Safety Education in the Emergency Department (SEED): A Pilot Study
Phase: NA
Conditions: Firearm Injury
Sponsor: University of Colorado, Denver

Title Page 
Title: Safety Education in the Emergency Department: A Pilot Study 
Identifier: NCT05168878  
Document date: April 17, 2020

 
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COMIRB # 20-0238 
PI: Maya Haasz, MD 
Protocol version: 04/17/2020 
w 
COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
 
Protocol #: 20-0238 
Project Title: Safety Education in the Emergency Department (SEED): A pilot study  
Principal Investigator: Maya Haasz, MD 
Version Date: 04/17/2020 
 
 
I. Hypothesis and specific aims 
 
The goal of this proposal is to determine the feasibility and acceptability of using a video in the 
Emergency Department (ED) at the Children’s Hospital Colorado (CHCO) to promote the safe storage of 
firearms, and safe firearm behaviors, in homes with children. We also intend to obtain pilot data to 
evaluate parental storage practices and knowledge surrounding temporary firearm transfer out of the 
home in times of crisis and determine whether these can be improved following a standardized ED 
intervention. Our overall hypothesis is that presenting a video during a child’s ED stay will improve 
communication with the ED provider ultimately increasing safe firearm storage. In order to test this 
hypothesis, we are proposing a pilot study to test the feasibility,acceptability and effectiveness of a 
video intervention in the ED with the following aims: 
 
Aim 1: Aim 1: Evaluate the effectiveness of safe firearm storage education for medical and surgical 
patients in the Children’s Hospital Colorado (CHCO) ED by measuring change in self-reported safe 
storage at baseline and 3 months after a brief ED intervention. 
 
Hypothesis: Safe storage counselling will improve safe storage practices by 15% over baseline rates, as 
measured by removing all guns from home or locking all guns and locking ammunition separately.  
 
Aim 2: Evaluate the effectiveness of a brief ED intervention in improving parental knowledge 
surrounding temporary firearm transfer out of the home as a lethal means restriction strategy by 
measuring parental knowledge at baseline and 3 months after a brief ED intervention. 
 
Hypothesis: Parents will not be aware of temporary firearm storage as a lethal means restriction 
strategy, and an ED intervention will be effective at improving this knowledge. 
 
Aim 3: Compare the feasibility of having parents watch a short, 30-second, to a long, 3-minute, Be 
SMART firearm safety video in the CHCO ED. 
 
Hypothesis: We believe that at least 10% more parents will complete watching the 30 second video 
compared with the 3-minute video as measured by data retrieved from the GetWell network. 
 

 
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Aim 4: Evaluate the acceptability of both videos to parents who view the video with a post-test survey 
administered in the ED using a survey modified from previous work done at our institution [1]. 
 
Hypothesis: We expect that the video will be acceptable to 75% of parents who view the video. 
 
Aim 5: Assess the number of parents that participate in a follow up survey within 3 months after the ED 
visit. 
 
Hypothesis: We hypothesize that 65% of parents will complete the entire follow-up survey. 
 
 
This study is the first step in determining if offering a firearm safety video focused on safe 
storage in the ED is feasible and acceptable to our parents, and whether it is effective in a subset of 
families with older children known to have firearms in the home. The results generated from this study 
will lead to evaluating the effectiveness of the video at changing firearm storage and safety behaviors 
among a larger population of families. Given that we see 75,000 patients annually in our ED, we have 
the infrastructure in place to test this pilot study and future interventions. If effective, we also have the 
infrastructure to support broad implementation, including to our network sites, reaching a sizable and 
diverse population of Colorado families. 
 
