Vaccine Adverse ReactionNCT03966300
Improving the School Vaccination Experience: What CARDs Are You Going to Play?
A study testing Multi-faceted knowledge translation intervention in people with Vaccine Adverse Reaction and Vaccination; Complications, run by University of Toronto at 1 site in Canada.
Trial summary
Vaccination hesitancy is identified as a threat to global health by the World Health Organization (WHO). For adolescents undergoing vaccination at school, prior studies demonstrate that concerns about pain and/or fear of needles contribute to negative experiences with vaccination and non-compliance with vaccination. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction, Vaccination; Complications, 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
- 1,919 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2019to 22 Nov 2019
- 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 7 students eligible for vaccination at school
- public health staff working in the school vaccination program
Who cannot join
- unable to understand and read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial
Vaccination hesitancy is identified as a threat to global health by the World Health Organization (WHO). For adolescents undergoing vaccination at school, prior studies demonstrate that concerns about pain and/or fear of needles contribute to negative experiences with vaccination and non-compliance with vaccination. The investigators developed an intervention that addresses vaccination hesitancy. In this study, investigators will evaluate the effectiveness of this intervention in a randomized controlled trial.
Read the detailed description
Vaccination hesitancy is identified by the World Health Organization (WHO) as one of ten threats to global health. The WHO's 3C model of vaccination hesitancy identifies 3 domains of vaccine hesitancy: 1) Confidence (trust in health care providers), 2) Complacency (perceived importance of vaccine-preventable disease) and 3) Convenience (improving clinic processes). The investigators developed a multifaceted knowledge translation intervention that addresses vaccination hesitancy in school-based vaccinations. The intervention is called The CARD(TM) System (C-Comfort, A-Ask, R-Relax, D-Distract). CARD is a framework for delivering vaccinations that is student-centred and promotes coping. CARD integrates evidence-based interventions related to planning and execution of school vaccination clinics to directly tackle all 3 domains of vaccination hesitancy. It tackles Confidence by improving pain/fear management (it teaches students and public health staff how to reduce student symptoms which improves the vaccination experience and improves student trust in health care providers). It tackles Complacency by educating students about what vaccines are, why they are needed, community immunity, as well as the specific diseases they are being protected against. It tackles Convenience by improving school-based clinic processes by integrating student preferences (e.g., privacy, having a support person present).
In this randomized controlled trial, the investigators will evaluate the impact of CARD (vs. usual care) on student important outcomes and process outcomes.
- Conditions
- Vaccine Adverse Reaction, Vaccination; Complications, Fear
- Being tested
- Multi-faceted knowledge translation intervention
- Keywords
- school vaccinations, pain management, vaccination hesitancy, knowledge translation
- Medical subject headings
- Agnosia, Vaccination Hesitancy
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/usual 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 (13)
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 of 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 of 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
Measured: within 3 months of vaccination clinics
Knowledge of effective coping strategies
knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test, administered to implementers
Measured: within 3 months after vaccination clinics
Perceptions about pain and fear
perceptions about pain and fear, as assessed using a 5-point likert scale (higher number represents better outcome) for implementers
Measured: within 3 months of vaccination clinics
Perceptions about vaccination program
perceptions about vaccination program, as assessed using the Vaccination Program Global Impresssion Checklist, individual questions (5-point likert scale, higher number represents better outcome) for implementers
Measured: within 3 months of vaccination clinics
Willingness to be vaccinated
student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)
Measured: within 5 minutes after vaccination
Satisfaction with CARD
student self-reported satisfaction with CARD, as assessed using Student Feedback Survey, individual questions (5-point likert scale, higher number indicates better outcome)
Measured: within 5 minutes after vaccination
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 start19 Sep 2019
- Primary completion20 Nov 2019
- Study completion22 Nov 2019
Why it stopped: Study was terminated due to inability to: 1) vaccinate at school, 2) control and track vaccinations, 3) continue the intervention as proposed. Data collected during fall 2019 clinics are being transferred to researchers and verified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Randomized controlled trial; schools will be randomized to CARD or usual care and all students attending the schools will receive the allocated treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,919 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- 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
- NCT03966300
- Sponsor's protocol ID
- 37598
- Status last verified
- Jun 2021
- First submitted
- 25 May 2019
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Taddio A, Gudzak V, Jantzi M, Logeman C, Bucci LM, MacDonald NE, Moineddin R. Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial. Vaccine. 2022 Apr 26;40(19):2802-2809. doi: 10.1016/j.vaccine.2022.02.069. Epub 2022 Mar 29.
PubMed 35365344
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03966300
- Acronym / sponsor ID
- 37598
- Conditions
- Vaccine Adverse Reaction, Vaccination; Complications, Fear
- Keywords
- school vaccinations, pain management, vaccination hesitancy, knowledge translation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to inability to: 1) vaccinate at school, 2) control and track vaccinations, 3) continue the intervention as proposed. Data collected during fall 2019 clinics are being transferred to researchers and verified.
- Enrolment
- 1,919 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (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 hesitancy is identified as a threat to global health by the World Health Organization (WHO). For adolescents undergoing vaccination at school, prior studies demonstrate that concerns about pain and/or fear of needles contribute to negative experiences with vaccination and non-compliance with vaccination. The investigators developed an intervention that addresses vaccination hesitancy. In this study, investigators will evaluate the effectiveness of this intervention in a randomized controlled trial.
Detailed description
Vaccination hesitancy is identified by the World Health Organization (WHO) as one of ten threats to global health. The WHO's 3C model of vaccination hesitancy identifies 3 domains of vaccine hesitancy: 1) Confidence (trust in health care providers), 2) Complacency (perceived importance of vaccine-preventable disease) and 3) Convenience (improving clinic processes). The investigators developed a multifaceted knowledge translation intervention that addresses vaccination hesitancy in school-based vaccinations. The intervention is called The CARD(TM) System (C-Comfort, A-Ask, R-Relax, D-Distract). CARD is a framework for delivering vaccinations that is student-centred and promotes coping. CARD integrates evidence-based interventions related to planning and execution of school vaccination clinics to directly tackle all 3 domains of vaccination hesitancy. It tackles Confidence by improving pain/fear management (it teaches students and public health staff how to reduce student symptoms which improves the vaccination experience and improves student trust in health care providers). It tackles Complacency by educating students about what vaccines are, why they are needed, community immunity, as well as the specific diseases they are being protected against. It tackles Convenience by improving school-based clinic processes by integrating student preferences (e.g., privacy, having a support person present).
In this randomized controlled trial, the investigators will evaluate the impact of CARD (vs. usual care) on student important outcomes and process outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial; schools will be randomized to CARD or usual care and all students attending the schools will receive the allocated treatment
| 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/usual 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 (2 listed)
- grade 7 students eligible for vaccination at school
- public health staff working in the school vaccination program
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
13 secondary outcomes
Student pain
Time frame: within 5 minutes after vaccination
Student dizziness
Time frame: within 5 minutes of 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 of vaccination clinics
Compliance with CARD
Time frame: within 3 months of vaccination clinics
Knowledge of effective coping strategies
Time frame: within 3 months after vaccination clinics
Perceptions about pain and fear
Time frame: within 3 months of vaccination clinics
Perceptions about vaccination program
Time frame: within 3 months of vaccination clinics
Willingness to be vaccinated
Time frame: within 5 minutes after vaccination
Satisfaction with CARD
Time frame: within 5 minutes after vaccination
Results and safety
The study was stopped early (reason given: Study was terminated due to inability to: 1) vaccinate at school, 2) control and track vaccinations, 3) continue the intervention as proposed. Data collected during fall 2019 clinics are being transferred to researchers and verified.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Derived from this study: PubMed 35365344Taddio A, Gudzak V, Jantzi M, Logeman C, Bucci LM, MacDonald NE, Moineddin R. Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial. Vaccine. 2022 Apr 26;40(19):2802-2809. doi: 10.1016/j.vaccine.2022.02.069. Epub 2022 Mar 29.
- Individual participant dataSharing planned: No. 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 Vaccine Adverse Reaction and Vaccination; Complications, 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 2 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: stopped early, as of the sponsor's last update on 29 Jun 2021. 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 was stopped early (reason given: Study was terminated due to inability to: 1) vaccinate at school, 2) control and track vaccinations, 3) continue the intervention as proposed. Data collected during fall 2019 clinics are being transferred to researchers and verified.). Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT03966300, which also lists 1 linked publication.
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 29 Jun 2021.