Vaccine RefusalNCT06074237
Improving Vaccine Counseling Skills Among Residents Using Educational Modules and Standardized Patient Encounters
A study testing Immersive resident education and Standardized patient (SP) encounter in people with Vaccine Refusal and Vaccine-Preventable Diseases, run by Corewell Health East at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Refusal, Vaccine-Preventable Diseases, Physician-Patient Relations
- What is being tested?
- Immersive resident education and Standardized patient (SP) encounter
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pediatric, medicine/pediatric, and family medicine residents of all training levels
- Employed by Beaumont Hospitals - Royal Oak, Troy, Wayne, or Grosse Pointe.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Vaccine Counseling Skills Among Pediatric, Medicine/Pediatric and Family Medicine Residents Pilot Study: Evaluation, Education, and Promotion of Vaccine Confidence Using Educational Modules and Standardized Patient Encounters
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.
Read the detailed description
The World Health Organization (WHO) defines vaccine hesitancy (VH) as "the reluctance or refusal to vaccinate despite the availability of vaccines" and included it in the list of top ten threats to global health [WHO]. The coverage levels for most childhood vaccines remain high in the United States where data shows vaccination rate of >90% in 24-months-old children for Polio, MMR, Hepatitis B, and Varicella; >80% for Diphtheria, Tetanus, Pertussis, and 79.6% for Haemophilus Influenza type B (Hib) in 2019. However, studies demonstrated an uptrend in vaccine hesitancy. One national survey performed in 2009 involving randomly selected participants revealed 54% parents expressed concern regarding vaccine safety and 11.5% refused recommended vaccines, despite 90% respondents agreed vaccines are a good way to prevent diseases. A survey of pediatricians in Connecticut reported increased parental vaccination concerns and refusals compared with 10 years ago, and more remarkably in the last five years. Although not always resulting in refusal, vaccine hesitancy also appears to contribute to delayed immunization or usage of alternative schedules.
Numerous reasons contribute to this phenomenon, including coincidental temporal association between adverse outcomes and vaccine administration, presence of vaccine mandates, poor knowledge of vaccine preventable diseases and lack of trust in public health agencies. Controversies and myths on vaccination safety are spread easily in social media and through disinformation campaigns. Ironically, the success of vaccines also contributes to VH in which effective immunization programs lead to limited exposure and knowledge of vaccine-preventable diseases, thus many parents ended up questioning their necessity. Other contributing factors include concern for safety, perceived lack of involvement in the decision-making process, lack of adequate time and resources, and religious or philosophical objections.
Research has shown that patients who receive a strong recommendation from a healthcare provider are 4-5 times more likely to be vaccinated. A study involving 20 pediatric primary care practices found that one of the most common recommended potential practice-level strategies to tackle VH is to provide training to improve vaccine counseling effectiveness and efficiency. Strikingly, all respondents of the study admitted to never having received any formal training in vaccine counseling. The study stressed the importance of training future primary care providers on how to communicate with vaccine-hesitant parents, including to residents and medical students. Pediatric residents need to be well prepared to address these issues, and have the knowledge, confidence, and competency to encourage VH parents to vaccinate their children.
The primary goal of this project is to develop and evaluate an interactive educational program, which will include online training modules and standardized patient encounters, for the pediatric, family medicine and medicine/pediatric residents that provides evidence-based information and skill-building strategies that will teach and refine vaccine counseling skills to promote vaccine uptake among vaccination-hesitant patient and/or families. Based upon the Announce-Inquire-Mirror-Secure (AIMS) framework, the program will deliver this information for vaccine counseling in general and within the context of the HPV, Influenza, MMR, and COVID-19 vaccines, which are the most commonly associated with myths and controversies. The impact of the interactive vaccine education program on vaccine uptake will be evaluated through comparison of pre- and post-intervention vaccination rates in the Beaumont residency clinics where residents provide patient care, residents' vaccine safety and vaccine hesitancy knowledge and provider behavior and communication skills on this topic during standardized patient encounters.
- Being tested
- Immersive resident education, Standardized patient (SP) encounter
- Keywords
- Resident communication skills, Vaccine counselling, Resident education, Standardized patient encounter, Vaccine Hesitancy
- Medical subject headings
- Vaccination Refusal, Vaccine-Preventable Diseases, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive resident educationOther
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.
Standardized patient (SP) encounterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Immersive resident education; Other: Standardized patient (SP) encounter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Difference between pre-intervention and post-intervention rates of MMR vaccination in the pediatric resident clinic
Measured: baseline to 18 months
Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in medicine/pediatric resident clinic
Difference between pre-intervention and post-intervention rates of MMR vaccination in the medicine/pediatric resident clinic
Measured: baseline to 18 months
Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in family medicine resident clinic
Difference between pre-intervention and post-intervention rates of MMR vaccination in the family medicine resident clinic
Measured: baseline to 18 months
Change in Human Papilloma Virus (HPV) vaccine rate with provider education in pediatrics resident clinic
Difference between pre-intervention and post-intervention rates of HPV vaccination in the pediatrics resident clinic
Measured: baseline to 18 months
Change in Human Papilloma Virus (HPV) vaccine rate with provider education in medicine/pediatric resident clinic
Difference between pre-intervention and post-intervention rates of HPV vaccination in the medicine/pediatric resident clinic
Measured: baseline to 18 months
Change in Human Papilloma Virus (HPV) vaccine rate with provider education in family medicine resident clinic
Difference between pre-intervention and post-intervention rates of HPV vaccination in the family medicine resident clinic
Measured: baseline to 18 months
Change in Coronavirus-19 (COVID) vaccine rate with provider education in pediatric resident clinic
Difference between pre-intervention and post-intervention rates of COVID vaccination in the pediatric resident clinic
Measured: baseline to 18 months
Change in Coronavirus-19 (COVID) vaccine rate with provider education in medicine/pediatric resident clinic
Difference between pre-intervention and post-intervention rates of COVID vaccination in the medicine/pediatric resident clinic
Measured: baseline to 18 months
Change in Coronavirus-19 (COVID) vaccine rate with provider education in family medicine resident clinic
Difference between pre-intervention and post-intervention rates of COVID vaccination in the family medicine resident clinic
Measured: baseline to 18 months
Change in Influenza vaccine rate with provider education in pediatric resident clinic
Difference between pre-intervention and post-intervention rates of Influenza vaccination in the pediatric resident clinic
Measured: baseline to 18 months
Change in Influenza vaccine rate with provider education in medicine/pediatric resident clinic
Difference between pre-intervention and post-intervention rates of Influenza vaccination in the medicine/pediatric resident clinic
Measured: baseline to 18 months
Change in Influenza vaccine rate with provider education in family medicine resident clinic
Difference between pre-intervention and post-intervention rates of Influenza vaccination in the family medicine resident clinic
Measured: baseline to 18 months
Change in total vaccine rate with provider education
Difference between total pre-intervention and total post-intervention vaccination rates following provider education
Measured: baseline to 18 months
Change in total vaccine rate with provider education in pediatric clinic
Difference between total pre-intervention and total post-intervention vaccination rates following provider education in the pediatric clinic
Measured: baseline to 18 months
Change in total vaccine rate with provider education in medicine/pediatric resident clinic
Difference between total pre-intervention and total post-intervention vaccination rates following provider education in the medicine/pediatric resident clinic
Measured: baseline to 18 months
Change in total vaccine rate with provider education in family medicine resident clinic
Difference between total pre-intervention and total post-intervention vaccination rates following provider education in the family medicine resident clinic
Measured: baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Apr 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vaccine RefusalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-blinded, single group educational intervention
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Andrea Hernandez-Troya, Corewell Health East
- Investigators
- Andrea C Hernandez Troya, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074237
- Sponsor's protocol ID
- 2023-160
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data shared.
Publications
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.
PubMed 20194286Leib 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.
PubMed 21812165Salmon 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.
PubMed 26337116Wilson 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.
PubMed 33097547Barrows 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.
PubMed 26096835Mohanty 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.
PubMed 29947574Williams 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.
PubMed 24731808Real 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.
PubMed 28126612Pahud 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.
PubMed 32988690
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vaccine Counseling Skills Among Pediatric, Medicine/Pediatric and Family Medicine Residents Pilot Study: Evaluation, Education, and Promotion of Vaccine Confidence Using Educational Modules and Standardized Patient Encounters
- ClinicalTrials.gov ID
- NCT06074237
- Acronym / sponsor ID
- 2023-160
- Keywords
- Resident communication skills, Vaccine counselling, Resident education, Standardized patient encounter, Vaccine Hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The World Health Organization (WHO) defines vaccine hesitancy (VH) as "the reluctance or refusal to vaccinate despite the availability of vaccines" and included it in the list of top ten threats to global health [WHO]. The coverage levels for most childhood vaccines remain high in the United States where data shows vaccination rate of >90% in 24-months-old children for Polio, MMR, Hepatitis B, and Varicella; >80% for Diphtheria, Tetanus, Pertussis, and 79.6% for Haemophilus Influenza type B (Hib) in 2019. However, studies demonstrated an uptrend in vaccine hesitancy. One national survey performed in 2009 involving randomly selected participants revealed 54% parents expressed concern regarding vaccine safety and 11.5% refused recommended vaccines, despite 90% respondents agreed vaccines are a good way to prevent diseases. A survey of pediatricians in Connecticut reported increased parental vaccination concerns and refusals compared with 10 years ago, and more remarkably in the last five years. Although not always resulting in refusal, vaccine hesitancy also appears to contribute to delayed immunization or usage of alternative schedules.
Numerous reasons contribute to this phenomenon, including coincidental temporal association between adverse outcomes and vaccine administration, presence of vaccine mandates, poor knowledge of vaccine preventable diseases and lack of trust in public health agencies. Controversies and myths on vaccination safety are spread easily in social media and through disinformation campaigns. Ironically, the success of vaccines also contributes to VH in which effective immunization programs lead to limited exposure and knowledge of vaccine-preventable diseases, thus many parents ended up questioning their necessity. Other contributing factors include concern for safety, perceived lack of involvement in the decision-making process, lack of adequate time and resources, and religious or philosophical objections.
Research has shown that patients who receive a strong recommendation from a healthcare provider are 4-5 times more likely to be vaccinated. A study involving 20 pediatric primary care practices found that one of the most common recommended potential practice-level strategies to tackle VH is to provide training to improve vaccine counseling effectiveness and efficiency. Strikingly, all respondents of the study admitted to never having received any formal training in vaccine counseling. The study stressed the importance of training future primary care providers on how to communicate with vaccine-hesitant parents, including to residents and medical students. Pediatric residents need to be well prepared to address these issues, and have the knowledge, confidence, and competency to encourage VH parents to vaccinate their children.
The primary goal of this project is to develop and evaluate an interactive educational program, which will include online training modules and standardized patient encounters, for the pediatric, family medicine and medicine/pediatric residents that provides evidence-based information and skill-building strategies that will teach and refine vaccine counseling skills to promote vaccine uptake among vaccination-hesitant patient and/or families. Based upon the Announce-Inquire-Mirror-Secure (AIMS) framework, the program will deliver this information for vaccine counseling in general and within the context of the HPV, Influenza, MMR, and COVID-19 vaccines, which are the most commonly associated with myths and controversies. The impact of the interactive vaccine education program on vaccine uptake will be evaluated through comparison of pre- and post-intervention vaccination rates in the Beaumont residency clinics where residents provide patient care, residents' vaccine safety and vaccine hesitancy knowledge and provider behavior and communication skills on this topic during standardized patient encounters.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-blinded, single group educational intervention
| Arm | Type | Receives |
|---|---|---|
| Interactive Vaccine Education Program for resident providers | Experimental | Other: Immersive resident education, Other: Standardized patient (SP) encounterResident 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pediatric, medicine/pediatric, and family medicine residents of all training levels
- Employed by Beaumont Hospitals - Royal Oak, Troy, Wayne, or Grosse Pointe.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive resident educationUsing 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. | Other | Interactive Vaccine Education Program for resident providers |
| Standardized patient (SP) encounterAfter 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. | Other | Interactive Vaccine Education Program for resident providers |
Primary outcome
Changes in provider confidence following education
Time frame: baseline and up to 4 months after 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.
Change in provider attitudes following education
Time frame: baseline and up to 4 months after 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.
Change in provider knowledge regarding vaccination
Time frame: baseline and up to 4 months after education
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.
Score on standardized patient checklist
Time frame: after standardized patient encounter, an average of 3 to 4 months after enrollment
Total score on evaluation checklist for standardized patient encounter following education. Maximum score is 16 points, minimum score is 0.
16 secondary outcomes
Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in pediatric resident clinic
Time frame: baseline to 18 months
Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in medicine/pediatric resident clinic
Time frame: baseline to 18 months
Change in Measles/Mumps/Rubella (MMR) vaccine rate with provider education in family medicine resident clinic
Time frame: baseline to 18 months
Change in Human Papilloma Virus (HPV) vaccine rate with provider education in pediatrics resident clinic
Time frame: baseline to 18 months
Change in Human Papilloma Virus (HPV) vaccine rate with provider education in medicine/pediatric resident clinic
Time frame: baseline to 18 months
Change in Human Papilloma Virus (HPV) vaccine rate with provider education in family medicine resident clinic
Time frame: baseline to 18 months
Change in Coronavirus-19 (COVID) vaccine rate with provider education in pediatric resident clinic
Time frame: baseline to 18 months
Change in Coronavirus-19 (COVID) vaccine rate with provider education in medicine/pediatric resident clinic
Time frame: baseline to 18 months
Change in Coronavirus-19 (COVID) vaccine rate with provider education in family medicine resident clinic
Time frame: baseline to 18 months
Change in Influenza vaccine rate with provider education in pediatric resident clinic
Time frame: baseline to 18 months
Change in Influenza vaccine rate with provider education in medicine/pediatric resident clinic
Time frame: baseline to 18 months
Change in Influenza vaccine rate with provider education in family medicine resident clinic
Time frame: baseline to 18 months
Change in total vaccine rate with provider education
Time frame: baseline to 18 months
Change in total vaccine rate with provider education in pediatric clinic
Time frame: baseline to 18 months
Change in total vaccine rate with provider education in medicine/pediatric resident clinic
Time frame: baseline to 18 months
Change in total vaccine rate with provider education in family medicine resident clinic
Time frame: baseline to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 20194286Freed 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.
- Background: PubMed 21812165Leib 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.
- Background: PubMed 26337116Salmon 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.
- Background: PubMed 33097547Wilson 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.
- Background: PubMed 26096835Barrows 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.
- Background: PubMed 29947574Mohanty 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.
- Background: PubMed 24731808Williams 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.
- Background: PubMed 28126612Real 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.
- Background: PubMed 32988690Pahud 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.
- WHO, "Ten threats to global health in 2019Link provided by the sponsor.
- Individual participant dataSharing planned: No. No individual patient data shared.
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Vaccine Hesitancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea C Hernandez Troya, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive resident education and Standardized patient (SP) encounter in people with Vaccine Refusal and Vaccine-Preventable Diseases, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in provider confidence following education (time frame: baseline and up to 4 months after education). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074237, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.