InfluenzaOIDANCT01207557
A Randomized Controlled Trial of the Effectiveness of the Ottawa Influenza Decision Aid
A study testing Standard Education Only and Standard Education Plus OIDA in people with Influenza, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
The purpose of this study is to determine whether, among healthcare personnel who are undecided about whether to receive influenza vaccine, does use of the OIDA increase or decrease their confidence in their decision to be immunized? Furthermore, does the use of the OIDA affect the intent of the healthcare personnel… 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?
- Standard Education Only and Standard Education Plus OIDA
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2009to Dec 2010
- 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
- For the purposes of this trial, the participating healthcare organizations will be required to:
- Access a database of all healthcare personnel for whom influenza immunization is recommended
- Collect real-time individual level immunization data about when healthcare personnel receive the vaccine
- Generate a line-listing of all healthcare personnel for whom immunization status is not yet known at a pre-specified point in the campaign (at the end of the first four weeks of the campaign)
- Contact the identified healthcare personnel in a manner approved by the healthcare organization, for example, by mail or e-mail, about participating in the trial
- Ideally, have an institutional policy or high-level agreement that requires all healthcare personnel to provide evidence of their immunization status to occupational health.
- Agree to work with the project team to boost the response rate, potentially by providing small tokens of appreciation to staff who complete the questionnaire or by promoting the study through regular communication channels (such as their internal network).
Who cannot join
- Any organization not fitting above criteria
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Élisabeth Bruyère Research Institute
Ottawa, Ontario, K1N 5C8
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of the Ottawa Influenza Decision Aid - A Component of the "Optimizing Healthcare Workers Interpandemic Vaccine Uptake in Acute and Long-term Care" CIHR Project
The purpose of this study is to determine whether, among healthcare personnel who are undecided about whether to receive influenza vaccine, does use of the OIDA increase or decrease their confidence in their decision to be immunized? Furthermore, does the use of the OIDA affect the intent of the healthcare personnel to be immunized or not immunized?
Read the detailed description
Influenza is one of the leading causes of acute respiratory infection and results in significant increases in average life-years lost, hospital lengths of stay and outpatient clinic visits, representing an enormous economic burden for many countries. Healthcare personnel are at particularly high risk of exposure to influenza as they are exposed in both the community and in the workplace. Influenza vaccination for healthcare personnel has been shown to reduce patient mortality in long-term care facilities as well as employee absenteeism and financial costs in acute care settings. The Canadian National Advisory Committee on Immunization (NACI) recommends that influenza immunization programs strive to immunize at least 90% of eligible recipients. In fact, NACI regards influenza immunization of healthcare personnel with direct patient care responsibilities as an essential component of the standard of care for the protection of patients. They consider the refusal of healthcare personnel without contraindications to receive influenza vaccine as a failure in their duty of care to patients. Despite national recommendations and proven effectiveness, influenza immunization coverage rates among healthcare personnel remain disappointingly low. In Canada, coverage rates among healthcare personnel range from 26-61% while in the US only 38% of healthcare personnel were immunized in 2002.
The decision to accept or refuse influenza vaccine each year may be a difficult one for many healthcare personnel. Decisional conflict, a term used to describe the difficulty experienced by an individual who simultaneously tends to both accept and reject a given course of action, occurs in many medical decisions where the best choice often differs depending on how individuals weigh the risks and benefits, and has been shown to contribute to poor vaccine uptake. In a review of literature from 1985 to 2004, it was found that healthcare personnel experience decisional conflict related to misperceptions about influenza, its risks, the role of healthcare personnel in its transmission to patients, and the importance and risks of vaccination.
Patient decision aids are tools that help people become involved in decision making by providing information about the options and outcomes, and clarifying personal values. They are designed to complement, rather than replace, counselling from a health practitioner. The use of decision aids has been shown to decrease decisional conflict and result in improved knowledge, more realistic expectations of benefit/risks and more active participation of individuals in decision-making. To date, no decision aids have been published that focus on influenza vaccination and none have been developed for healthcare personnel. Furthermore, the effect of a decision aid on the uptake of vaccine in healthcare personnel is unknown.
The peer-reviewed Ottawa Influenza Decision Aid (OIDA) was developed to respond to the aforementioned misconceptions and identify barriers of vaccine uptake in healthcare personnel. The OIDA presents evidence-based information and guides the individual through the decision-making process, including deliberation of personal values and beliefs.
- Conditions
- Influenza
- Being tested
- Standard Education Only, Standard Education Plus OIDA
- Keywords
- Healthcare personnel, influenza, immunization, flu, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Education OnlyBehavioural
50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision
Standard Education Plus OIDABehavioural
50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision
| Study group | Role | What they receive |
|---|---|---|
| Standard education only | Active comparator | 50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision Receives: Behavioral: Standard Education Only |
| Standard Education plus OIDA | Active comparator | 50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials plus the Ottawa Influenza Decision Aid and tested on their confidence with their immunization decision Receives: Behavioral: Standard Education Plus OIDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Confidence in Individual Healthcare Personnel in their Decision to be Immunized or not Against Influenza
The level of confidence with which healthcare personnel reached a decision regarding immunization will be operationalized as a five-point ordinal scale with values ranging between 1 and 5.
Measured: 4 weeks after campaign start
Secondary outcomes (1)
Do Healthcare Personnel Decide to be Immunized After Completing the OIDA?
In keeping with the second objective of the trial, which is to measure the individual healthcare worker's decision to become immunized, the corresponding outcome measure is defined as a nominal variable registering the healthcare worker's self-reported course of action, to be used for estimating the rate of influenza immunization in each arm of the trial. In addition, the Occupational Health Department will provide information about the level of overall healthcare personnel immunization during running of the campaign after its first four weeks of operation.
