Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489236
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-14
Brief Title:
Effectiveness of an Intervention on Vaccine Hesitancy Among Pediatric Nurses and Pediatricians
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Effectiveness of an Intervention on Vaccine Hesitancy Among Pediatric Nurses and Pediatricians A Mixed Methods Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 prepost summative evaluations with a mixed-methods approach will be carried out
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 prepost summative evaluations with a mixed-methods approach will be carried out
Detailed Description:
BackgroundObjectivesHypothesis
How pediatric nurses and pediatricians PNP handle vaccination conversations can significantly influence vaccination decisions PNP who are at the frontline of administering childhood vaccinations may not be well-equipped to address vaccination doubts or concerns of parents or legal guardians A study conducted among PNP in primary care centers in Barcelona revealed that only 71 of professionals felt they had sufficient training information and resources to adequately respond to questions from vaccine-hesitant families This lack of preparedness was reported by 40 of nurses and 17 of pediatricians Additionally PNP also expressed a need for more information about vaccines in online 523 or through in-person training sessions 502
Intervention mapping IM is a theory- and evidenced-based iterative tool useful in the planning of health promotion interventions Using the IM framework the investigators developed a 12-hour training program to increase PNPs knowledge self-efficacy communication skills and organizational culture for 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 include short video lectures video case studies and readings In-person activities involve role-playings and group discussions The program was accredited by the Catalan Council for Continuing Education of Health Professions CCFCPS To incentivize participation providers completing all program activities including a multiple-choice final test will receive 25 accredited continuing medical education credits
Mixed-methods evaluations provide a more comprehensive and profound understanding of intervention effects and help identify areas for improvement This study aims to evaluate the effectiveness of an intervention on PNP psychosocial determinants knowledge beliefs attitudes and self-efficacy and behaviors in promoting vaccination and addressing vaccine hesitancy during pediatric consultations using quantitative and qualitative methods Specifically the investigators will assess PNPs satisfaction with the 12-hour training program and changes in their psychosocial determinants and vaccination behaviors
Methods
The investigators will employ a mixed-method approach for the evaluation of the intervention Quantitative and qualitative data will be integrated through triangulation principles Quantitative analysis will involve the design of a two-arm cluster randomized control trial For the qualitative evaluation the investigators plan to carry out a descriptive qualitative study with a phenomenological approach
Cluster Randomized Control Trial
Study design Two-arm parallel cluster randomized controlled trial during 5 months with pediatric care providers in public primary care centers in Barcelona city Catalonia Spain and Central Catalonia Catalonia Spain Intervention group will receive a 12-hour online and in-person training program for improving vaccination promotion and vaccine hesitancy management during pediatric consultations
Randomization 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 Randomization will be carried out with a block design 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
Population and sample Pediatric nurses and pediatricians PNP involved in the administration of systematic childhood vaccines and working in primary care centers in Barcelona city N 41 centers N 342 pediatric care providers and Central Catalonia N38 centers N 108 pediatric care providers For the recruitment the research team will contact the Head of Pediatrics in each of the regions where the training is planned to be implemented Study participation will be offered after agreement of the primary care centers An information session will be held to ensure participants understand the studys purposes procedures and timeline as well as to address questions or potential concerns Based on previous research conducted with PNP in Barcelona the investigators estimate a baseline self-efficacy related to vaccination promotion and vaccine-hesitant management of 71 The investigators assume this percentage to be similar for PNP in Central Catalonia Accepting an alpha risk of 005 and a beta risk of 02 in a bilateral contrast 82 subjects in each group will be able to detect a statistically significant difference of 18 with an estimated loss of follow-up rate of 10 Since randomization will be done by clusters a cluster effect of 165 will be applied to the sample size resulting in an overall sample of 270 participants 135 per group Therefore the study will be powered enough to detect at least a difference of 18 in PNPs self-efficacy