II. Background and significance 
Firearm injuries, both intentional and unintentional, are a public health crisis in the United States. 
Among children and adolescents nationally, firearm related injuries are the second leading cause of 
death, accounting for more than 15% of all fatalities in individuals age 1-19 years old, and  [2]. The intent 
of injury varies with age, with 26% of firearm deaths among children (1-9 years old) being unintentional 
[2]. In contrast, among adolescents (10-19 years old), nearly all deaths - 97% - were intentional with 39% 
due to suicide [2].  Suicide is of even greater concern in Colorado, which is the state with the 10th 
highest suicide rate in the country with a rate of 20 suicide deaths per 100,000 population, well above 
the national average of 14 per 100,000 [3]. 
The American Academy of Pediatrics (AAP) recommends storing firearms locked, unloaded, and 
separate from ammunition [4]. Each of these measures has proven protective against unintentional 
injuries and suicide by firearm in youth [5]. This effect on suicide attempt by firearm is critical as the use 
of lethal means plays a crucial role in whether an individual completes suicide [6]. Firearms are the most 
lethal means of suicide with a fatality rate of 90% [7], accounting for 54% of suicide deaths even though 
they were used in only 6% of attempts [8].  
Firearms are only safely stored in one third of homes with children [9, 10]. This, despite most 
unintentional injuries being caused by a gun found in the home [11], and evidence that children cannot 
be “taught” firearm safety at a young age, playing with guns even when warned not to [12]. There is no 
improvement in storage practices in homes of children who are at higher risk for suicide [13]. Easy 
availability of firearms in the home correlates significantly with adolescent suicide rates, with 80% of 
youth suicides occurring in their home, most commonly with a parent’s firearm [14]. In most of these 
cases, the firearms were not stored per recommended safe storage practices [5]. 
Improving rates of safe storage in homes with children and adolescents, thus decreasing access to 
firearms for this age group, is essential to decreasing firearm morbidity and mortality. The challenge lies 
in identifying the best mode and setting by which to communicate this to families. The ED is uniquely 
positioned to reach a broad population with an educational intervention. Pediatricians are excellent 
candidates to deliver this safety message as child health advocates, and do so effectively in the primary 

 
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care setting [15]. This message is also effective in the ED for patients who require evaluation for active 
suicidality. In this context, a five-minute intervention by a psychiatrist and provision of a lockbox proved 
effective at improving safe firearm storage and decreasing access to lethal means in patients at high-risk 
for suicide [1].  
The aspect of the ED which makes it an excellent setting, in that patients are primed for safety 
education and providers are natural advocates, also presents challenges. Generally, providers spend less 
time with the patient and the physician-patient relationship is not as well developed as in primary care. 
In addition, ED resources are inadequate and providers too numerous to generalize in-person 
counselling.  
Video-based patient education is effective in engaging and educating patients in other settings and 
topic areas [16], and is frequently used at CHCO to educate families about medical diagnoses or child 
safety. We expect an educational video to be an effective mechanism to provide firearm safety 
education in the ED as it is brief, reproducible, and obviates the need to train providers or utilize 
additional provider time.  
The Be SMART campaign , developed by Everytown for Gun Safety, has developed firearm safety 
videos based on their messaging of “Secure all guns in your home and vehicle, Model responsible 
behavior, Ask about the presence of unsecured guns in other homes, Recognize the role of guns in 
suicide, Tell your peers to be SMART” [17] – one 30-second video and a second 3-minute video. This 
framework is applicable to individuals regardless of firearm ownership. It is currently being studied as an 
educational model at a small number of pediatric inpatient units and primary care settings across the 
country. We do not know, however, if it is feasible to show these videos to parents of patients 
presenting to the ED, if the messaging will be acceptable in our population, or if they are an effective 
means of changing behavior. 
We intend to address a portion of this knowledge gap with this pilot study to demonstrate the 
feasibility of 1) showing the video in the ED and 2) whether parents will participate in a 3-month up 
phone call to evaluate for improvement in safe firearm behaviors. We will evaluate the acceptability of 
the video using a modified version of a survey previously used at our institution [1]. In a subset of the 
population who are firearm owners, thus at higher risk, we will collect pilot data to understand whether 
this video, coupled with a handout, appears to be effective. If feasible and acceptable, we will seek to 
evaluate the effectiveness of the video, and compare the effectiveness of the two videos, via a 
randomized control trial.  
 
III.  Research Methods 
 
A.  Outcome Measure(s):   
Specific aims 1 and 2: 
Primary outcome measures: 
1) Safe firearm storage will be measured by self- report based on the survey questions such as, 
“Are any of the guns in your home kept unlocked?”, and “Are the bullets stored separately from 
the guns?”.  
2) Parental awareness of temporary firearm transfer will be measured by self-report based on 
questions such as, “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. 
3) Parental knowledge of temporary firearm storage options will be measured by the ability to 
name at least one location for temporary firearm storage OR describe the link for a map of 
storage locations. 