Measured: 4 weeks after campaign start
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 2009
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bruyère Health Research Institute., Providence Health & Services, Canadian Center for Vaccinology, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Anne E. McCarthy, MD, Principal investigator, Ottawa Hospital Research InstituteLarry W Chambers, PhD(Epi), Principal investigator, Bruyère Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207557
- Sponsor's protocol ID
- TPA 90189
- Acronym
- OIDA
- Status last verified
- Oct 2011
- First submitted
- 21 Sep 2010
- Last updated
- 26 Oct 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 20643836
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of the Ottawa Influenza Decision Aid - A Component of the "Optimizing Healthcare Workers Interpandemic Vaccine Uptake in Acute and Long-term Care" CIHR Project
- ClinicalTrials.gov ID
- NCT01207557
- Acronym / sponsor ID
- OIDA / TPA 90189
- Conditions
- Influenza
- Keywords
- Healthcare personnel, influenza, immunization, flu, vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Bruyère Health Research Institute., Providence Health & Services, Canadian Center for Vaccinology, Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- 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.
The purpose of this study is to determine whether, among healthcare personnel who are undecided about whether to receive influenza vaccine, does use of the OIDA increase or decrease their confidence in their decision to be immunized? Furthermore, does the use of the OIDA affect the intent of the healthcare personnel to be immunized or not immunized?
Detailed description
Influenza is one of the leading causes of acute respiratory infection and results in significant increases in average life-years lost, hospital lengths of stay and outpatient clinic visits, representing an enormous economic burden for many countries. Healthcare personnel are at particularly high risk of exposure to influenza as they are exposed in both the community and in the workplace. Influenza vaccination for healthcare personnel has been shown to reduce patient mortality in long-term care facilities as well as employee absenteeism and financial costs in acute care settings. The Canadian National Advisory Committee on Immunization (NACI) recommends that influenza immunization programs strive to immunize at least 90% of eligible recipients. In fact, NACI regards influenza immunization of healthcare personnel with direct patient care responsibilities as an essential component of the standard of care for the protection of patients. They consider the refusal of healthcare personnel without contraindications to receive influenza vaccine as a failure in their duty of care to patients. Despite national recommendations and proven effectiveness, influenza immunization coverage rates among healthcare personnel remain disappointingly low. In Canada, coverage rates among healthcare personnel range from 26-61% while in the US only 38% of healthcare personnel were immunized in 2002.
The decision to accept or refuse influenza vaccine each year may be a difficult one for many healthcare personnel. Decisional conflict, a term used to describe the difficulty experienced by an individual who simultaneously tends to both accept and reject a given course of action, occurs in many medical decisions where the best choice often differs depending on how individuals weigh the risks and benefits, and has been shown to contribute to poor vaccine uptake. In a review of literature from 1985 to 2004, it was found that healthcare personnel experience decisional conflict related to misperceptions about influenza, its risks, the role of healthcare personnel in its transmission to patients, and the importance and risks of vaccination.
Patient decision aids are tools that help people become involved in decision making by providing information about the options and outcomes, and clarifying personal values. They are designed to complement, rather than replace, counselling from a health practitioner. The use of decision aids has been shown to decrease decisional conflict and result in improved knowledge, more realistic expectations of benefit/risks and more active participation of individuals in decision-making. To date, no decision aids have been published that focus on influenza vaccination and none have been developed for healthcare personnel. Furthermore, the effect of a decision aid on the uptake of vaccine in healthcare personnel is unknown.
The peer-reviewed Ottawa Influenza Decision Aid (OIDA) was developed to respond to the aforementioned misconceptions and identify barriers of vaccine uptake in healthcare personnel. The OIDA presents evidence-based information and guides the individual through the decision-making process, including deliberation of personal values and beliefs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard education only | Active comparator | Behavioral: Standard Education Only50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision |
| Standard Education plus OIDA | Active comparator | Behavioral: Standard Education Plus OIDA50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials plus the Ottawa Influenza Decision Aid and tested on their confidence with their immunization decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For the purposes of this trial, the participating healthcare organizations will be required to:
- Access a database of all healthcare personnel for whom influenza immunization is recommended
- Collect real-time individual level immunization data about when healthcare personnel receive the vaccine
- Generate a line-listing of all healthcare personnel for whom immunization status is not yet known at a pre-specified point in the campaign (at the end of the first four weeks of the campaign)
- Contact the identified healthcare personnel in a manner approved by the healthcare organization, for example, by mail or e-mail, about participating in the trial
Key exclusion criteria (1 listed)
- Any organization not fitting 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 |
|---|---|---|
| Standard Education Only50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision | Behavioural | Standard education only |
| Standard Education Plus OIDA50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision | Behavioural | Standard Education plus OIDA |
Primary outcome
Level of Confidence in Individual Healthcare Personnel in their Decision to be Immunized or not Against Influenza
Time frame: 4 weeks after campaign start
The level of confidence with which healthcare personnel reached a decision regarding immunization will be operationalized as a five-point ordinal scale with values ranging between 1 and 5.
1 secondary outcome
Do Healthcare Personnel Decide to be Immunized After Completing the OIDA?
Time frame: 4 weeks after campaign start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
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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.
Anne E. McCarthy, MD principal investigator
Ottawa Hospital Research Institute
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 Standard Education Only and Standard Education Plus OIDA 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 7 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: finished, as of the sponsor's last update on 26 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Confidence in Individual Healthcare Personnel in their Decision to be Immunized or not Against Influenza (time frame: 4 weeks after campaign start). 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 NCT01207557, which also lists 1 linked publication.
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 26 Oct 2011.