Effectiveness of an Intervention on Vaccine Hesitancy Among Pediatric Nurses and Pediatricians

NCT06489236 | Completed

• 1 other identifier: PI21/01710
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Vaccination Hesitancy; Pediatric ALL; Presumptive Communication; Motivational Interviewing

Outcome Measures

Primary Outcomes (3)

• Self-perceived preparedness to handle vaccination concerns during pediatric consultations

  Pediatric nurses and pediatricians will complete both a baseline and post-intervention questionnaire. The outcome, "Self-perceived preparedness to handle vaccination concerns during pediatric consultations," will be evaluated using the following question: "I feel sufficiently trained to address vaccination concerns that families may raise," measured on a five-point Likert scale ranging from "strongly disagree" to "strongly agree".

  Baseline and 5 months later

• Presenting vaccination as a default behavior using presumptive communication

  Pediatric nurses and pediatricians will complete both a baseline and post-intervention questionnaire. The outcome, " Presenting vaccination as a default behavior using presumptive communication," will be evaluated using the following question: " I will start the vaccination conversation assuming the child will get vaccinated," measured on a five-point Likert scale ranging from "yes, always" to "never".

  Baseline and 5 months later

• Explicitly recommending vaccination to vaccine hesitant families

  Pediatric nurses and pediatricians will complete both a baseline and post-intervention questionnaire. The outcome, " Explicitly recommending vaccination to vaccine hesitant families," will be evaluated using the following question: " I will recommend getting vaccinated during that same visit" measured on a five-point Likert scale ranging from "yes, always" to "never".

  Baseline and 5 months later

Study Arms (2)

Vaccination promotion training program

EXPERIMENTAL

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.

Behavioral: Vaccine Confidence: Skills to Promote Vaccination in the Pediatric Consultations

Practice as usual

NO INTERVENTION

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.

Interventions

Vaccine Confidence: Skills to Promote Vaccination in the Pediatric Consultations BEHAVIORAL

Intervention mapping principles guided a multidisciplinary team through the development of the intervention. The intervention is a 12-hour training program focused on improving vaccination promotion and vaccine hesitancy management during pediatric consultations. The program comprises 10 hours of online education and 2 hours of in-person activities. Online training materials (short video lectures, video case studies, and readings) were structured in three learning modules covering vaccine and vaccine hesitancy technical information, vaccination promotion communication strategies, and practice organizational resources. In-person activities involved role-playings and group discussions. Intervention content is evidence-based. As a participation incentive, pediatric nurses and pediatricians who complete all program activities, including a multiple-choice final test, will receive 2,5 accredited continuing medical education credits.

Vaccination promotion training program

Eligibility Criteria

• Age: Up to 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric nurses
• Pediatricians
• Employed in public primary care centers in Barcelona city and Central Catalonia

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Public Health Agency of Barcelona: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Agència de Salut Pública de Barcelona (ASPB)

Barcelona, 08023, Spain

Location

Related Publications (19)

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• MacDonald 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.

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• Scalia 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.

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• Limaye 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 BACKGROUND

• Opel 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.

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• Chamberlain AT, Limaye RJ, O'Leary ST, Frew PM, Brewer SE, Spina CI, Ellingson MK, Dudley MZ, Orenstein WA, Donnelly MA, Riley LE, Ault KA, Salmon DA, Omer SB. Development and acceptability of a video-based vaccine promotion tutorial for obstetric care providers. Vaccine. 2019 May 1;37(19):2532-2536. doi: 10.1016/j.vaccine.2019.03.005. Epub 2019 Apr 5.

  PMID: 30962093 BACKGROUND

• Brewer NT. What Works to Increase Vaccination Uptake. Acad Pediatr. 2021 May-Jun;21(4S):S9-S16. doi: 10.1016/j.acap.2021.01.017.

  PMID: 33958099 BACKGROUND

• Lip A, Pateman M, Fullerton MM, Chen HM, Bailey L, Houle S, Davidson S, Constantinescu C. Vaccine hesitancy educational tools for healthcare providers and trainees: A scoping review. Vaccine. 2023 Jan 4;41(1):23-35. doi: 10.1016/j.vaccine.2022.09.093. Epub 2022 Nov 24.

