CClinicalTrials.gg
Active, not recruitingNCT06108141REACH_CCTSTUpdated Jun 27, 2024

Virtual Reality Intervention to Support Clinicians' Firearm Safety Counseling Behaviors

An interventional study of Resident Education And Counseling on Household Firearm Safety and Modified American Academy of Pediatrics Safer in Virtual Reality, Simulation Based Medical Education and Firearm Injury, sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to assess the efficacy of REACH Firearm Safety in a sample of pediatric residents. The main question it aims to answer are:

Do residents who have completed REACH Firearm Safety have increased documentation in the electronic medical records for screening and counseling for safe firearm storage?

Participants will be asked to engage in a virtual reality curriculum (REACH Firearm Safety). Researchers will compare the REACH Firearm safety group to a group of participants who complete an abbreviated online training.

Read the detailed description

The American Academy of Pediatrics urges pediatricians to counsel parents on the dangers of childhood access to firearms and restrict access through safe storage practices. However, evidence suggests that most pediatricians do not provide firearm-related counseling in real-world clinical practice. This is notable as firearm-related injury is now the leading cause of death in children aged 1-19 years in the United States. Virtual reality (VR) is a type of simulation-based medical education that allows users to interact with virtual environments and characters in a seemingly realistic way. Investigators developed Resident Education And Counseling on Household (REACH) Firearm Safety, a VR curriculum to allow pediatricians to practice screening and counseling on firearm safety. The objective of this proposal is to assess the efficacy of REACH Firearm Safety, along with key implementation metrics, to justify and inform scale and distribution of the training approach. To achieve the objective, Investigators will: (1) Conduct a multi-site two-arm randomized controlled pilot study assessing the efficacy of REACH Firearm Safety and (2) Measure acceptability, appropriateness, fidelity, feasibility, and cost of implementation of REACH Firearm Safety. The proposed research is significant and innovative because it is the first rigorous effort to evaluate the efficacy of VR as a training platform to teach communication skills related to firearm safety counseling.

02

Conditions studied

  • Virtual Reality
  • Simulation Based Medical Education
  • Firearm Injury

Keywords

  • Virtual Reality
  • Simulation Based Medical Education
  • Firearm Injury
03

In context

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Resident with continuity clinic at either Kentucky Clinic South, University of Kentucky (UK) Internal Medicine and Pediatrics group, CCHMC Hopple Street Neighborhood Health Center, or University of Cincinnati (UC) Hoxworth Medicine-Pediatrics Clinic

Exclusion criteria

Exclusion Criteria:

  • Resident unable to read or speak English
  • Resident with continuity clinic outside of inclusion criteria clinics
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Resident Education And Counseling on Household (REACH) Firearm Safety

    Resident participants will complete a modified online self-guided American Academy of Pediatrics (AAP) Safer curriculum. Next, residents will complete REACH individually with a trained facilitator.

    Behavioral: Resident Education And Counseling on Household Firearm Safety

  • Active comparator
    Modified AAP Safer

    Resident participants will complete a modified online self-guided American Academy of Pediatrics (AAP) Safer curriculum.

    Behavioral: Modified American Academy of Pediatrics Safer

Interventions

  • BehavioralResident Education And Counseling on Household Firearm Safety

    An intervention that includes a self-directed online curriculum and virtual reality simulations, designed to teach firearm screening and counseling among clinicians.

    Also known as: REACH Firearm Safety

  • BehavioralModified American Academy of Pediatrics Safer

    An intervention that includes a self-directed online curriculum.

    Also known as: Modified AAP Safer

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in the Percentage of Participants with documentation within the medical record of access to firearms.

    Documentation of discussion during clinical encounter of access to firearms.

    Time frame: 6 months

  2. Percent Change From Baseline in the Percentage of Participants with documentation within the medical record of counseling on firearm injury prevention.

    Documentation of discussion during clinical encounter of firearm injury prevention.

    Time frame: 6 months

07

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06108141
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
F. Joseph Real (Associate Professor, Children's Hospital Medical Center, Cincinnati) — Principal investigator
First posted
Oct 30, 2023
Start date
Dec 19, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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