Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial.
Children
Immunization stress-related responses
Pain management
Randomized controlled trial
School vaccinations
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
26 04 2022
26 04 2022
Historique:
received:
14
01
2022
revised:
17
02
2022
accepted:
20
02
2022
pubmed:
3
4
2022
medline:
19
4
2022
entrez:
2
4
2022
Statut:
ppublish
Résumé
The CARD (Comfort Ask Relax Distract) system is a vaccine delivery framework that integrates evidence-based interventions to reduce stress-related responses and improve the vaccination experience for children undergoing vaccinations at school. In preliminary studies, CARD was acceptable and effective. The objective was to evaluate CARD in a large, pragmatic trial to confirm its effectiveness in real-world settings. Hybrid effectiveness-implementation cluster randomized trial in schools receiving vaccination services from Wellington-Dufferin-Guelph Public Health. Forty schools with grade 7 students (12 years old) were randomized to CARD and control (n = 20/group). Nurses in CARD schools planned clinics with principals and educated students about CARD ahead of time. Principals disseminated information to staff and parents and sent reminders. Vaccination day processes minimized fear and facilitated student self-selected coping strategies. Nurses in control schools followed usual practices, which excluded principal meetings, education, reminders, and systematic integration of fear-reducing or child-selected coping strategies. Outcomes included stress-related symptoms (fear - primary outcome, pain, dizziness, fainting, post-vaccination reactions), use of coping interventions, vaccination uptake, attitudes and implementation outcomes (acceptability, appropriateness, feasibility, fidelity). Altogether, 1919 students were included. Fear and pain were lower in CARD schools: OR 0.65 (95% CI 0.47-0.90) and OR 0.62 (95% CI 0.50-0.77), respectively. No students fainted in CARD schools compared to 0.8% in control (p = 0.02). Dizziness and post-vaccination reactions did not differ. Student-led coping interventions were used more frequently in CARD schools. Vaccination uptake was 76.1% in CARD schools and 72.5% in control schools (OR 1.13 (95% CI 0.85-1.50)). Staff and students had positive attitudes about CARD and implementation outcomes; however, recommendations were made to improve fidelity. CARD reduced stress-related responses in students undergoing vaccinations at school and was positively received by students and public health staff. CARD is recommended to improve the quality of vaccination delivery services. NCT03966300.
Sections du résumé
BACKGROUND
The CARD (Comfort Ask Relax Distract) system is a vaccine delivery framework that integrates evidence-based interventions to reduce stress-related responses and improve the vaccination experience for children undergoing vaccinations at school. In preliminary studies, CARD was acceptable and effective. The objective was to evaluate CARD in a large, pragmatic trial to confirm its effectiveness in real-world settings.
METHODS
Hybrid effectiveness-implementation cluster randomized trial in schools receiving vaccination services from Wellington-Dufferin-Guelph Public Health. Forty schools with grade 7 students (12 years old) were randomized to CARD and control (n = 20/group). Nurses in CARD schools planned clinics with principals and educated students about CARD ahead of time. Principals disseminated information to staff and parents and sent reminders. Vaccination day processes minimized fear and facilitated student self-selected coping strategies. Nurses in control schools followed usual practices, which excluded principal meetings, education, reminders, and systematic integration of fear-reducing or child-selected coping strategies. Outcomes included stress-related symptoms (fear - primary outcome, pain, dizziness, fainting, post-vaccination reactions), use of coping interventions, vaccination uptake, attitudes and implementation outcomes (acceptability, appropriateness, feasibility, fidelity).
RESULTS
Altogether, 1919 students were included. Fear and pain were lower in CARD schools: OR 0.65 (95% CI 0.47-0.90) and OR 0.62 (95% CI 0.50-0.77), respectively. No students fainted in CARD schools compared to 0.8% in control (p = 0.02). Dizziness and post-vaccination reactions did not differ. Student-led coping interventions were used more frequently in CARD schools. Vaccination uptake was 76.1% in CARD schools and 72.5% in control schools (OR 1.13 (95% CI 0.85-1.50)). Staff and students had positive attitudes about CARD and implementation outcomes; however, recommendations were made to improve fidelity.
DISCUSSION
CARD reduced stress-related responses in students undergoing vaccinations at school and was positively received by students and public health staff. CARD is recommended to improve the quality of vaccination delivery services.
TRIAL REGISTRATION
NCT03966300.
Identifiants
pubmed: 35365344
pii: S0264-410X(22)00224-9
doi: 10.1016/j.vaccine.2022.02.069
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03966300']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2802-2809Subventions
Organisme : CIHR
ID : FRN 159905
Pays : Canada
Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: A. Taddio reports a University of Toronto Section 9 Trademark No. 924835 for CARD™. LMB reports that Immunize Canada received grants from Pfizer Inc., Merck Canada, Sanofi Pasteur, Seqiris, and Glaxo-Smith-Kline unrelated to this work. The other authors declare they have no competing interests.