Immunisation Anxiety Related ReactionNCT03948633
Feasibility of Implementation of CARD for School-Based Immunizations
A study testing Multi-faceted knowledge translation intervention in people with Immunisation Anxiety Related Reaction, run by University of Toronto at 1 site in Canada.
Trial summary
A multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - was developed to improve the vaccination experience of students at school. CARD is a framework for delivering vaccinations that is student-centred that promotes coping. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunisation Anxiety Related Reaction
- 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
- 260 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2019to 31 Aug 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- grade 9 student 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 program
- 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, 1 recruiting
- Recruiting
Alberta Health Services Public Health - Calgary Zone
Calgary, Alberta, T2W 3N2
Joanne Coldham, MEd, 403 943-1197, joanne.coldham@ahs.ca
About this study
Official title: Improving the Vaccination Experience at School in Calgary
A multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - was developed to improve the vaccination experience of students at school. CARD is a framework for delivering vaccinations that is student-centred that promotes coping. This study will examine the feasibility of CARD implementation procedures and measures in the school vaccination program in Calgary, Alberta for use in a larger cluster trial.
Read the detailed description
Vaccination is estimated to have saved more lives in Canada over the last 50 years than any other single intervention and is considered one of the most important advances in the prevention of disease. One major drawback of vaccination, however, is that the usual route of administration involves a painful needle injection. In students undergoing school-based mass vaccinations, vaccine injections frequently cause sever distress and fainting, with some serious injuries resulting from fainting. Concerns about pain and/or needle fear are also directly responsible for vaccine refusal in this population.
An evidence based clinical practice guideline for mitigating vaccine injection pain, fear and fainting has been developed, however, it is not yet implemented across different school-based vaccination settings and students are not benefiting from the research evidence. In a prior small-scale project, investigators developed and implemented a multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - in some schools in a small public health region in Niagara, Ontario. CARD is a framework for delivering vaccinations that is student-centred and promotes coping. It integrates recommendations from the guideline in two separate components of the vaccination delivery program: 1) pre-vaccination day preparation, and 2) vaccination day activities. Investigators found preliminary evidence of acceptability, appropriateness, satisfaction and clinical effectiveness of CARD when used in grade 7 students in Niagara.
In this study, investigators plan to determine the feasibility of implementing CARD in a diverse and more complex public health region in Calgary, Alberta. Specifically, investigators will determine recruitment rates, adherence to CARD protocol, response rates for questionnaires, acceptability, appropriateness (fit), and satisfaction. The results will inform a future cluster trial.
- Conditions
- Immunisation Anxiety Related Reaction
- Being tested
- Multi-faceted knowledge translation intervention
- Keywords
- school vaccinations, pain management, knowledge translation
- 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 | 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.
percent complete data for student symptom survey
proportion of students that fill in questionnaire about their symptoms (fear, dizziness, pain) during vaccination
Measured: within 5 minutes after vaccination
Secondary outcomes (5)
percent complete data for nurse feedback form
proportion of immunizers that fill in questionnaire about interventions used during immunization (e.g., privacy, distraction)
Measured: within 5 minutes after vaccination
percent of schools recruited
proportion of schools that participate in the study
Measured: within 1 week of school vaccination clinic
percent compliance with CARD (intervention)
proportion of adherence to components of CARD protocol as assessed by CARD implementers using a self-reported 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
perceived quality of CARD (intervention) program delivery
perceptions of quality of CARD program delivery as reported by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual quality 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, as well as focus groups with other stakeholder groups (secondary targets - school staff, students, parents).
Measured: within 3 months after vaccination
perceived acceptability of CARD (intervention)
perception of acceptability (satisfaction with CARD) by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual acceptability 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, as well as focus groups with other stakeholder groups (secondary targets - school staff, students, parents).
Measured: within 3 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start25 Apr 2019
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
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 Immunisation Anxiety Related 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a feasibility study including 2 community health centres that have been randomly selected to either the multi-faceted knowledge translation intervention (CARD) or control (standard care) out of 8 community health centres anticipated to participate in a future cluster trial. Within each community health centre, 5 individual schools will be randomly selected to participate.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
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
- NCT03948633
- Sponsor's protocol ID
- 36893
- Status last verified
- May 2019
- First submitted
- 24 Apr 2019
- Last updated
- 28 May 2019
- 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
Publications
Taddio A, Coldham J, Logeman C, McMurtry CM, Little C, Samborn T, Bucci LM, MacDonald NE, Shah V, Dribnenki C, Snider J, Stephens D. Feasibility of implementation of CARD for school-based immunizations in Calgary, Alberta: a cluster trial. BMC Public Health. 2021 Feb 1;21(1):260. doi: 10.1186/s12889-021-10247-4.
