NCT06074237

Brief Summary

Unfortunately, only 40% of US pediatric residency programs reported in a survey that vaccine safety and counseling training is provided to residents. The success of a residency curriculum focused on communication strategies with patients hesitant to receive the influenza vaccine has been demonstrated, finding a decreased rate of vaccination refusal in the post curricular period. In a recent 2020 study, it demonstrated the positive impact of an online vaccine curriculum on resident vaccine knowledge and self-reported confidence in counseling vaccine hesitant patients. Providers have the potential to impact a substantial pediatric patient population. The outpatient clinics where the residents included in this study care for patients had 9942 pediatric visits in 2021. Each visit is an opportunity to talk with families about vaccines, address concerns and to administer vaccines when needed. The hypothesize is that interactive educational interventions using the online training modules combined with the standardized patient encounters will increase resident vaccine knowledge and confidence, and enhance communication and counseling skills, thereby improving vaccination rates of Human Papilloma Virus (HPV), Influenza, Measles/Mumps/Rubella (MMR) and Coronavirus (COVID-19) in the Beaumont residency clinics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

April 25, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

September 20, 2023

Last Update Submit

January 20, 2026

Conditions

Keywords

Resident communication skillsVaccine counsellingResident educationStandardized patient encounterVaccine Hesitancy

Outcome Measures

Primary Outcomes (4)

  • Changes in provider confidence following education

    Difference in total score between pre-education and post-education survey of resident confidence in patient vaccine counselling, as measured by a summation score of 8 questions answered on a 5-point Likert scale, where 1=strongly disagree and 5 = strongly agree; a higher score indicates more confidence (maximum 40 points). A positive difference indicates an increase in confidence after education, and a negative number indicates a decrease in confidence after education.

    baseline and up to 4 months after education

  • Change in provider attitudes following education

    Difference in total score between pre-education and post-education survey of resident attitudes towards vaccination hesitancy, as measured by a summation score of 8 questions answered on a 5-point Likert scale, where 1=strongly disagree and 5 = strongly agree; a higher score indicates a positive attitude toward vaccines and a lower score indicates a negative attitude toward vaccination (maximum of 40 points). A positive difference indicates a more positive attitude after education, and a negative number indicates a more negative attitude after education.

    baseline and up to 4 months after education

  • Change in provider knowledge regarding vaccination

    Difference in scores between pre-education and post-education on a 15-question, multiple choice evaluation of provider knowledge about vaccine safety and efficacy. A higher score indicates more provider knowledge. A positive difference indicates an increase in knowledge after education, and a negative number indicates a decrease in knowledge after education.

    baseline and up to 4 months after education

  • Score on standardized patient checklist

    Total score on evaluation checklist for standardized patient encounter following education. Maximum score is 16 points, minimum score is 0.

    after standardized patient encounter, an average of 3 to 4 months after enrollment

Secondary Outcomes (16)

  • Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in pediatric resident clinic

    baseline to 18 months

  • Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in medicine/pediatric resident clinic

    baseline to 18 months

  • Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in family medicine resident clinic

    baseline to 18 months

  • Change in Human Papilloma Virus (HPV) vaccine rate with provider education in pediatrics resident clinic

    baseline to 18 months

  • Change in Human Papilloma Virus (HPV) vaccine rate with provider education in medicine/pediatric resident clinic

    baseline to 18 months

  • +11 more secondary outcomes

Study Arms (1)

Interactive Vaccine Education Program for resident providers

EXPERIMENTAL

Resident providers in pediatric, pediatric/medicine and family medicine clinics will be given interactive educational interventions using online training modules combined with standardized patient encounters to teach and refine vaccine counseling skills

Other: Immersive resident educationOther: Standardized patient (SP) encounter

Interventions

After completion of the Immersive Resident Education modules, residents will participate in a telemedicine standardized patient encounter. They will interview a vaccine-hesitant "patient" and this encounter will be video recorded. At the end of the encounter, the SP will provide the resident with patient-centered feedback on their communication skills. The SP will also complete a communication checklist regarding each resident encounter and the research team will review the recorded encounters for accuracy of medical content conveyed during each encounter.

Interactive Vaccine Education Program for resident providers

Using the AIMS framework (Announce, Inquire, Mirror, Secure), residents will complete online modules designed to improve vaccine education, promote vaccine confidence and improve vaccine counseling in general. There will also be modules dispelling myths and controversies specific to HPV, MMR, Covid and influenza vaccines that often limit or prevent vaccination uptake.

