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Clinical Trials/NCT04368455
NCT04368455CompletedNot Applicable

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

Brittany Rosen1 site in 1 country161 target enrollmentStarted: June 23, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
161
Locations
1
Primary Endpoint
Percent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

  • Not provided

Arms & Interventions

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.

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

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.

Intervention: HPV Same Way Same Day App (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: 6 months

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

Secondary Outcomes

  • Physicians Self-efficacy(3 months)
  • Physicians Attitudes Toward the HPV Vaccine(3 months)
  • Physicians Perceived Barriers(3 months)
  • Physicians Strength of Recommendation of the HPV Vaccine(3 months)
  • Physicians Perceived Risk(3 months)

Investigators

Sponsor
Brittany Rosen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Brittany Rosen

Assistant Professor, University of Cincinnati Department of Pediatrics

Children's Hospital Medical Center, Cincinnati

Study Sites (1)

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