PubMed 33526030
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Vaccination Experience at School in Calgary
- ClinicalTrials.gov ID
- NCT03948633
- Acronym / sponsor ID
- 36893
- Conditions
- Immunisation Anxiety Related Reaction
- Keywords
- school vaccinations, pain management, knowledge translation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 14 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.
A multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - was developed to improve the vaccination experience of students at school. CARD is a framework for delivering vaccinations that is student-centred that promotes coping. This study will examine the feasibility of CARD implementation procedures and measures in the school vaccination program in Calgary, Alberta for use in a larger cluster trial.
Detailed description
Vaccination is estimated to have saved more lives in Canada over the last 50 years than any other single intervention and is considered one of the most important advances in the prevention of disease. One major drawback of vaccination, however, is that the usual route of administration involves a painful needle injection. In students undergoing school-based mass vaccinations, vaccine injections frequently cause sever distress and fainting, with some serious injuries resulting from fainting. Concerns about pain and/or needle fear are also directly responsible for vaccine refusal in this population.
An evidence based clinical practice guideline for mitigating vaccine injection pain, fear and fainting has been developed, however, it is not yet implemented across different school-based vaccination settings and students are not benefiting from the research evidence. In a prior small-scale project, investigators developed and implemented a multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - in some schools in a small public health region in Niagara, Ontario. CARD is a framework for delivering vaccinations that is student-centred and promotes coping. It integrates recommendations from the guideline in two separate components of the vaccination delivery program: 1) pre-vaccination day preparation, and 2) vaccination day activities. Investigators found preliminary evidence of acceptability, appropriateness, satisfaction and clinical effectiveness of CARD when used in grade 7 students in Niagara.
In this study, investigators plan to determine the feasibility of implementing CARD in a diverse and more complex public health region in Calgary, Alberta. Specifically, investigators will determine recruitment rates, adherence to CARD protocol, response rates for questionnaires, acceptability, appropriateness (fit), and satisfaction. The results will inform a future cluster trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a feasibility study including 2 community health centres that have been randomly selected to either the multi-faceted knowledge translation intervention (CARD) or control (standard care) out of 8 community health centres anticipated to participate in a future cluster trial. Within each community health centre, 5 individual schools will be randomly selected to participate.
| 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 | 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
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- grade 9 student 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 program
- 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
percent complete data for student symptom survey
Time frame: within 5 minutes after vaccination
proportion of students that fill in questionnaire about their symptoms (fear, dizziness, pain) during vaccination
5 secondary outcomes
percent complete data for nurse feedback form
Time frame: within 5 minutes after vaccination
percent of schools recruited
Time frame: within 1 week of school vaccination clinic
percent compliance with CARD (intervention)
Time frame: within 3 months after vaccination
perceived quality of CARD (intervention) program delivery
Time frame: within 3 months after vaccination
perceived acceptability of CARD (intervention)
Time frame: within 3 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Derived from this study: PubMed 33526030Taddio A, Coldham J, Logeman C, McMurtry CM, Little C, Samborn T, Bucci LM, MacDonald NE, Shah V, Dribnenki C, Snider J, Stephens D. Feasibility of implementation of CARD for school-based immunizations in Calgary, Alberta: a cluster trial. BMC Public Health. 2021 Feb 1;21(1):260. doi: 10.1186/s12889-021-10247-4.
- Individual participant dataSharing planned: No. There is no plan to share IPD
Related trials for Immunisation Anxiety Related Reaction
Not yet recruiting
Media Orientation to Improve Childhood Vaccine Uptake and Address Parent and Caregivers Vaccine-related Anxiety: A Pilot Study
Anxiety, Vaccination Hesitancy
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 Immunisation Anxiety Related 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: status not confirmed, as of the sponsor's last update on 28 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Taddio, PhD (416-978-8822, anna.taddio@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent complete data for student symptom survey (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 NCT03948633, 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 28 May 2019.