search
Back to results

Virtual Immersive Communication Training on Recommending Immunizations

Primary Purpose

Human Papilloma Virus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI)
HPV Same Way Same Day App
Sponsored by
Brittany Rosen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Human Papilloma Virus focused on measuring Human Papilloma Virus, Human Papilloma Virus Vaccine, Virtual reality, Simulation-based medical education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primary Care Clinic

Control Primary Care Clinic

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 27, 2020
Last Updated
March 18, 2023
Sponsor
Brittany Rosen
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04368455
Brief Title
Virtual Immersive Communication Training on Recommending Immunizations
Official Title
Increasing HPV Vaccination Rates Through Virtual Immersive Communication Training on Recommending Immunizations: An Efficacy Study of VICTORI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brittany Rosen
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
Human Papilloma Virus, Human Papilloma Virus Vaccine, Virtual reality, Simulation-based medical education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Care Clinic
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Primary Care Clinic
Arm Type
Active Comparator
Arm Description
Physician participants will receive the self-directed app based curriculum component of VICTORI though will not undergo the VR simulations.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Immersive Communication Training on Recommending Immunizations (VICTORI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HPV Same Way Same Day App
Intervention Description
An intervention that includes a self-directed app based curriculum
Primary Outcome Measure Information:
Title
Percent Change From Baseline in the Percentage of Participants With HPV Vaccine Initiation
Description
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
Secondary Outcome Measure Information:
Title
Physicians Perceived Barriers
Description
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
Title
Physicians Perceived Risk
Description
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
Title
Physicians Attitudes Toward the HPV Vaccine
Description
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
Title
Physicians Strength of Recommendation of the HPV Vaccine
Description
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
Title
Physicians Self-efficacy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physician (Attending or Resident) at control or intervention clinic Staff Member (Medical Assistant or Nurse) at intervention clinic Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Joseph Real, MD, MEd
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30932718
Citation
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.
Results Reference
background
PubMed Identifier
29453187
Citation
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.
Results Reference
background
PubMed Identifier
29502639
Citation
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.
Results Reference
background
PubMed Identifier
29204462
Citation
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.
Results Reference
background
PubMed Identifier
29786025
Citation
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.
Results Reference
background
PubMed Identifier
28126612
Citation
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.
Results Reference
background
PubMed Identifier
32914443
Citation
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.
Results Reference
result
PubMed Identifier
35778065
Citation
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.
Results Reference
result

Learn more about this trial

Virtual Immersive Communication Training on Recommending Immunizations

We'll reach out to this number within 24 hrs