Recruitment PNP will enlist in the study by completing a brief online form available via Microsoft Forms This form will be accessible through the studys information brochure and shared in the online information session Upon receiving the applications the research team will grant participants access to the online learning platform Moodle To complete the enrollment all participants will have to read the participant information sheet and provide signed informed consent
Data collection PNP will be asked to complete a baseline and post-intervention questionnaire available on the online learning platform after enrollment and intervention periods The questionnaire has been built based on previously validated scales from existing literature and has been pre-tested and piloted As the questionnaires will be self-administered the research team will perform daily checks to ensure data quality and completeness The questionnaires will collect PNPs knowledge on vaccine safety and effectiveness key childhood immunization beliefs self-efficacy in managing vaccine-hesitant situations frequency of vaccine promotion behaviors during pediatric consultations practice immunization organization culture as well as standard demographic information age sex professional role years of practice offspring and region PNPs psychosocial determinants and vaccination promotion behaviors will be measured using five-point Likert scales Data will be securely handled and stored to maintain confidentiality with access restricted to the research team members only
Statistical analysis plan Analyses will be performed by intention to treat including all subjects in the randomized pediatric teams and per protocol Differences between pre-post measures within intervention and control groups will be assessed with multivariate logistic regression models Models will be adjusted by baseline values age sex having offspring profession and years of professional practice Statistical significance will be set at α005 Analysis will be performed using R software version 430
Qualitative study
Study design Descriptive qualitative study with a phenomenological design approach
Population and sample PNP in public primary care centers in Barcelona city Catalonia Spain and Central Catalonia Catalonia Spain Sampling units will be chosen based on theoretically predefined profiles In this study the professional role in pediatric care medicine or nursing may influence experiences and discourse regarding intervention satisfaction and outcomes To prevent professional hierarchy from interfering the groups will be segmented by type of professional nurses and pediatricians The investigators will use criterion sampling to select PNP who have successfully completed the training program Participants will be selected considering discursive heterogeneity based on criteria including gender years of professional experience rurality offspring socioeconomic status of the basic health area number of attempts to pass the programs exam and overall degree of satisfaction with the training program To achieve data saturation the investigators plan to conduct four discussion groups two with pediatric nursing staff and two with pediatric medical staff The sampling will be cumulative and sequential and the final sample size will be determined by the saturation of the information Recruitment will continue until information sufficiency is reached meaning no new themes or insights emerge from the discussions
Recruitment PNP who have completed the training program will be organized into the four discussion groups based on pre-established sampling criteria Selected individuals will receive an email invitation to participate along with study information Discussion groups will be scheduled to maximize participants availability In cases where a group does not meet the minimum required number of participants 6-8 participants per group the research team will contact other individuals with similar profiles who meet the sampling criteria To encourage participation PNP will receive a 50 euros gift card
Data collection and management PNP perceptions opinions and experiences regarding the intervention will be explored through focus groups carried out at least three months after the conclusion of the training program Focus groups will be held online via video calls using the Teams platform allowing the participation of professionals from both study regions Barcelona and Central Catalonia Each group will be facilitated by a moderator and assisted by an observer A semi-structured guide will ensure comprehensive exploration of all relevant topics The topic guide will cover questions related to 1 intervention implementation most and least valued aspects barriers facilitators satisfaction perceived quality and suggestions and 2 intervention outcomes perceived changes on communication skills knowledge attitudes towards vaccination self-efficacy in consultations with vaccine-hesitant patients and social norms Sessions are expected to last approximately 15 to 2 hours and will be recorded in audio and video formats with prior verbal consent from all participants Recordings will be securely stored transcribed and analyzed anonymously Access to recordings and transcripts will be restricted to the research team
Method of analysis Focus groups sessions will be transcribed using the Turboscribe tool One member of the research team will revise and verify the transcription outputs and incorporate relevant observations made by the observer into the final transcripts The investigators will perform thematic analysis supported by ATLASti software version 241 Analysis plan a identify the basic units of meaning b generate mixed categories based on the predefined topic guide and the emerging data c text coding d analyze content between and within categories e create subcategories f triangulate results All stages of the coding and categorization processes will be discussed and agreed by all research team members to ensure methodological consistency and data quality
