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

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

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.

Study Overview

• Status: Completed
• Conditions: Firearm Injury
• Intervention / Treatment: Behavioral: 3-minute BeSMART video; Behavioral: 30-second BeSMART video

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Patient > 9 yo, no video; Caregivers of patients greater than or equal to 10 years old will not be shown a video in the PED.
Active Comparator: Patient > 9 yo, 3 minute video; Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.	Behavioral: 3-minute BeSMART video; 3-minute video focused on education about child gun deaths and responsible gun storage
Experimental: Any age, 30-second video; Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.	Behavioral: 30-second BeSMART video; 30 second video focused on education about child gun deaths and responsible gun storage
Experimental: Any age, 3 minute video; Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.	Behavioral: 3-minute BeSMART video; 3-minute video focused on education about child gun deaths and responsible gun storage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention	Acceptability of the educational videos measured using agreement with the question, "Overall I liked the video". Responses will be on a Likert scale with 1 being the lowest and 5 being the highest.	At baseline
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
Safe Firearm Storage	Self- report based on the survey question, "Are any of the guns in your home kept unlocked?" at baseline. This question has a yes/ no answer.	At baseline
Safe Firearm Storage at Three Months	Self- report at two time points based on the survey question, "Are any of the guns in your home kept unlocked?" at three month follow up; yes/ no answer.	Three month follow up
Knowledge About Temporary Firearm Transfer at Baseline	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) OR ability to name at least one location for temporary firearm storage OR describe the link for a map of storage locations.	At baseline
Knowledge About Temporary Firearm Transfer at Follow up	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.	At study follow-up, an average of three months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Emergency Medicine Foundation; Colorado Clinical & Translational Sciences Institute; American Foundation for Firearm Injury Reduction in Medicine
• Investigators: Principal Investigator: Maya Haasz, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Injury prevention; anticipatory guidance; firearm counseling
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 20-0238; CMH-M-20-15 (Other Grant/Funding Number: Colorado Clinical and Translational Sciences Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No