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Virtual Immersive Communication Training on Recommending Immunizations

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04368455
Enrollment
161
Registered
2020-04-29
Start date
2020-06-23
Completion date
2022-12-01
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus

Keywords

Human Papilloma Virus, Human Papilloma Virus Vaccine, Virtual reality, Simulation-based medical education

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.

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.

Interventions

BEHAVIORALVirtual Immersive Communication Training on Recommending Immunizations (VICTORI)

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.

BEHAVIORALHPV Same Way Same Day App

An intervention that includes a self-directed app based curriculum

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Brittany Rosen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Percent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation6 monthsThe primary outcome was the percent change from pre versus post VICTORI in rates of HPV vaccine initiation among eligible patients presenting to clinic.

Secondary

MeasureTime frameDescription
Physicians Perceived Barriers3 monthsPhysicians 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.
Physicians Perceived Risk3 monthsPhysicians 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.
Physicians Attitudes Toward the HPV Vaccine3 monthsPhysicians 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.
Physicians Strength of Recommendation of the HPV Vaccine3 monthsPhysicians 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.
Physicians Self-efficacy3 monthsPhysicians 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Primary Care Clinic- Physicians
Physician participants will receive the self-directed app based curriculum. The physician participants will engage in the Virtual Reality (VR) simulations independently. Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of human papillomavirus (HPV) vaccine recommendations among clinicians.
88
Primary Care Clinic- Staff
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. Virtual Immersive Communication Training on Recommending Immunizations (VICTORI): 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.
27
Control Primary Care Clinic
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations. HPV Same Way Same Day App: An intervention that includes a self-directed app based curriculum
29
Total144

Baseline characteristics

CharacteristicPrimary Care Clinic- PhysiciansPrimary Care Clinic- StaffControl Primary Care ClinicTotal
Age, Continuous30.1 years
STANDARD_DEVIATION 6
38.4 years
STANDARD_DEVIATION 10.8
32.3 years
STANDARD_DEVIATION 9.4
32.6 years
STANDARD_DEVIATION 8.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
87 Participants26 Participants29 Participants142 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
10 Participants0 Participants1 Participants11 Participants
Race (NIH/OMB)
Black or African American
5 Participants7 Participants3 Participants15 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants2 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants1 Participants3 Participants9 Participants
Race (NIH/OMB)
White
66 Participants16 Participants20 Participants102 Participants
Sex: Female, Male
Female
59 Participants27 Participants17 Participants103 Participants
Sex: Female, Male
Male
29 Participants0 Participants12 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 880 / 270 / 29
other
Total, other adverse events
0 / 880 / 270 / 29
serious
Total, serious adverse events
0 / 880 / 270 / 29

Outcome results

Primary

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.

Time frame: 6 months

Population: The electronic health record was used to identify patients' HPV vaccine initiation rates for participating physicians at the intervention and control sites. The pre-intervention period was 6 months before VICTORI and app-based training implementation (February 1, 2020-July 31, 2020), and the post-intervention period was 6 months following implementation (October 1, 2020-March 31, 2021). The primary outcome was the change in rates of HPV vaccine initiation pre vs post the VICTORI intervention.

ArmMeasureValue (NUMBER)
Primary Care ClinicPercent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation18.1 Percent Change from Baseline
Control Primary Care ClinicPercent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation3.9 Percent Change from Baseline
Secondary

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.

Time frame: 3 months

Population: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care ClinicPhysicians Attitudes Toward the HPV VaccinePre-VICTORI49.68 score on a scaleStandard Deviation 8.73
Primary Care ClinicPhysicians Attitudes Toward the HPV VaccinePost-VICTORI54.24 score on a scaleStandard Deviation 6.28
Primary Care ClinicPhysicians Attitudes Toward the HPV Vaccine3-Month Post-VICTORI53.15 score on a scaleStandard Deviation 7.19
Secondary

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.

Time frame: 3 months

Population: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care ClinicPhysicians Perceived BarriersPost-VICTORI6.87 score on a scaleStandard Deviation 1.66
Primary Care ClinicPhysicians Perceived Barriers3-Month Post- VICTORI6.75 score on a scaleStandard Deviation 1.59
Primary Care ClinicPhysicians Perceived BarriersPre-VICTORI7.39 score on a scaleStandard Deviation 1.67
Secondary

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.

Time frame: 3 months

Population: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care ClinicPhysicians Perceived RiskPre-VICTORI10.53 score on a scaleStandard Deviation 2.43
Primary Care ClinicPhysicians Perceived RiskPost-VICTORI12.07 score on a scaleStandard Deviation 2.26
Primary Care ClinicPhysicians Perceived Risk3 Month Post-VICTORI11.36 score on a scaleStandard Deviation 2.36
Secondary

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.

Time frame: 3 months

Population: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care ClinicPhysicians Self-efficacyPre-VICTORI7.44 score on a scaleStandard Deviation 1.27
Primary Care ClinicPhysicians Self-efficacyPost- VICTORI9.55 score on a scaleStandard Deviation 0.76
Primary Care ClinicPhysicians Self-efficacy3-Month Post-VICTORI9.27 score on a scaleStandard Deviation 0.88
Secondary

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.

Time frame: 3 months

Population: Secondary outcomes analyzed related to impact of curriculum over time rather than analyses compared to control participants.

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care ClinicPhysicians Strength of Recommendation of the HPV VaccinePre-VICTORI28.49 score on a scaleStandard Deviation 3.37
Primary Care ClinicPhysicians Strength of Recommendation of the HPV VaccinePost-VICTORI28.76 score on a scaleStandard Deviation 2.53
Primary Care ClinicPhysicians Strength of Recommendation of the HPV Vaccine3-Month Post-VICTORI29.17 score on a scaleStandard Deviation 2.35

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026