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

NCT ID: NCT01207518

Last Updated: 2011-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-08-31

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.

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: BEHAVIORAL

This group of healthcare organizations will be given the Guide, web-based tools and access to a Guide facilitator throughout the study.

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.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: BEHAVIORAL

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.

Interventions

Intervention Group

This group of healthcare organizations will be given the Guide, web-based tools and access to a Guide facilitator throughout the study.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bruyère Health Research Institute.

OTHER

Sponsor Role: collaborator

Canadian Center for Vaccinology

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Ottawa Hospital Research Institute

Principal Investigators

Larry W Chambers, PhD(Epi)

Role: PRINCIPAL_INVESTIGATOR

Bruyère Health Research Institute.

Locations

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Élisabeth Bruyère Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Anne E McCarthy, MD, FRCP(C)

Role: CONTACT

amccarthy@ottawahospital.on.ca

613-737-8184

Lois Crowe

Role: CONTACT

lcrowe@bruyere.org

613-562-6262 ext. 1263

Facility Contacts

Anne E McCarthy, MD, FRCP(C)

Role: primary

amccarthy@ottawahospital.on.ca

613-737-8184

Lois Crowe

Role: backup

lcrowe@bruyere.org

613-562-6262 ext. 1263

Larry W Chambers, PhD(Epi)

Role: primary

lchambers@bruyere.org

613-562-6262 ext. 6045

Lois Crowe

Role: backup

lcrowe@bruyere.org

613-562-6262 ext. 1263

References

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.

Reference Type: BACKGROUND

PMID: 20643836 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25781888 (View on PubMed)

Other Identifiers

Guide Cluster RCT

Identifier Type: -

Identifier Source: org_study_id