InfluenzaNCT01207518
Cluster RCT - Evaluating Effectiveness of a Guide and Tools for Influenza Immunization Campaign Planners
A study testing Intervention Group in people with Influenza, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Intervention Group
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Healthcare organizations who do not meet the above criteria
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Anne E McCarthy, MD, FRCP(C), 613-737-8184, amccarthy@ottawahospital.on.ca
Lois Crowe, 613-562-6262 ext. 1263, lcrowe@bruyere.org
- Recruiting
Élisabeth Bruyère Research Institute
Ottawa, Ontario, K1N 5C8
Larry W Chambers, PhD(Epi), 613-562-6262 ext. 6045, lchambers@bruyere.org
Lois Crowe, 613-562-6262 ext. 1263, lcrowe@bruyere.org
About this study
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
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.
Read the 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
- Being tested
- Intervention Group, Control Group
- Keywords
- influenza, immunization, healthcare personnel
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
This group of healthcare organizations will be given the Guide, web-based tools and access to a Guide facilitator throughout the study.
Control GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 2010 to 2012
Secondary outcomes (1)
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.
Measured: 2010-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bruyère Health Research Institute., Canadian Center for Vaccinology
- Investigators
- Larry W Chambers, PhD(Epi), Principal investigator, Bruyère Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207518
- Sponsor's protocol ID
- Guide Cluster RCT
- Status last verified
- Jul 2011
- First submitted
- 21 Sep 2010
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20643836Chambers 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.
PubMed 25781888
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01207518
- Acronym / sponsor ID
- Guide Cluster RCT
- Conditions
- Influenza
- Keywords
- influenza, immunization, healthcare personnel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Bruyère Health Research Institute., Canadian Center for Vaccinology
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupFor 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. |
| Control Group | Active comparator | Behavioral: Control GroupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Healthcare organizations who do not meet the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThis group of healthcare organizations will be given the Guide, web-based tools and access to a Guide facilitator throughout the study. | Behavioural | Intervention Group |
| Control GroupThis 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. | Behavioural | Control Group |
Primary outcome
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%.
1 secondary outcome
Improvement in the reporting of immunization rates
Time frame: 2010-2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Background: PubMed 20643836Lam 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.
- Derived from this study: PubMed 25781888Chambers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry W Chambers, PhD(Epi) principal investigator
Bruyère Health Research Institute.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Influenza, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne E McCarthy, MD, FRCP(C) (613-737-8184, amccarthy@ottawahospital.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Group - 10% improvement in immunization rates (time frame: 2010 to 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207518, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.