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CompletedNCT03304275Updated Jan 26, 2018

The Feasibility of Pertussis Immunization in a Canadian Emergency Department

An interventional study of Tdap in Pertussis, sponsored by University of Prince Edward Island. Completed at 1 site in Canada. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-26.

Sponsored by University of Prince Edward Island · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
644
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pertussis

Keywords

  • Pertussis
  • Vaccination
  • Emergency Department
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
644 participants (actual)

Study arms

  • Experimental
    Emergency Department vaccination group

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

    Behavioral: Tdap

  • Experimental
    Public Health referral group

    Public Health referral for Pertussis (Tdap) vaccine administration offered

    Behavioral: Tdap

Interventions

  • BehavioralTdap

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

    Also known as: Boostrix

05

What researchers measure

Primary outcomes

  1. Rate of immunization

    Rate of patients receiving Tdap vaccine

    Time frame: One day

Secondary outcomes

  1. Length of Stay

    Length of Stay (mins, secs) for all patients presenting to the emergency. department on study days.

    Time frame: One day

  2. Left with out being seen rate

    Rate of patients leaving without being seen by a physician on study days.

    Time frame: One day

  3. Time to physician

    Time to be seen by emergency physician after triage (mins, secs) on study days.

    Time frame: One day

  4. Patient refusals

    Reasons for patient vaccination refusal

    Time frame: One day

  5. 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

    Time frame: One day

  6. Additional vaccine received

    Additional vaccines administered in the Public Health referral arm

    Time frame: One day

  7. Triage time

    Time (in seconds) required to triage eligible patients in the emergency department

    Time frame: One day

06

Study locations

1 site
  • Queen Elizabeth Hospital
    Charlottetown, Prince Edward Island PO Box 6600, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03304275
Lead sponsor
University of Prince Edward Island
Collaborators
The Queen Elizabeth Hospital
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Jul 10, 2017
Primary completion
Dec 20, 2017
Completion
Dec 20, 2017
Last update
Jan 26, 2018

Study contacts

Aaron Sibley, MD
principal investigator · University of Prince Edward Island

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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