The Feasibility of Pertussis Immunization in a Canadian Emergency Department

Pertussis Clinical Trial

Official title:

The Feasibility of Pertussis Immunization in a Canadian Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304275
• Other study ID #: 6007232
• Status: Completed
• Phase: N/A
• First received: September 25, 2017
• Last updated: January 24, 2018
• Start date: July 10, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: University of Prince Edward Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 644
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Pertussis
• Whooping Cough

Intervention

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

Locations

Country	Name	City	State
Canada	Queen Elizabeth Hospital	Charlottetown	Prince Edward Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Prince Edward Island	The Queen Elizabeth Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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