The Feasibility of Pertussis Immunization in a Canadian Emergency Department

Not Applicable

Completed

• Conditions: Pertussis
• Interventions: Behavioral: Tdap

• Registration Number: NCT03304275
• Lead Sponsor: University of Prince Edward Island

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-07-10
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-06
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 644

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emergency Department vaccination group	Tdap	Pertussis (Tdap) vaccine offered/administered in the Emergency Department
Public Health referral group	Tdap	Public Health referral for Pertussis (Tdap) vaccine administration offered

Primary Outcome Measures

Name	Time	Method
Rate of immunization	One day	Rate of patients receiving Tdap vaccine

Secondary Outcome Measures

Name	Time	Method
Triage time	One day	Time (in seconds) required to triage eligible patients in the emergency department
Time to physician	One day	Time to be seen by emergency physician after triage (mins, secs) on study days.
Length of Stay	One day	Length of Stay (mins, secs) for all patients presenting to the emergency. department on study days.
Left with out being seen rate	One day	Rate of patients leaving without being seen by a physician on study days.
Patient refusals	One day	Reasons for patient vaccination refusal
Additional vaccine received	One day	Additional vaccines administered in the Public Health referral arm
Nursing satisfaction	One day	Five statements rated on 5 point likert scale (strongly disagree (1) to strongly agree (5)). The immunization strategy significantly increased my workload; patient care was negatively affected by the immunization strategy; I was unable to provide the standard of care because of the immunization strategy; patient flow within the department was negatively affected by the immunization strategy; the ED should implement the immunization strategy

Trial Locations

Locations (1)

Queen Elizabeth Hospital; 🇨🇦 Charlottetown, Prince Edward Island, Canada