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A Randomized Controlled Trial of the Effectiveness of the Ottawa Influenza Decision Aid (OIDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01207557
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : October 26, 2011
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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 to be immunized or not immunized?

Condition or disease Intervention/treatment
Influenza Behavioral: Standard Education Only Behavioral: Standard Education Plus OIDA

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Study Start Date : August 2009
Primary Completion Date : March 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Standard education only
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
Behavioral: Standard Education Only
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
Active Comparator: Standard Education plus OIDA
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
Behavioral: Standard Education Plus OIDA
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Do Healthcare Personnel Decide to be Immunized After Completing the OIDA? [ Time Frame: 4 weeks after campaign start ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For the purposes of this trial, the participating healthcare organizations will be required to:

  1. Access a database of all healthcare personnel for whom influenza immunization is recommended
  2. Collect real-time individual level immunization data about when healthcare personnel receive the vaccine
  3. 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)
  4. 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
  5. Ideally, have an institutional policy or high-level agreement that requires all healthcare personnel to provide evidence of their immunization status to occupational health.
  6. 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).

Exclusion Criteria:

Any organization not fitting above criteria

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207557


Locations
Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Élisabeth Bruyère Research Institute
Ottawa, Ontario, Canada, K1N 5C8
Sponsors and Collaborators
Ottawa Hospital Research Institute
Bruyere Research Institute
Providence Care
Canadian Center for Vaccinology
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Anne E. McCarthy, MD Ottawa Hospital Research Institute
Principal Investigator: Larry W Chambers, PhD(Epi) Bruyere Research Institute
More Information

Additional Information:
Publications:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01207557     History of Changes
Other Study ID Numbers: TPA 90189
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Keywords provided by Ottawa Hospital Research Institute:
Healthcare personnel
influenza
immunization
flu
vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs