PertussisNCT03304275
The Feasibility of Pertussis Immunization in a Canadian Emergency Department
A study testing Tdap in people with Pertussis, run by University of Prince Edward Island at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Tdap
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 644 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, PO Box 6600
About this study
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.
Read the detailed 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.
- Conditions
- Pertussis
- Being tested
- Tdap
- Keywords
- Pertussis, Vaccination, Emergency Department
- Medical subject headings
- Whooping Cough, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TdapBehavioural
Also called Boostrix
Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department vaccination group | Experimental | Pertussis (Tdap) vaccine offered/administered in the Emergency Department Receives: Behavioral: Tdap |
| Public Health referral group | Experimental | Public Health referral for Pertussis (Tdap) vaccine administration offered Receives: Behavioral: Tdap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of immunization
Rate of patients receiving Tdap vaccine
Measured: One day
Secondary outcomes (7)
Length of Stay
Length of Stay (mins, secs) for all patients presenting to the emergency. department on study days.
Measured: One day
Left with out being seen rate
Rate of patients leaving without being seen by a physician on study days.
Measured: One day
Time to physician
Time to be seen by emergency physician after triage (mins, secs) on study days.
Measured: One day
Patient refusals
Reasons for patient vaccination refusal
Measured: One day
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
Measured: One day
Additional vaccine received
Additional vaccines administered in the Public Health referral arm
Measured: One day
Triage time
Time (in seconds) required to triage eligible patients in the emergency department
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start10 Jul 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Responsible party
- Sponsor
- Investigators
- Aaron Sibley, MD, Principal investigator, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304275
- Sponsor's protocol ID
- 6007232
- Status last verified
- Jan 2018
- First submitted
- 25 Sep 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Pertussis Immunization in a Canadian Emergency Department
- ClinicalTrials.gov ID
- NCT03304275
- Acronym / sponsor ID
- 6007232
- Conditions
- Pertussis
- Keywords
- Pertussis, Vaccination, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Department vaccination group | Experimental | Behavioral: TdapPertussis (Tdap) vaccine offered/administered in the Emergency Department |
| Public Health referral group | Experimental | Behavioral: TdapPublic Health referral for Pertussis (Tdap) vaccine administration offered |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TdapAlso: BoostrixRandomized controlled trial of 2 strategies to provide adults with the Tdap vaccine | Behavioural | Emergency Department vaccination group, Public Health referral group |
Primary outcome
Rate of immunization
Time frame: One day
Rate of patients receiving Tdap vaccine
7 secondary outcomes
Length of Stay
Time frame: One day
Left with out being seen rate
Time frame: One day
Time to physician
Time frame: One day
Patient refusals
Time frame: One day
Nursing satisfaction
Time frame: One day
Additional vaccine received
Time frame: One day
Triage time
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Sibley, MD principal investigator
University of Prince Edward Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tdap in people with Pertussis, run by University of Prince Edward Island at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of immunization (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.