A Randomized Controlled Trial of the Effectiveness of the Ottawa Influenza Decision Aid

Influenza Clinical Trial

— OIDA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207557
• Other study ID #: TPA 90189
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: October 24, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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 to be immunized or not immunized?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Élisabeth Bruyère Research Institute	Ottawa	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Bruyere Research Institute, Canadian Center for Vaccinology, Canadian Institutes of Health Research (CIHR), Providence Care

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks after campaign start	No
Secondary	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.	4 weeks after campaign start	No

External Links

•   Canadian Healthcare Influenza Immunization Network