Safety Education in the Emergency Department: A Pilot Study

Firearm Injury Clinical Trial

— SEED  

Official title:

Safety Education in the Emergency Department (SEED): A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05168878
• Other study ID #: 20-0238
• Secondary ID: CMH-M-20-15
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to assess the feasibility and acceptability of video-based safe firearm storage education in the Pediatric Emergency Department.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion criteria:

• Children > 30 days and < 18 years old presenting to the CHCO ED

• Parent/guardian who is = 18 and = 85 years old

• Arms 1 & 2 will include a subset of patients =10 years and < 18 years old with a firearm in the home.

Exclusion criteria:

• Child is in an emergent/acute medical condition

• Patient seen in our fast track area or other room without a television

• Parent/guardian is non-English speaking.

Related Conditions & MeSH terms

• Emergencies
• Firearm Injury

Intervention

Behavioral:
• 30-second BeSMART video
30 second video focused on education about child gun deaths and responsible gun storage
• 3-minute BeSMART video
3-minute video focused on education about child gun deaths and responsible gun storage

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Foundation for Firearm Injury Reduction in Medicine, Colorado Clinical & Translational Sciences Institute, Emergency Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of intervention	Acceptability of the educational videos measured using a survey with question, "How useful was the information you received?" and "Was the information you received confusing?". Responses will be on a ilkert scale with 1 being the lowest and 5 being the highest.	Through study completion, an average of three months
Primary	Feasibility of follow up	Feasibility of completing a follow up survey with parents within 3 months after the intervention measured by the proportion of caregivers who complete the survey in its entirety either electronically or by phone.	Through study completion, an average of three months
Primary	Safe firearm storage	Self- report at two time points based on the survey questions, "Are any of the guns in your home kept unlocked?", and "Are the bullets stored separately from the guns?". Both questions have yes/ no answers.	Through study completion, an average of three months
Primary	Knowledge about firearm transfer	Parental awareness of temporary firearm transfer will be measured by self-report based on question, "Did you know that you can temporarily take your guns out of your home if you are concerned that someone in your house may hurt themselves or someone else?". (responses answers are yes or no) and ability to name at least one location for temporary firearm storage OR describe the link for a map of storage locations.	Through study completion, an average of three months