Virtual Reality Intervention to Support Clinicians' Firearm Safety Counseling Behaviors (REACH_CCTST)

Implementation of a Novel Virtual Reality Intervention to Support Clinicians' Firearm Safety Counseling Behaviors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Virtual Reality; Firearm Injury; Simulation Based Medical Education
• Intervention / Treatment: Behavioral: Resident Education And Counseling on Household Firearm Safety; Behavioral: Modified American Academy of Pediatrics Safer

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; An intervention that includes a self-directed online curriculum and virtual reality simulations, designed to teach firearm screening and counseling among clinicians.; Other Names: REACH 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; An intervention that includes a self-directed online curriculum.; Other Names: Modified AAP Safer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Simulation Based Medical Education; Firearm Injury
• Other Study ID Numbers: 2023-0469

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