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Completed

NCT Number: NCT03304275

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.

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Key information

Conditions

Pertussis Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Disease Attributes Emergencies Gram-Negative Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, PO Box 6600, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tdap

Behavioral

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

Other names: Boostrix

Primary outcomes

  1. Rate of immunization

    Time frame: One day

    Rate of patients receiving Tdap vaccine

Secondary outcomes

  1. Length of Stay

    Time frame: One day

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

  2. Left with out being seen rate

    Time frame: One day

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

  3. Time to physician

    Time frame: One day

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

  4. Patient refusals

    Time frame: One day

    Reasons for patient vaccination refusal

  5. Nursing satisfaction

    Time frame: One day

    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

  6. Additional vaccine received

    Time frame: One day

    Additional vaccines administered in the Public Health referral arm

  7. Triage time

    Time frame: One day

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

Sponsors and collaborators

Lead sponsor

University of Prince Edward Island

Other

Collaborators

  • The Queen Elizabeth Hospital

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2017
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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