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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06108141
Other study ID # 2023-0469
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 19, 2023
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source Children's Hospital Medical Center, Cincinnati
Contact Francis Real, MD, MEd
Phone 484-716-3867
Email francis.real@cchmc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date June 30, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Modified American Academy of Pediatrics Safer
An intervention that includes a self-directed online curriculum.

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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