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Human Papilloma VirusNCT04368455

Virtual Immersive Communication Training on Recommending Immunizations

A study testing Virtual Immersive Communication Training on Recommending Immunizations (VICTORI) and HPV Same Way Same Day App in people with Human Papilloma Virus, run by Brittany Rosen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Papilloma Virus
What is being tested?
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI) and HPV Same Way Same Day App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteUnited States
Study dates
23 Jun 2020to 1 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Increasing HPV Vaccination Rates Through Virtual Immersive Communication Training on Recommending Immunizations: An Efficacy Study of VICTORI

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.

Read the detailed description

Background:

Despite strong evidence the human papillomavirus (HPV) vaccine is effective in preventing certain anogenital cancers, only 65% of adolescent females and 56% of males in the U.S. have initiated the series, and only 43% of girls and 31% of boys have completed it.These rates fall short of Healthy People 2020's objective of 80% coverage for adolescents years of age. Research has demonstrated that the leading predictor of parents' decisions to vaccinate their child against HPV is a strong clinician recommendation.However, evidence suggests that many parents of age-eligible adolescents are not receiving HPV vaccine recommendations or are receiving weak recommendations from clinicians.Previous interventions aimed at increasing HPV vaccination rates have had variable effects in part due to reach and adoption of the interventions within the practices. Also, the diffusion of successful interventions have been limited by lack of scalable designs.Thus, we will solve this limitation by standardizing the training component and moving towards developing a scalable model that translates into consistently improved HPV vaccine rates. Simulation-based medical education (SBME) has become an essential component of clinical training, demonstrating superior effectiveness in teaching a wide range of medical skills compared to conventional training methods. Immersive virtual reality (VR), one type of SBME, is a three-dimensional, computer-generated environment where users interact with graphical characters called avatars. Within VR, a facilitator can design scenarios based on specific behavioral objectives and create environments and avatars based on training needs. The technology facilitates deliberate practice, a personal and goal-oriented approach to skill development derived from Ericsson's Theory on Expertise. In our preliminary study conducted in 2015, we developed an intervention for resident physicians to address influenza vaccine hesitancy, comprised of a self directed application (app) based curriculum about HPV vaccination followed by immersive VR simulations.Completion of the VR simulations, compared to receipt of standard training, led to a significantly lower rate of influenza vaccine refusal.26 Based on these promising preliminary results, we developed VR simulations focused on HPV vaccine counseling.

Purpose:

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. VICTORI will be implemented using a framework informed by behavioral (Social Cognitive Theory, Health Belief Model, and Theory of Planned Behavior) and educational theory (Ericsson's Theory on Expertise). The primary outcome will be an increase in HPV vaccine rates among adolescent patients. We will also assess theory-based mechanisms by which the intervention changes vaccination rates, including clinicians' knowledge, attitudes, perceptions, self-efficacy, and strength of recommendations.

Our long-term goal is to increase HPV vaccination rates in adolescents, which will decrease rates of HPV-associated cancers and pre-cancers. Our short-term objective is to evaluate the efficacy of VICTORI, a novel VR intervention, designed to enhance the strength of clinicians' HPV vaccine recommendations and improve HPV vaccine rates among 11 to 17-year-old patients. To accomplish our objective, we will achieve the following specific aim:

Conduct a single-site intervention assessing the efficacy of VICTORI in increasing HPV vaccine rates. The working hypotheses are: 1) adolescent HPV vaccination rates will increase significantly following implementation of VICTORI compared to pre-intervention rates and 2) this increase will be mediated by clinicians' more positive attitudes, higher self-efficacy, and stronger vaccine recommendations.

Methods:

Clinician participants will receive a self directed app based curriculum prior to the VR simulation, VICTORI. Clinicians will receive education to increase their knowledge of HPV and the vaccine, perceived benefits, positive HPV vaccine attitudes, and subjective norms as well as decrease their perceived barriers to recommending the vaccine. The participants will engage in the VR simulations independently. VICTORI VR simulation implementation sessions will be audio and video recorded. VICTORI's effect will be assessed using a repeated measures pre-post study design with follow-up period. We will collect monthly baseline data on HPV vaccine initiation and completion rates in the clinic for six months prior to implementing VICTORI.We will then collect HPV initiation and completion rates monthly during the time of intervention implementation and for the following six-months.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. Staff will complete a brief pre and immediate post survey assessing their perceived benefits and barriers, subjective norms, and positive messaging about the HPV vaccine. We will collect an additional six months of monthly HPV vaccination initiation and completion data.

