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Virtual Immersive Communication Training on Recommending Immunizations

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ClinicalTrials.gov Identifier: NCT04368455
Recruitment Status : Suspended (COVID-19)
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Brittany Rosen, Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Behavioral: Virtual Immersive Communication Training on Recommending Immunizations (VICTORI) Behavioral: HPV Same Way Same Day App Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Increasing HPV Vaccination Rates Through Virtual Immersive Communication Training on Recommending Immunizations: An Efficacy Study of VICTORI
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Proportion of patients receiving the HPV vaccination [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Physicians behavioral capability [ Time Frame: 3 months ]
    Physicians behavioral capability for recommendation of the HPV Vaccine following participation in VICTORI.

  2. Physicians self-efficacy [ Time Frame: 3 months ]
    Physicians self-efficacy for recommendation of the HPV Vaccine following participation in VICTORI.

  3. Physicians perceived benefits [ Time Frame: 3 months ]
    Physicians perceived benefits for recommendation of the HPV Vaccine following participation in VICTORI.

  4. Physicians perceived barriers [ Time Frame: 3 months ]
    Physicians self-efficacy for recommendation of the HPV Vaccine following participation in VICTORI.

  5. Physicians perceived risk [ Time Frame: 3 months ]
    Physicians risk of HPV for their patients following participation in VICTORI.

  6. Physicians attitudes toward the HPV vaccine [ Time Frame: 3 months ]
    Physicians attitudes toward the HPV vaccine following participation in VICTORI.

  7. Physicians subjective norms [ Time Frame: 3 months ]
    Physicians subjective norms toward the HPV vaccine following participation in VICTORI.

  8. Physicians strength of recommendation of the HPV vaccine [ Time Frame: 3 months ]
    Physicians strength of recommendation of the HPV vaccine following participation in VICTORI.

  9. Staff benefits and barriers toward recommending the HPV vaccine [ Time Frame: 3 months ]
    Staff benefits and barriers toward recommending the HPV vaccine following participation in VICTORI.

  10. Staff subjective norms toward recommending the HPV vaccine [ Time Frame: 3 months ]
    Staff subjective norms toward recommending the HPV vaccine following participation in VICTORI.

  11. Staff strength of recommendation toward recommending the HPV vaccine [ Time Frame: 3 months ]
    Staff strength of recommendation toward recommending the HPV vaccine following participation in VICTORI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368455


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Brittany Rosen
Investigators
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Principal Investigator: F. Joseph Real, MD, MEd Children's Hospital Medical Center, Cincinnati
Publications:

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Responsible Party: Brittany Rosen, Assistant Professor, University of Cincinnati Department of Pediatrics, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04368455    
Other Study ID Numbers: 2019-0829
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brittany Rosen, Children's Hospital Medical Center, Cincinnati:
Human Papilloma Virus
Human Papilloma Virus Vaccine
Virtual reality
Simulation-based medical education
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs