phone Number: 1263 613-562-6262
- Email: lcrowe@bruyere.org
-
Contact:
- Larry W Chambers, PhD(Epi)
- Phone Number: 6045 613-562-6262
- Email: lchambers@bruyere.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
2010 to 2012
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2010-2012
|
Collaborators and Investigators
Investigators
- Principal Investigator: Larry W Chambers, PhD(Epi), Bruyère Research Institute
Publications and helpful links
General Publications
- Lam PP, Chambers LW, MacDougall DM, McCarthy AE. Seasonal influenza vaccination campaigns for health care personnel: systematic review. CMAJ. 2010 Sep 7;182(12):E542-8. doi: 10.1503/cmaj.091304. Epub 2010 Jul 19.
- Chambers LW, Crowe L, Lam PP, MacDougall D, McNeil S, Roth V, Suh K, Dalzell C, Baker D, Ramsay H, DeCoutere S, Hall HL, McCarthy AE. A new approach to improving healthcare personnel influenza immunization programs: a randomized controlled trial. PLoS One. 2015 Mar 17;10(3):e0118368. doi: 10.1371/journal.pone.0118368. eCollection 2015.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Guide Cluster RCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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