Vaccination; ComplicationsNCT03966391
Effectiveness of CARD for Improving School-Based Immunizations
A study testing Multi-faceted knowledge translation intervention in people with Vaccination; Complications and Vaccine Adverse Reaction, run by University of Toronto at 1 site in Canada.
Trial summary
Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Complications, Vaccine Adverse Reaction, Fear
- What is being tested?
- Multi-faceted knowledge translation intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,839 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2019to 12 Mar 2020
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- grade 6 and 9 students eligible for vaccination at school
- public health staff in community health centre involved in the study
- school staff in a participating school involved in school vaccination
- parent of a student eligible for vaccination at school
Who cannot join
- unable to understand and read English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Health Services Public Health - Calgary Zone
Calgary, Alberta, T2W 3N2
About this study
Official title: Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial
Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.
Read the detailed description
The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation.
Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.
- Conditions
- Vaccination; Complications, Vaccine Adverse Reaction, Fear
- Being tested
- Multi-faceted knowledge translation intervention
- Keywords
- school vaccinations, pain management, knowledge translation, cluster trial
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-faceted knowledge translation interventionOther
Also called CARD
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
| Study group | Role | What they receive |
|---|---|---|
| CARD (multi-faceted knowledge translation intervention) | Experimental | CARD will be integrated into the school vaccination program. This includes pre-vaccination day preparation (e.g., planning of clinic spaces, student and school staff education about CARD) and vaccination day activities (e.g., clinic set-up, processes for triaging students, implementing pain/ fear/fainting mitigation interventions from CARD during vaccination) Receives: Other: Multi-faceted knowledge translation intervention |
| Control (standard care) | No intervention | There are no specific procedures being undertaken to plan or execute clinics. Usual practices will be instituted (i.e., no education specific to CARD, nor clinic set-up or execution to incorporate interventions for pain, fear or fainting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student fear
student self-reported fear during vaccination, rated on a 0-10 scale
Measured: within 5 minutes after vaccination
Secondary outcomes (8)
Student pain
student self-reported pain during vaccination, rated on a 0-10 scale
Measured: within 5 minutes after vaccination
Student dizziness
student self-reported dizziness during vaccination, rated on a 0-10 scale
Measured: within 5 minutes after vaccination
Student fainting
student fainting during vaccination, yes/no, as assessed by immunizer
Measured: within 1 hour after vaccination
Student post-immunization stress-related responses
student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO Immunization Stress Responses Criteria
Measured: within 1 hour after vaccination
Utilization of coping strategies
use of individual coping strategies during vaccination (distraction, topical anesthetic, privacy, support person, deep breathing, muscle tension), yes/no, as assessed by immunizer using Documentation checklist
Measured: within 5 minutes after vaccination
Uptake of vaccination
proportion of students vaccinated (overall and for each vaccine)
Measured: by end of school year
Implementation success of CARD
perceptions of implementation success of CARD program delivery as reported by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual questions (5-point likert scale, higher number represents better outcome). This information will be supplemented with information from focus groups with implementers and study notes
Measured: within 3 months after vaccination clinics
Compliance with CARD
percent compliance with CARD implementation as assessed by implementers using a CARD compliance checklist. This information will be supplemented with information from focus groups with implementers and study notes, as well as focus groups with other stakeholder groups (students, parents, school staff).
Measured: within 3 months after vaccination clinics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start25 Sep 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8,839 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966391
- Sponsor's protocol ID
- 036893
- Status last verified
- Mar 2023
- First submitted
- 25 May 2019
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial
- ClinicalTrials.gov ID
- NCT03966391
- Acronym / sponsor ID
- 036893
- Conditions
- Vaccination; Complications, Vaccine Adverse Reaction, Fear
- Keywords
- school vaccinations, pain management, knowledge translation, cluster trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,839 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 29 May 2019 (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.
Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.
Detailed description
The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation.
Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included.
| Arm | Type | Receives |
|---|---|---|
| CARD (multi-faceted knowledge translation intervention) | Experimental | Other: Multi-faceted knowledge translation interventionCARD will be integrated into the school vaccination program. This includes pre-vaccination day preparation (e.g., planning of clinic spaces, student and school staff education about CARD) and vaccination day activities (e.g., clinic set-up, processes for triaging students, implementing pain/ fear/fainting mitigation interventions from CARD during vaccination) |
| Control (standard care) | No intervention | –There are no specific procedures being undertaken to plan or execute clinics. Usual practices will be instituted (i.e., no education specific to CARD, nor clinic set-up or execution to incorporate interventions for pain, fear or fainting) |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- grade 6 and 9 students eligible for vaccination at school
- public health staff in community health centre involved in the study
- school staff in a participating school involved in school vaccination
- parent of a student eligible for vaccination at school
Key exclusion criteria (1 listed)
- unable to understand and read English
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 |
|---|---|---|
| Multi-faceted knowledge translation interventionAlso: CARDThe intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program | Other | CARD (multi-faceted knowledge translation intervention) |
Primary outcome
Student fear
Time frame: within 5 minutes after vaccination
student self-reported fear during vaccination, rated on a 0-10 scale
8 secondary outcomes
Student pain
Time frame: within 5 minutes after vaccination
Student dizziness
Time frame: within 5 minutes after vaccination
Student fainting
Time frame: within 1 hour after vaccination
Student post-immunization stress-related responses
Time frame: within 1 hour after vaccination
Utilization of coping strategies
Time frame: within 5 minutes after vaccination
Uptake of vaccination
Time frame: by end of school year
Implementation success of CARD
Time frame: within 3 months after vaccination clinics
Compliance with CARD
Time frame: within 3 months after vaccination clinics
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 16 Mar 2023.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
Anna Taddio, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-faceted knowledge translation intervention in people with Vaccination; Complications and Vaccine Adverse Reaction, run by University of Toronto 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 4 inclusion and 1 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 16 Mar 2023. 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?
Student fear (time frame: within 5 minutes after vaccination). 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 16 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.