Another clinic will serve as en environmental control.Clinician participants at the control site will use the self-directed app based curriculum. Participants will complete the repeated measures pre-post study design with follow-up period. We will collect HPV vaccination data from the other primary care clinic over the same study period to serve as a control.

Implications:

The primary outcome will be the increase in the proportion of patients receiving HPV vaccination seen by resident and attending physicians following participation in VICTORI. Additional secondary outcomes, including physicians' behavioral capability, self-efficacy, perceived benefits, perceived barriers, perceived risk, attitudes, subjective norms, and strength of recommendations, as well as staffs' perceived benefits and barriers, subjective norms, and positive messaging will be assessed via validated survey instruments.

Being tested
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI), HPV Same Way Same Day App
Keywords
Human Papilloma Virus, Human Papilloma Virus Vaccine, Virtual reality, Simulation-based medical education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Immersive Communication Training on Recommending Immunizations (VICTORI)Behavioural

    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.

  • HPV Same Way Same Day AppBehavioural

    An intervention that includes a self-directed app based curriculum

Study groups in NCT04368455
Study groupRoleWhat they receive
Primary Care ClinicExperimentalPhysician 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.
Receives: Behavioral: Virtual Immersive Communication Training on Recommending Immunizations (VICTORI)
Control Primary Care ClinicActive comparatorPhysician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
Receives: Behavioral: HPV Same Way Same Day App

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (5)
  1. Physicians Perceived Barriers

    Physicians level barriers for recommendation of the HPV Vaccine following participation in VICTORI. Sum of 4 survey items using a 4 point scale (minimum score =4, maximum=16). A higher score indicates more barriers.

    Measured: 3 months

  2. Physicians Perceived Risk

    Physicians risk of HPV for their patients following participation in VICTORI. Sum of 5 survey items using a 3 point scale (minimum score =5, maximum=15). A higher score indicates higher perceived risk for patients.

    Measured: 3 months

  3. Physicians Attitudes Toward the HPV Vaccine

    Physicians attitudes toward the HPV vaccine following participation in VICTORI. Sum of 12 survey items using a 5 point scale (minimum score =12, maximum=60). A higher score indicates physician perception of increased importance towards the HPV vaccine.

    Measured: 3 months

  4. Physicians Strength of Recommendation of the HPV Vaccine

    Physicians strength of recommendation of the HPV vaccine following participation in VICTORI. Sum of 8 survey items using a 4 point scale (minimum score =8, maximum=32). A higher score indicates stronger recommendation of HPV vaccine.

    Measured: 3 months

  5. Physicians Self-efficacy

    Physicians self-efficacy for recommendation of the HPV Vaccine following participation in VICTORI. Sum of 5 survey items using a 5 point scale (minimum score =2, maximum=10). A higher score indicates higher self-efficacy.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start23 Jun 2020
  3. Primary completion31 Mar 2021
  4. Study completion1 Dec 2022

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368455
Sponsor's protocol ID
2019-0829
Other IDs
5R21CA238170-02
Status last verified
Mar 2023
First submitted
27 Apr 2020
Last updated
12 Apr 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30932718
  • 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.

    PubMed 29453187
  • 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.

    PubMed 29502639
  • 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.

    PubMed 29204462
  • 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.

    PubMed 29786025
  • 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.

    PubMed 28126612
  • 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.

    PubMed 32914443
  • 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.

    PubMed 35778065

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Immersive Communication Training on Recommending Immunizations (VICTORI) and HPV Same Way Same Day App in people with Human Papilloma Virus, run by Brittany Rosen 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 1 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 12 Apr 2023. 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?

Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation (time frame: 6 months). 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 NCT04368455, which also lists 8 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 12 Apr 2023.

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