Virtual Immersive Communication Training on Recommending Immunizations

March 18, 2023 updated by: Brittany Rosen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Care Clinic
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)
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.
Active Comparator: Control Primary Care Clinic
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
An intervention that includes a self-directed app based curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physicians Perceived Barriers
Time Frame: 3 months
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.
3 months
Physicians Perceived Risk
Time Frame: 3 months
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.
3 months
Physicians Attitudes Toward the HPV Vaccine
Time Frame: 3 months
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.
3 months
Physicians Strength of Recommendation of the HPV Vaccine
Time Frame: 3 months
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.
3 months
Physicians Self-efficacy
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brittany Rosen

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: F. Joseph Real, MD, MEd, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 18, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0829
  • 5R21CA238170-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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