Clinical trial · Interventional
Effectiveness of an Intervention on Vaccine Hesitancy Among Pediatric Nurses and Pediatricians
Effectiveness of an Intervention on Vaccine Hesitancy Among Pediatric Nurses and Pediatricians: A Mixed Methods Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this cluster randomized controlled trial is to assess the effectiveness of a multicomponent intervention designed to improve pediatric nurses' and pediatricians' knowledge, self-efficacy, communication skills, and practice administrative procedures and policies for promoting vaccines in the child and adolescent immunization schedule and addressing patient vaccine hesitancy. The main research questions are: * Does the intervention meet pediatric nurses' and pediatricians' educational needs regarding vaccination? * Does the intervention increase the use of presumptive communication by pediatric nurses and pediatricians during vaccine conversations? * Does the intervention enhance the confidence of pediatric nurses and pediatricians to effectively navigate conversations with vaccine-hesitant families? * Does the intervention enhance the abilities of pediatric nurses and pediatricians to effectively navigate conversations with vaccine-hesitant families? Participants assigned to the intervention group will complete a 12-hour, medically accredited, evidence-based training program focused on vaccination promotion. This training will be divided into two components: 10 hours of online education covering vaccines and vaccination communication strategies, and 2 hours of in-person activities involving role-playing and group discussions. Pediatric nurses and pediatricians assigned to the control group will continue with their usual practices. To assess the effectiveness of the intervention formative and pre/post summative evaluations with a mixed-methods approach will be carried out.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Motivational Interviewing | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Presumptive Communication | — | UNRESOLVED | — |
| Vaccination Hesitancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaccine Confidence: Skills to Promote Vaccination in the Pediatric Consultations | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaccination promotion training program
- description
- Pediatric nurses and pediatricians enrolled in the study employed at public primary care centers in Barcelona city and Central Catalonia randomly allocated to the intervention group. Intervention administered: 12-hour, medically accredited, evidence-based training program focused on vaccination promotion.
- interventionNames
- Behavioral: Vaccine Confidence: Skills to Promote Vaccination in the Pediatric Consultations
- type
- NO_INTERVENTION
- label
- Practice as usual
- description
- Pediatric nurses and pediatricians enrolled in the study employed at public primary care centers in Barcelona city and Central Catalonia randomly allocated to the control group. No intervention administered. Practice as usual.
Primary outcomes (3)
- measure
- Self-perceived preparedness to handle vaccination concerns during pediatric consultations
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 67 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric nurses * Pediatricians * Employed in public primary care centers in Barcelona city and Central Catalonia Exclusion Criteria: * Other health care professionals * Not completing the study baseline questionnaire * Changing primary care centers during the intervention period * Not actively working for the entire duration of the intervention period (October 2023 to February 2024)
References
Publications (19)
- BACKGROUNDChan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. PMID 23303884
- BACKGROUNDde Figueiredo A, Simas C, Karafillakis E, Paterson P, Larson HJ. Mapping global trends in vaccine confidence and investigating barriers to vaccine uptake: a large-scale retrospective temporal modelling study. Lancet. 2020 Sep 26;396(10255):898-908. doi: 10.1016/S0140-6736(20)31558-0. Epub 2020 Sep 10. PMID 32919524
- BACKGROUNDMacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17. PMID 25896383
- BACKGROUNDScalia P, Durand MA, Elwyn G. Shared decision-making interventions: An overview and a meta-analysis of their impact on vaccine uptake. J Intern Med. 2022 Apr;291(4):408-425. doi: 10.1111/joim.13405. Epub 2021 Nov 26. PMID 34700363
- BACKGROUNDKok G, Gottlieb NH, Peters GJ, Mullen PD, Parcel GS, Ruiter RA, Fernandez ME, Markham C, Bartholomew LK. A taxonomy of behaviour change methods: an Intervention Mapping approach. Health Psychol Rev. 2016 Sep;10(3):297-312. doi: 10.1080/17437199.2015.1077155. Epub 2015 Oct 15. PMID 26262912
- BACKGROUNDLimaye RJ, Opel DJ, Dempsey A, Ellingson M, Spina C, Omer SB, Dudley MZ, Salmon DA, Leary SO. Communicating With Vaccine-Hesitant Parents: A Narrative Review. Acad Pediatr. 2021 May-Jun;21(4S):S24-S29. doi: 10.1016/j.acap.2021.01.018. PMID 33958087
- BACKGROUNDOpel DJ, Heritage J, Taylor JA, Mangione-Smith R, Salas HS, Devere V, Zhou C, Robinson JD. The architecture of provider-parent vaccine discussions at health supervision visits. Pediatrics. 2013 Dec;132(6):1037-46. doi: 10.1542/peds.2013-2037. Epub 2013 Nov 4.