  PMID: 36437208 BACKGROUND

• Jamison KC, Ahmed AH, Spoerner DA, Kinney D. Best shot: A motivational interviewing approach to address vaccine hesitancy in pediatric outpatient settings. J Pediatr Nurs. 2022 Nov-Dec;67:124-131. doi: 10.1016/j.pedn.2022.08.012. Epub 2022 Sep 13.

  PMID: 36108393 BACKGROUND

• Gagneur A, Bergeron J, Gosselin V, Farrands A, Baron G. A complementary approach to the vaccination promotion continuum: An immunization-specific motivational-interview training for nurses. Vaccine. 2019 May 6;37(20):2748-2756. doi: 10.1016/j.vaccine.2019.03.076. Epub 2019 Apr 3.

  PMID: 30954309 BACKGROUND

• Reno JE, Thomas J, Pyrzanowski J, Lockhart S, O'Leary ST, Campagna EJ, Dempsey AF. Examining strategies for improving healthcare providers' communication about adolescent HPV vaccination: evaluation of secondary outcomes in a randomized controlled trial. Hum Vaccin Immunother. 2019;15(7-8):1592-1598. doi: 10.1080/21645515.2018.1547607. Epub 2019 Jan 16.

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• Uthoff SAK, Zinkevich A, Franiel D, Below M, Splieth H, Iwen J, Biedermann M, Heinemeier D, Ansmann L. A complex intervention on vaccination uptake among older adults (>/= 60 years) in Germany - a study protocol with a mixed methods design. BMC Prim Care. 2023 Jul 15;24(1):148. doi: 10.1186/s12875-023-02101-w.

  PMID: 37452283 BACKGROUND

• Jarrett C, Wilson R, O'Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing vaccine hesitancy - A systematic review. Vaccine. 2015 Aug 14;33(34):4180-90. doi: 10.1016/j.vaccine.2015.04.040. Epub 2015 Apr 18.

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• Opel DJ, Robinson JD, Spielvogle H, Spina C, Garrett K, Dempsey AF, Perreira C, Dickinson M, Zhou C, Pahud B, Taylor JA, O'Leary ST. 'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention. BMJ Open. 2020 Aug 11;10(8):e039299. doi: 10.1136/bmjopen-2020-039299.

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• Elizondo-Alzola U, G Carrasco M, Pinos L, Picchio CA, Rius C, Diez E. Vaccine hesitancy among paediatric nurses: Prevalence and associated factors. PLoS One. 2021 May 19;16(5):e0251735. doi: 10.1371/journal.pone.0251735. eCollection 2021.

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• Picchio CA, Carrasco MG, Sague-Vilavella M, Rius C. Knowledge, attitudes and beliefs about vaccination in primary healthcare workers involved in the administration of systematic childhood vaccines, Barcelona, 2016/17. Euro Surveill. 2019 Feb;24(6):1800117. doi: 10.2807/1560-7917.ES.2019.24.6.1800117.

  PMID: 30755298 BACKGROUND

• Roel E, Henderson E, Valmayor S, Porthe V, Asensio A, Ramirez-Morros A, Bruna X, Pasarin MI, Rius C, Diez E; CONFIVAC Research Group. Effectiveness of CONFIVAC, an intervention to enhance paediatric nurses and paediatricians skills to promote vaccination: A mixed-methods cluster randomized trial. Vaccine. 2025 Aug 30;62:127603. doi: 10.1016/j.vaccine.2025.127603. Epub 2025 Aug 15.

  PMID: 40818260 DERIVED

Related Links

• Book: Qualitative Research \& Evaluation Methods
• Book: Designing and Conducting Mixed Methods Research
• BooK: Planning Health Promotion Programs: An Intervention Mapping Approach, 4th Edition

MeSH Terms

Conditions

Vaccination Hesitancy; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elena Roel Herranz

  Public Health Agency of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Public primary care center pediatric teams in Barcelona city and Central Catalonia that enroll in the study will be randomly allocated into two parallel groups: intervention and control groups. This allocation will be conducted through a web-based procedure by block design. Pediatric teams will be paired based on the assigned population under 14 years old, the socioeconomic status of the basic health area, immunization coverage, and location, using data from the Primary Care Services Information System (SISAP). Team names will be blinded throughout the randomization process. Once randomization is complete, allocation will be unblinded to the research team. The control group will follow the standard procedures for vaccination promotion and vaccine hesitancy management. Pediatric teams in the control group will be offered the intervention once it has been evaluated.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 5, 2024
• Study Start: October 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)