The Feasibility of Pertussis Immunization in a Canadian Emergency Department

NCT ID: NCT03304275

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2017-12-20

Brief Summary

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Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine to patients presenting to the emergency department. Rates of vaccination as well as effects on department efficiency will be measured.

Detailed Description

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This study is a prospective randomized, controlled trial of two strategies to provide patients with the pertussis vaccine. Eligible adult patients with be offered pertussis vaccination in the Emergency Department vs. a referral to Public Health for pertussis vaccination. The effect of both strategies on triage time as well as measure of emergency department efficiency including length of stay, time to physician and left without being seen rates will be compared. At a four-month follow up, rates of pertussis vaccination will be measured.

Conditions

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Pertussis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Emergency Department vaccination group

Pertussis (Tdap) vaccine offered/administered in the Emergency Department

Group Type EXPERIMENTAL

Tdap

Intervention Type BEHAVIORAL

Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine

Public Health referral group

Public Health referral for Pertussis (Tdap) vaccine administration offered

Group Type EXPERIMENTAL

Tdap

Intervention Type BEHAVIORAL

Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine

Interventions

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Tdap

Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine

Intervention Type BEHAVIORAL

Other Intervention Names

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Boostrix

Eligibility Criteria

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Inclusion Criteria

* Adults age 18 and above
* Have not received Tdap vaccine as an adult (age 18 and above) or have not received Tdap vaccine within 10 years, or unsure of vaccination status

Exclusion Criteria

* Acute significant illness (Canadian Triage and Acuity Scale = 1)
* Deemed "in too much distress" by triage nurse
* Acute Febrile illness
* Allergy to vaccine or vaccine components
* Pts presenting for wound care (are normally given the vaccine as part of wound care)
* Pregnancy \< 26 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Queen Elizabeth Hospital

OTHER

Sponsor Role collaborator

University of Prince Edward Island

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Sibley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Prince Edward Island

Locations

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Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, Canada

Site Status

Countries

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Canada

Other Identifiers

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6007232

Identifier Type: -

Identifier Source: org_study_id

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