How pediatric nurses and pediatricians PNP handle vaccination conversations can significantly influence vaccination decisions PNP who are at the frontline of administering childhood vaccinations may not be well-equipped to address vaccination doubts or concerns of parents or legal guardians A study conducted among PNP in primary care centers in Barcelona revealed that only 71 of professionals felt they had sufficient training information and resources to adequately respond to questions from vaccine-hesitant families This lack of preparedness was reported by 40 of nurses and 17 of pediatricians Additionally PNP also expressed a need for more information about vaccines in online 523 or through in-person training sessions 502
Intervention mapping IM is a theory- and evidenced-based iterative tool useful in the planning of health promotion interventions Using the IM framework the investigators developed a 12-hour training program to increase PNPs knowledge self-efficacy communication skills and organizational culture for 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 include short video lectures video case studies and readings In-person activities involve role-playings and group discussions The program was accredited by the Catalan Council for Continuing Education of Health Professions CCFCPS To incentivize participation providers completing all program activities including a multiple-choice final test will receive 25 accredited continuing medical education credits
Mixed-methods evaluations provide a more comprehensive and profound understanding of intervention effects and help identify areas for improvement This study aims to evaluate the effectiveness of an intervention on PNP psychosocial determinants knowledge beliefs attitudes and self-efficacy and behaviors in promoting vaccination and addressing vaccine hesitancy during pediatric consultations using quantitative and qualitative methods Specifically the investigators will assess PNPs satisfaction with the 12-hour training program and changes in their psychosocial determinants and vaccination behaviors
Methods
The investigators will employ a mixed-method approach for the evaluation of the intervention Quantitative and qualitative data will be integrated through triangulation principles Quantitative analysis will involve the design of a two-arm cluster randomized control trial For the qualitative evaluation the investigators plan to carry out a descriptive qualitative study with a phenomenological approach
Cluster Randomized Control Trial
Study design Two-arm parallel cluster randomized controlled trial during 5 months with pediatric care providers in public primary care centers in Barcelona city Catalonia Spain and Central Catalonia Catalonia Spain Intervention group will receive a 12-hour online and in-person training program for improving vaccination promotion and vaccine hesitancy management during pediatric consultations
Randomization 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 Randomization will be carried out with a block design 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
Population and sample Pediatric nurses and pediatricians PNP involved in the administration of systematic childhood vaccines and working in primary care centers in Barcelona city N 41 centers N 342 pediatric care providers and Central Catalonia N38 centers N 108 pediatric care providers For the recruitment the research team will contact the Head of Pediatrics in each of the regions where the training is planned to be implemented Study participation will be offered after agreement of the primary care centers An information session will be held to ensure participants understand the studys purposes procedures and timeline as well as to address questions or potential concerns Based on previous research conducted with PNP in Barcelona the investigators estimate a baseline self-efficacy related to vaccination promotion and vaccine-hesitant management of 71 The investigators assume this percentage to be similar for PNP in Central Catalonia Accepting an alpha risk of 005 and a beta risk of 02 in a bilateral contrast 82 subjects in each group will be able to detect a statistically significant difference of 18 with an estimated loss of follow-up rate of 10 Since randomization will be done by clusters a cluster effect of 165 will be applied to the sample size resulting in an overall sample of 270 participants 135 per group Therefore the study will be powered enough to detect at least a difference of 18 in PNPs self-efficacy
Recruitment PNP will enlist in the study by completing a brief online form available via Microsoft Forms This form will be accessible through the studys information brochure and shared in the online information session Upon receiving the applications the research team will grant participants access to the online learning platform Moodle To complete the enrollment all participants will have to read the participant information sheet and provide signed informed consent
