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

Primary Purpose

Firearm Injury

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
30-second BeSMART video
3-minute BeSMART video
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Firearm Injury focused on measuring Injury prevention, anticipatory guidance, firearm counseling

Eligibility Criteria

30 Days - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Experimental

Experimental

Arm Label

Patient > 9 yo, no video

Patient > 9 yo, 3 minute video

Any age, 30-second video

Any age, 3 minute video

Arm Description

Caregivers of patients greater than or equal to 10 years old will not be shown a video in the PED.

Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.

Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.

Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2021
Last Updated
December 8, 2021
Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute, Emergency Medicine Foundation, American Foundation for Firearm Injury Reduction in Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05168878
Brief Title
Safety Education in the Emergency Department: A Pilot Study
Acronym
SEED
Official Title
Safety Education in the Emergency Department (SEED): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute, Emergency Medicine Foundation, American Foundation for Firearm Injury Reduction in Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Firearm Injury
Keywords
Injury prevention, anticipatory guidance, firearm counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient > 9 yo, no video
Arm Type
No Intervention
Arm Description
Caregivers of patients greater than or equal to 10 years old will not be shown a video in the PED.
Arm Title
Patient > 9 yo, 3 minute video
Arm Type
Active Comparator
Arm Description
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
Arm Title
Any age, 30-second video
Arm Type
Experimental
Arm Description
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
Arm Title
Any age, 3 minute video
Arm Type
Experimental
Arm Description
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
Intervention Type
Behavioral
Intervention Name(s)
30-second BeSMART video
Intervention Description
30 second video focused on education about child gun deaths and responsible gun storage
Intervention Type
Behavioral
Intervention Name(s)
3-minute BeSMART video
Intervention Description
3-minute video focused on education about child gun deaths and responsible gun storage
Primary Outcome Measure Information:
Title
Acceptability of intervention
Description
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.
Time Frame
Through study completion, an average of three months
Title
Feasibility of follow up
Description
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.
Time Frame
Through study completion, an average of three months
Title
Safe firearm storage
Description
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.
Time Frame
Through study completion, an average of three months
Title
Knowledge about firearm transfer
Description
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.
Time Frame
Through study completion, an average of three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Haasz, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Education in the Emergency Department: A Pilot Study

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