search
Back to results

The Feasibility of Pertussis Immunization in a Canadian Emergency Department

Primary Purpose

Pertussis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tdap
Sponsored by
University of Prince Edward Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pertussis focused on measuring Pertussis, Vaccination, Emergency Department

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Emergency Department vaccination group

Public Health referral group

Arm Description

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

Public Health referral for Pertussis (Tdap) vaccine administration offered

Outcomes

Primary Outcome Measures

Rate of immunization
Rate of patients receiving Tdap vaccine

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2017
Last Updated
January 24, 2018
Sponsor
University of Prince Edward Island
Collaborators
The Queen Elizabeth Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03304275
Brief Title
The Feasibility of Pertussis Immunization in a Canadian Emergency Department
Official Title
The Feasibility of Pertussis Immunization in a Canadian Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Prince Edward Island
Collaborators
The Queen Elizabeth Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis
Keywords
Pertussis, Vaccination, Emergency Department

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
644 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emergency Department vaccination group
Arm Type
Experimental
Arm Description
Pertussis (Tdap) vaccine offered/administered in the Emergency Department
Arm Title
Public Health referral group
Arm Type
Experimental
Arm Description
Public Health referral for Pertussis (Tdap) vaccine administration offered
Intervention Type
Behavioral
Intervention Name(s)
Tdap
Other Intervention Name(s)
Boostrix
Intervention Description
Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine
Primary Outcome Measure Information:
Title
Rate of immunization
Description
Rate of patients receiving Tdap vaccine
Time Frame
One day
Secondary Outcome Measure Information:
Title
Length of Stay
Description
Length of Stay (mins, secs) for all patients presenting to the emergency. department on study days.
Time Frame
One day
Title
Left with out being seen rate
Description
Rate of patients leaving without being seen by a physician on study days.
Time Frame
One day
Title
Time to physician
Description
Time to be seen by emergency physician after triage (mins, secs) on study days.
Time Frame
One day
Title
Patient refusals
Description
Reasons for patient vaccination refusal
Time Frame
One day
Title
Nursing satisfaction
Description
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
Time Frame
One day
Title
Additional vaccine received
Description
Additional vaccines administered in the Public Health referral arm
Time Frame
One day
Title
Triage time
Description
Time (in seconds) required to triage eligible patients in the emergency department
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Sibley, MD
Organizational Affiliation
University of Prince Edward Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
PO Box 6600
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Feasibility of Pertussis Immunization in a Canadian Emergency Department

We'll reach out to this number within 24 hrs