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

NCT01207518 | Unknown

• 1 other identifier: Guide Cluster RCT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza

Keywords

influenza; immunization; healthcare personnel

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Improvement in the reporting of immunization rates

  2010-2012

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Intervention Group BEHAVIORAL

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

Intervention Group

Control Group 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Healthcare organizations who do not meet the above criteria

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Bruyère Health Research Institute.: collaborator
• Canadian Center for Vaccinology: collaborator

Study Sites (2)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Élisabeth Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 20643836 BACKGROUND

• 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.

  PMID: 25781888 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Larry W Chambers, PhD(Epi)

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne E McCarthy, MD, FRCP(C)

CONTACT

613-737-8184; amccarthy@ottawahospital.on.ca

Lois Crowe

CONTACT

613-562-6262; lcrowe@bruyere.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 23, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

CA (2)