NCT01207557

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

7 months

First QC Date

September 21, 2010

Last Update Submit

October 24, 2011

Conditions

Influenza

Keywords

Healthcare personnelinfluenzaimmunizationfluvaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Do Healthcare Personnel Decide to be Immunized After Completing the OIDA?

    4 weeks after campaign start

Study Arms (2)

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

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

Behavioral: Standard Education Plus OIDA

Interventions

Standard Education OnlyBEHAVIORAL

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 only
Standard Education Plus OIDABEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Any organization not fitting above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Élisabeth Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

Location

Related 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.

    PMID: 20643836BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Anne E. McCarthy, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • Larry W Chambers, PhD(Epi)

    Bruyère Health Research Institute.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 23, 2010

Study Start

August 1, 2009

Primary Completion

March 1, 2010

Study Completion

December 1, 2010

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations

CA(2)