<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03304275</url>
  </required_header>
  <id_info>
    <org_study_id>6007232</org_study_id>
    <nct_id>NCT03304275</nct_id>
  </id_info>
  <brief_title>The Feasibility of Pertussis Immunization in a Canadian Emergency Department</brief_title>
  <official_title>The Feasibility of Pertussis Immunization in a Canadian Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Prince Edward Island</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Queen Elizabeth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Prince Edward Island</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine to&#xD;
      patients presenting to the emergency department. Rates of vaccination as well as effects on&#xD;
      department efficiency will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective randomized, controlled trial of two strategies to provide&#xD;
      patients with the pertussis vaccine. Eligible adult patients with be offered pertussis&#xD;
      vaccination in the Emergency Department vs. a referral to Public Health for pertussis&#xD;
      vaccination. The effect of both strategies on triage time as well as measure of emergency&#xD;
      department efficiency including length of stay, time to physician and left without being seen&#xD;
      rates will be compared. At a four-month follow up, rates of pertussis vaccination will be&#xD;
      measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">December 20, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of immunization</measure>
    <time_frame>One day</time_frame>
    <description>Rate of patients receiving Tdap vaccine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>One day</time_frame>
    <description>Length of Stay (mins, secs) for all patients presenting to the emergency. department on study days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left with out being seen rate</measure>
    <time_frame>One day</time_frame>
    <description>Rate of patients leaving without being seen by a physician on study days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to physician</measure>
    <time_frame>One day</time_frame>
    <description>Time to be seen by emergency physician after triage (mins, secs) on study days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient refusals</measure>
    <time_frame>One day</time_frame>
    <description>Reasons for patient vaccination refusal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nursing satisfaction</measure>
    <time_frame>One day</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional vaccine received</measure>
    <time_frame>One day</time_frame>
    <description>Additional vaccines administered in the Public Health referral arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triage time</measure>
    <time_frame>One day</time_frame>
    <description>Time (in seconds) required to triage eligible patients in the emergency department</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">644</enrollment>
  <condition>Pertussis</condition>
  <arm_group>
    <arm_group_label>Emergency Department vaccination group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pertussis (Tdap) vaccine offered/administered in the Emergency Department</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Public Health referral group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Public Health referral for Pertussis (Tdap) vaccine administration offered</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tdap</intervention_name>
    <description>Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine</description>
    <arm_group_label>Emergency Department vaccination group</arm_group_label>
    <arm_group_label>Public Health referral group</arm_group_label>
    <other_name>Boostrix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18 and above&#xD;
&#xD;
          -  Have not received Tdap vaccine as an adult (age 18 and above) or have not received&#xD;
             Tdap vaccine within 10 years, or unsure of vaccination status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute significant illness (Canadian Triage and Acuity Scale = 1)&#xD;
&#xD;
          -  Deemed &quot;in too much distress&quot; by triage nurse&#xD;
&#xD;
          -  Acute Febrile illness&#xD;
&#xD;
          -  Allergy to vaccine or vaccine components&#xD;
&#xD;
          -  Pts presenting for wound care (are normally given the vaccine as part of wound care)&#xD;
&#xD;
          -  Pregnancy &lt; 26 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Sibley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Prince Edward Island</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Charlottetown</city>
        <state>Prince Edward Island</state>
        <zip>PO Box 6600</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pertussis</keyword>
  <keyword>Vaccination</keyword>
  <keyword>Emergency Department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whooping Cough</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03304275
org study id: 6007232
nct id: NCT03304275
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Rate of immunization
time frame: One day
description: Rate of patients receiving Tdap vaccine
measure: Length of Stay
time frame: One day
description: Length of Stay (mins, secs) for all patients presenting to the emergency. department on study days.
measure: Left with out being seen rate
time frame: One day
description: Rate of patients leaving without being seen by a physician on study days.
measure: Time to physician
time frame: One day
description: Time to be seen by emergency physician after triage (mins, secs) on study days.
measure: Patient refusals
time frame: One day
description: Reasons for patient vaccination refusal
measure: Nursing satisfaction
time frame: One day
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
measure: Additional vaccine received
time frame: One day
description: Additional vaccines administered in the Public Health referral arm
measure: Triage time
time frame: One day
description: Time (in seconds) required to triage eligible patients in the emergency department
arm group label: Emergency Department vaccination group
arm group type: Experimental
description: Pertussis (Tdap) vaccine offered/administered in the Emergency Department
arm group label: Public Health referral group
arm group type: Experimental
description: Public Health referral for Pertussis (Tdap) vaccine administration offered
intervention type: Behavioral
intervention name: Tdap
description: Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine
arm group label: Emergency Department vaccination group
arm group label: Public Health referral group
other name: Boostrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Sibley, MD
role: Principal Investigator
affiliation: University of Prince Edward Island
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Whooping Cough
mesh term: Emergencies
sharing ipd: No