Influenza Clinical Trial
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?
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |