NCT04368455

Brief Summary

Our approach will be to implement Virtual Immersive Communication Training on Recommending Immunizations (VICTORI), an intervention that includes a self-directed app based curriculum and VR simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians. A single-site intervention assessing the efficacy of VICTORI in increasing HPV vaccine rates will be conducted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

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

April 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

April 27, 2020

Results QC Date

September 27, 2022

Last Update Submit

March 18, 2023

Conditions

Human Papilloma Virus

Keywords

Human Papilloma VirusHuman Papilloma Virus VaccineVirtual realitySimulation-based medical education

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation

    The primary outcome was the percent change from pre versus post VICTORI in rates of HPV vaccine initiation among eligible patients presenting to clinic.

    6 months

Secondary Outcomes (5)

  • Physicians Perceived Barriers

    3 months

  • Physicians Perceived Risk

    3 months

  • Physicians Attitudes Toward the HPV Vaccine

    3 months

  • Physicians Strength of Recommendation of the HPV Vaccine

    3 months

  • Physicians Self-efficacy

    3 months

Study Arms (2)

Primary Care Clinic

EXPERIMENTAL

Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the VR simulations independently.Next, we will implement VICTORI with staff including nurses and medical assistants in groups of up to 15-20 participants (phase II; secondary outcome). Staff will watch a 5-minute video on evidence-based practices in recommending the HPV vaccine and observe a facilitator and clinician participating in the VICTORI VR simulations, and then engage in a 5-minute debriefing.

Behavioral: Virtual Immersive Communication Training on Recommending Immunizations (VICTORI)

Control Primary Care Clinic

ACTIVE COMPARATOR

Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.

Behavioral: HPV Same Way Same Day App

Interventions

Virtual Immersive Communication Training on Recommending Immunizations (VICTORI)BEHAVIORAL

An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.

Primary Care Clinic
HPV Same Way Same Day AppBEHAVIORAL

An intervention that includes a self-directed app based curriculum

Control Primary Care Clinic

Eligibility Criteria

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

You may qualify if:

  • Physician (Attending or Resident) at control or intervention clinic
  • Staff Member (Medical Assistant or Nurse) at intervention clinic

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (8)

  • Rosen BL, Bishop JM, Anderson R, Real FJ, Klein MD, Kreps GL. A content analysis of HPV vaccine online continuing medical education purpose statements and learning objectives. Hum Vaccin Immunother. 2019;15(7-8):1508-1518. doi: 10.1080/21645515.2019.1587273. Epub 2019 Apr 22.

    PMID: 30932718BACKGROUND

  • Rosen BL, Bishop JM, McDonald SL, Kahn JA, Kreps GL. Quality of Web-Based Educational Interventions for Clinicians on Human Papillomavirus Vaccine: Content and Usability Assessment. JMIR Cancer. 2018 Feb 16;4(1):e3. doi: 10.2196/cancer.9114.

    PMID: 29453187BACKGROUND

  • Rosen BL, Shepard A, Kahn JA. US Health Care Clinicians' Knowledge, Attitudes, and Practices Regarding Human Papillomavirus Vaccination: A Qualitative Systematic Review. Acad Pediatr. 2018 Mar;18(2S):S53-S65. doi: 10.1016/j.acap.2017.10.007.

    PMID: 29502639BACKGROUND

  • Rosen BL, Shew ML, Zimet GD, Ding L, Mullins TLK, Kahn JA. Human Papillomavirus Vaccine Sources of Information and Adolescents' Knowledge and Perceptions. Glob Pediatr Health. 2017 Nov 24;4:2333794X17743405. doi: 10.1177/2333794X17743405. eCollection 2017.

    PMID: 29204462BACKGROUND

  • Real FJ, DeBlasio D, Ollberding NJ, Davis D, Cruse B, Mclinden D, Klein MD. Resident perspectives on communication training that utilizes immersive virtual reality. Educ Health (Abingdon). 2017 Sep-Dec;30(3):228-231. doi: 10.4103/efh.EfH_9_17.

    PMID: 29786025BACKGROUND

  • 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

  • Real FJ, Meisman A, Rosen BL. Usability matters for virtual reality simulations teaching communication. Med Educ. 2020 Nov;54(11):1067-1068. doi: 10.1111/medu.14314. Epub 2020 Sep 10. No abstract available.

    PMID: 32914443RESULT

  • Real FJ, Ollberding NJ, Meisman AR, DeBlasio DJ, Pero MB, Davis D, Cruse B, Klein MD, Kahn JA, Rosen BL. Impact of a Virtual Reality Curriculum on Human Papillomavirus Vaccination: A Pilot Trial. Am J Prev Med. 2022 Nov;63(5):865-873. doi: 10.1016/j.amepre.2022.05.003. Epub 2022 Jun 29.

    PMID: 35778065RESULT

Results Point of Contact

Title
Dr. Francis Real
Organization
Cincinnati Children's Hospital Medical Center
francis.real@cchmc.org
5136364200

Study Officials

  • F. Joseph Real, MD, MEd

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, University of Cincinnati Department of Pediatrics

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 29, 2020

Study Start

June 23, 2020

Primary Completion

March 31, 2021

Study Completion

December 1, 2022

Last Updated

April 12, 2023

Results First Posted

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)