Data collection PNP will be asked to complete a baseline and post-intervention questionnaire available on the online learning platform after enrollment and intervention periods The questionnaire has been built based on previously validated scales from existing literature and has been pre-tested and piloted As the questionnaires will be self-administered the research team will perform daily checks to ensure data quality and completeness The questionnaires will collect PNPs knowledge on vaccine safety and effectiveness key childhood immunization beliefs self-efficacy in managing vaccine-hesitant situations frequency of vaccine promotion behaviors during pediatric consultations practice immunization organization culture as well as standard demographic information age sex professional role years of practice offspring and region PNPs psychosocial determinants and vaccination promotion behaviors will be measured using five-point Likert scales Data will be securely handled and stored to maintain confidentiality with access restricted to the research team members only
Statistical analysis plan Analyses will be performed by intention to treat including all subjects in the randomized pediatric teams and per protocol Differences between pre-post measures within intervention and control groups will be assessed with multivariate logistic regression models Models will be adjusted by baseline values age sex having offspring profession and years of professional practice Statistical significance will be set at α005 Analysis will be performed using R software version 430
Qualitative study
Study design Descriptive qualitative study with a phenomenological design approach
Population and sample PNP in public primary care centers in Barcelona city Catalonia Spain and Central Catalonia Catalonia Spain Sampling units will be chosen based on theoretically predefined profiles In this study the professional role in pediatric care medicine or nursing may influence experiences and discourse regarding intervention satisfaction and outcomes To prevent professional hierarchy from interfering the groups will be segmented by type of professional nurses and pediatricians The investigators will use criterion sampling to select PNP who have successfully completed the training program Participants will be selected considering discursive heterogeneity based on criteria including gender years of professional experience rurality offspring socioeconomic status of the basic health area number of attempts to pass the programs exam and overall degree of satisfaction with the training program To achieve data saturation the investigators plan to conduct four discussion groups two with pediatric nursing staff and two with pediatric medical staff The sampling will be cumulative and sequential and the final sample size will be determined by the saturation of the information Recruitment will continue until information sufficiency is reached meaning no new themes or insights emerge from the discussions
Recruitment PNP who have completed the training program will be organized into the four discussion groups based on pre-established sampling criteria Selected individuals will receive an email invitation to participate along with study information Discussion groups will be scheduled to maximize participants availability In cases where a group does not meet the minimum required number of participants 6-8 participants per group the research team will contact other individuals with similar profiles who meet the sampling criteria To encourage participation PNP will receive a 50 euros gift card
Data collection and management PNP perceptions opinions and experiences regarding the intervention will be explored through focus groups carried out at least three months after the conclusion of the training program Focus groups will be held online via video calls using the Teams platform allowing the participation of professionals from both study regions Barcelona and Central Catalonia Each group will be facilitated by a moderator and assisted by an observer A semi-structured guide will ensure comprehensive exploration of all relevant topics The topic guide will cover questions related to 1 intervention implementation most and least valued aspects barriers facilitators satisfaction perceived quality and suggestions and 2 intervention outcomes perceived changes on communication skills knowledge attitudes towards vaccination self-efficacy in consultations with vaccine-hesitant patients and social norms Sessions are expected to last approximately 15 to 2 hours and will be recorded in audio and video formats with prior verbal consent from all participants Recordings will be securely stored transcribed and analyzed anonymously Access to recordings and transcripts will be restricted to the research team
Method of analysis Focus groups sessions will be transcribed using the Turboscribe tool One member of the research team will revise and verify the transcription outputs and incorporate relevant observations made by the observer into the final transcripts The investigators will perform thematic analysis supported by ATLASti software version 241 Analysis plan a identify the basic units of meaning b generate mixed categories based on the predefined topic guide and the emerging data c text coding d analyze content between and within categories e create subcategories f triangulate results All stages of the coding and categorization processes will be discussed and agreed by all research team members to ensure methodological consistency and data quality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None