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

Primary Purpose

Influenza

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention Group
Control Group
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, immunization, healthcare personnel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ottawa Hospital Research InstituteRecruiting
  • Élisabeth Bruyère Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.

Full Information

First Posted
September 21, 2010
Last Updated
July 27, 2011
Sponsor
Ottawa Hospital Research Institute
Collaborators
Bruyere Research Institute, Canadian Center for Vaccinology
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1. Study Identification

Unique Protocol Identification Number
NCT01207518
Brief Title
Cluster RCT - Evaluating Effectiveness of a Guide and Tools for Influenza Immunization Campaign Planners
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Bruyere Research Institute, Canadian Center for Vaccinology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, immunization, healthcare personnel

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
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
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention Group - 10% improvement in immunization rates
Description
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%.
Time Frame
2010 to 2012
Secondary Outcome Measure Information:
Title
Improvement in the reporting of immunization rates
Description
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.
Time Frame
2010-2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne E McCarthy, MD, FRCP(C)
Phone
613-737-8184
Email
amccarthy@ottawahospital.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lois Crowe
Phone
613-562-6262
Ext
1263
Email
lcrowe@bruyere.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry W Chambers, PhD(Epi)
Organizational Affiliation
Bruyere Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne E McCarthy, MD, FRCP(C)
Phone
613-737-8184
Email
amccarthy@ottawahospital.on.ca
First Name & Middle Initial & Last Name & Degree
Lois Crowe
Phone
613-562-6262
Ext
1263
Email
lcrowe@bruyere.org
Facility Name
Élisabeth Bruyère Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larry W Chambers, PhD(Epi)
Phone
613-562-6262
Ext
6045
Email
lchambers@bruyere.org
First Name & Middle Initial & Last Name & Degree
Lois Crowe
Phone
613-562-6262
Ext
1263
Email
lcrowe@bruyere.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
20643836
Citation
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.
Results Reference
background
PubMed Identifier
25781888
Citation
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.
Results Reference
derived

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

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