NCT03304275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
644

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

September 25, 2017

Last Update Submit

January 24, 2018

Conditions

Pertussis

Keywords

PertussisVaccinationEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Rate of immunization

    Rate of patients receiving Tdap vaccine

    One day

Secondary Outcomes (7)

  • Length of Stay

    One day

  • Left with out being seen rate

    One day

  • Time to physician

    One day

  • Patient refusals

    One day

  • Nursing satisfaction

    One day

  • +2 more secondary outcomes

Study Arms (2)

Emergency Department vaccination group

EXPERIMENTAL

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

Behavioral: Tdap

Public Health referral group

EXPERIMENTAL

Public Health referral for Pertussis (Tdap) vaccine administration offered

Behavioral: Tdap

Interventions

TdapBEHAVIORAL

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

Also known as: Boostrix
Emergency Department vaccination groupPublic Health referral group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, PO Box 6600, Canada

Location

MeSH Terms

Conditions

Whooping CoughEmergencies

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aaron Sibley, MD

    University of Prince Edward Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 6, 2017

Study Start

July 10, 2017

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)