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出境医 / 临床实验 / Improving the School Vaccination Experience: What CARDs Are You Going to Play?
Improving the School Vaccination Experience: What CARDs Are You Going to Play?
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vaccine Adverse Reaction Vaccination; Complications Fear | Other: Multi-faceted knowledge translation intervention | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Participant) |
| Masking Description: | Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained will not deliver care to participants in the intervention group |
| Primary Purpose: | Treatment |
| Official Title: | Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial |
| Actual Study Start Date : | June 12, 2019 |
| Estimated Primary Completion Date : | June 2020 |
| Estimated Study Completion Date : | August 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: CARD (multi-faceted knowledge translation intervention)
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)
|
Other: Multi-faceted knowledge translation intervention
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Other Name: CARD
|
|
No Intervention: Control (standard/usual care)
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)
|
Outcome Measures
Primary Outcome Measures :
- Student fear [ Time Frame: within 5 minutes after vaccination ]student self-reported fear during vaccination, rated on a 0-10 scale
Secondary Outcome Measures :
- Student pain [ Time Frame: within 5 minutes after vaccination ]student self-reported pain during vaccination, rated on a 0-10 scale
- Student dizziness [ Time Frame: within 5 minutes of vaccination ]student self-reported dizziness during vaccination, rated on a 0-10 scale
- Student fainting [ Time Frame: within 1 hour after vaccination ]student fainting during vaccination, yes/no, as assessed by immunizer
- Student post-immunization stress-related responses [ Time Frame: within 1 hour after vaccination ]student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO immunization Stress Responses Criteria
- Utilization of coping strategies [ Time Frame: within 5 minutes after vaccination ]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
- Uptake of vaccination [ Time Frame: by end of school year ]proportion of students vaccinated (overall and for each vaccine)
- Implementation success of CARD [ Time Frame: within 3 months of vaccination clinics ]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
- Compliance with CARD [ Time Frame: within 3 months of vaccination clinics ]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
- Knowledge of effective coping strategies [ Time Frame: within 3 months after vaccination clinics ]knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test, administered to implementers
- Perceptions about pain and fear [ Time Frame: within 3 months of vaccination clinics ]perceptions about pain and fear, as assessed using a 5-point likert scale (higher number represents better outcome) for implementers
- Perceptions about vaccination program [ Time Frame: within 3 months of vaccination clinics ]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
- Willingness to be vaccinated [ Time Frame: within 5 minutes after vaccination ]student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)
- Satisfaction with CARD [ Time Frame: within 5 minutes after vaccination ]student self-reported satisfaction with CARD, as assessed using Student Feedback Survey, individual questions (5-point likert scale, higher number indicates better outcome)
Eligibility Criteria
| Ages Eligible for Study: | 11 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- grade 7 students eligible for vaccination at school
- public health staff working in the school vaccination program
Exclusion Criteria:
- unable to understand and read English
Contacts and Locations
Locations
| Canada, Ontario | |
| Wellington Dufferin Guelph Public Health | |
| Guelph, Ontario, Canada, L9W 1K3 | |
Sponsors and Collaborators
University of Toronto
Investigators
| Principal Investigator: | Anna Taddio, PhD | University of Toronto |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 25, 2019 | ||||
| First Posted Date ICMJE | May 29, 2019 | ||||
| Last Update Posted Date | June 12, 2020 | ||||
| Actual Study Start Date ICMJE | June 12, 2019 | ||||
| Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Student fear [ Time Frame: within 5 minutes after vaccination ] student self-reported fear during vaccination, rated on a 0-10 scale
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving the School Vaccination Experience: What CARDs Are You Going to Play? | ||||
| Official Title ICMJE | Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial | ||||
| Brief 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. 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Participant)Masking Description: Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained will not deliver care to participants in the intervention group Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE | Other: Multi-faceted knowledge translation intervention
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Other Name: CARD
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE |
1400 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | August 2020 | ||||
| Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 11 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03966300 | ||||
| Other Study ID Numbers ICMJE | 37598 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Anna Taddio, University of Toronto | ||||
| Study Sponsor ICMJE | University of Toronto | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Toronto | ||||
| Verification Date | June 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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