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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01207518
• Other study ID #: Guide Cluster RCT
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2010
• Last updated: July 27, 2011
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: July 2011
• Source: Ottawa Hospital Research Institute
• Contact: Anne E McCarthy, MD, FRCP(C)
• Phone: 613-737-8184
• Email: amccarthy[@]ottawahospital.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Élisabeth Bruyère Research Institute	Ottawa	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Bruyere Research Institute, Canadian Center for Vaccinology

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Group - 10% improvement in immunization rates	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	No
Secondary	Improvement in the reporting of immunization rates	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	No

External Links

•   Canadian Healthcare Influenza Immunization Network