The Feasibility of Pertussis Immunization in a Canadian Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Pertussis
• Intervention / Treatment: Behavioral: Tdap

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 Type: Interventional
• Enrollment (Actual): 644
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, PO Box 6600
      • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emergency Department vaccination group; Pertussis (Tdap) vaccine offered/administered in the Emergency Department	Behavioral: Tdap; Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine; Other Names: Boostrix
Experimental: Public Health referral group; Public Health referral for Pertussis (Tdap) vaccine administration offered	Behavioral: Tdap; Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine; Other Names: Boostrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of immunization	Rate of patients receiving Tdap vaccine	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Length of Stay (mins, secs) for all patients presenting to the emergency. department on study days.	One day
Left with out being seen rate	Rate of patients leaving without being seen by a physician on study days.	One day
Time to physician	Time to be seen by emergency physician after triage (mins, secs) on study days.	One day
Patient refusals	Reasons for patient vaccination refusal	One day
Nursing satisfaction	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	One day
Additional vaccine received	Additional vaccines administered in the Public Health referral arm	One day
Triage time	Time (in seconds) required to triage eligible patients in the emergency department	One day

Collaborators and Investigators

• Sponsor: University of Prince Edward Island
• Collaborators: The Queen Elizabeth Hospital
• Investigators: Principal Investigator: Aaron Sibley, MD, University of Prince Edward Island

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Emergency Department; Vaccination; Pertussis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Emergencies; Whooping Cough
• Other Study ID Numbers: 6007232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No