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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03304275
Other study ID # 6007232
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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