Interactive Vaccine Education Program for resident providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatric, medicine/pediatric, and family medicine residents of all training levels
  • Employed by Beaumont Hospitals - Royal Oak, Troy, Wayne, or Grosse Pointe.

You may not qualify if:

  • Residents not enrolled in pediatric, medicine/pediatric, or family medicine programs
  • Residents receiving training at hospitals other than Beaumont Hospital - Royal Oak, Troy, Wayne, or Grosse Pointe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

Related Publications (9)

  • Freed GL, Clark SJ, Butchart AT, Singer DC, Davis MM. Parental vaccine safety concerns in 2009. Pediatrics. 2010 Apr;125(4):654-9. doi: 10.1542/peds.2009-1962. Epub 2010 Mar 1.

    PMID: 20194286BACKGROUND
  • Leib S, Liberatos P, Edwards K. Pediatricians' experience with and response to parental vaccine safety concerns and vaccine refusals: a survey of Connecticut pediatricians. Public Health Rep. 2011 Jul-Aug;126 Suppl 2(Suppl 2):13-23. doi: 10.1177/00333549111260S203.

    PMID: 21812165BACKGROUND
  • Salmon DA, Dudley MZ, Glanz JM, Omer SB. Vaccine Hesitancy: Causes, Consequences, and a Call to Action. Am J Prev Med. 2015 Dec;49(6 Suppl 4):S391-8. doi: 10.1016/j.amepre.2015.06.009. Epub 2015 Aug 31.

    PMID: 26337116BACKGROUND
  • Wilson SL, Wiysonge C. Social media and vaccine hesitancy. BMJ Glob Health. 2020 Oct;5(10):e004206. doi: 10.1136/bmjgh-2020-004206. Epub 2020 Oct 23.

    PMID: 33097547BACKGROUND
  • Barrows MA, Coddington JA, Richards EA, Aaltonen PM. Parental Vaccine Hesitancy: Clinical Implications for Pediatric Providers. J Pediatr Health Care. 2015 Jul-Aug;29(4):385-94. doi: 10.1016/j.pedhc.2015.04.019.

    PMID: 26096835BACKGROUND
  • Mohanty S, Carroll-Scott A, Wheeler M, Davis-Hayes C, Turchi R, Feemster K, Yudell M, Buttenheim AM. Vaccine Hesitancy in Pediatric Primary Care Practices. Qual Health Res. 2018 Nov;28(13):2071-2080. doi: 10.1177/1049732318782164. Epub 2018 Jun 27.

    PMID: 29947574BACKGROUND
  • Williams SE, Swan R. Formal training in vaccine safety to address parental concerns not routinely conducted in U.S. pediatric residency programs. Vaccine. 2014 May 30;32(26):3175-8. doi: 10.1016/j.vaccine.2014.04.001. Epub 2014 Apr 13.

    PMID: 24731808BACKGROUND
  • Real FJ, DeBlasio D, Beck AF, Ollberding NJ, Davis D, Cruse B, Samaan Z, McLinden D, Klein MD. A Virtual Reality Curriculum for Pediatric Residents Decreases Rates of Influenza Vaccine Refusal. Acad Pediatr. 2017 May-Jun;17(4):431-435. doi: 10.1016/j.acap.2017.01.010. Epub 2017 Jan 23.

    PMID: 28126612BACKGROUND
  • Pahud B, Elizabeth Williams S, Lee BR, Lewis KO, Middleton DB, Clark S, Humiston SG. A randomized controlled trial of an online immunization curriculum. Vaccine. 2020 Oct 27;38(46):7299-7307. doi: 10.1016/j.vaccine.2020.09.043. Epub 2020 Sep 26.

    PMID: 32988690BACKGROUND

Related Links

MeSH Terms

Conditions

Vaccination RefusalVaccine-Preventable DiseasesVaccination Hesitancy

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehaviorInfections

Study Officials

  • Andrea C Hernandez Troya, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Non-blinded, single group educational intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Clinical Simulation Director

Study Record Dates

First Submitted

September 20, 2023

First Posted

October 10, 2023

Study Start

April 25, 2024

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

No individual patient data shared.

Locations