 
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Specific aims 1-5: 
4) Feasibility of delivering the intervention in the Emergency Department (ED) measured by  
a. Proportion of caregivers approached who agree to participate in the study. 
b. Proportion of caregivers who complete the video in its entirety, based on data provided 
by the GetWell network who will be hosting the video content. 
c. Proportion of caregivers who complete the baseline survey, which will ask questions 
about general child safety behaviors, current firearm storage, acceptability of video 
content and acceptability of showing the video during the ED visit. 
5) Acceptability of the educational videos as measured using a survey at baseline with primarily 
closed-ended questions such as “How useful was the information you received?” and “Was the 
information you received confusing?”. There will also be an open-ended question to solicit 
additional feedback 
6) 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. 
 
B. Description of Population to be Enrolled:   
Inclusion criteria: 
1. Children > 30 days and < 18 years old presenting to the CHCO ED 
2. Parent/guardian who is ≥ 18 and ≤ 85 years old 
3. Specific aims 1 & 2 will include a subset of patients 10 years and < 18 years old with a firearm in 
the home. 
 
Exclusion criteria:  
1. Child is in an emergent/acute medical condition 
2. Patient seen in our fast track area or other room without a television 
3. Parent/guardian is non-English speaking. 
 
 
For specific aims 1 and 2: Professional Research Assistants (PRAs) that staff the ED from 7am to 
midnight, 7 days per week will screen families, and approach any family with a child 10 years to < 18 
years old to participate in a safety study. Caregivers who agree to participate will be asked to complete 
the first 10 questions of the baseline survey about child safety, including a question about firearm 
ownership and storage, on an iPad. Caregivers who answer the question “Are any of the guns in your 
home kept unlocked?” with “yes”, “no”, or “I don’t know” will be included in the study. Those who 
answer “There are no guns in the home” will be excluded. Those included will complete the baseline 
survey.  
 
For specific aims 3, 4 and 5: Professional Research Assistants (PRAs) that staff the ED from 7am 
to midnight, 7 days per week will screen families, and approach any family with a child 17 years or 
younger to watch a video about child safety. Caregivers who agree to participate will be asked to 
complete the first part of the baseline survey about child safety in general, including questions about 
firearm ownership and storage, on an iPad. Caregivers will then be randomized to watch either the 30-
second or 3-minute Be SMART video. Following the video, caregivers will be asked to complete the 
second part of the baseline survey, also on an iPad, which will address acceptability of the video. In this 
part of the study, we will not restrict inclusion based on endorsed firearm ownership because it may be 
underreported, and we may miss messaging potential firearm owners. Additionally, the video includes 

 
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messaging about safe firearm behaviors that are more universally applicable, such as asking about 
firearms in other homes that children frequent. 
 
C. Study Design and Research Methods   
 
This will be an experimental pre-post pilot study performed in the ED at CHCO. Patients 
presenting to the ED with a non-emergent complaint will be screened by PRAs or the Principal 
Investigator and approached to participate after they are assigned an ED room and prior to leaving the 
room due to discharge, transfer or admission. Since this study is observational in nature, participation 
will not alter medical treatment or length of stay in the ED; therefore, after caregivers review a postcard 
consent about the study, they will be asked to answer a question in REDCap indicating if they agree to 
participate. If the child is of assenting age (7-17), we will have the child review a postcard assent about 
the study.  They will then be asked to answer a question in REDCap indicating if they agree to 
participate.  The postcard consent/assent will describe our goal as studying child safety in general and 
will not specifically refer to a firearm safety objective, in order to mitigate potential bias. We will debrief 
the caregiver about the minor deception after they complete the follow-up survey, as knowledge of 
study aims could bias answers to both the baseline and follow up survey. 
 
Specific aims 1 and 2: To prevent potential contamination across providers in the ED, the 
intervention will only be given during one block of time. Families will be block randomized by date of 
presentation. In the first six months, or until we recruit the necessary number of participants, we will 
provide current standard of care with no new intervention – this will be group 1 (G1). In the following six 
months we will recruit into the intervention group – this will be group 2 (G2).  In G1, parents will 
complete the baseline survey at time 0 (t0) and will complete the follow-up survey at 3 months (t3) via 
follow up phone call. In G2, parents will be asked to complete the baseline survey at t0 and will then be 
asked to watch the 3-minute Be SMART video. Parents in G2 will also complete the follow-up survey at 
t3 via follow up phone call.  
 
Specific aims 3, 4 and 5: Those answer yes in REDCap indicating that they agree to participation 
will be randomized to watch either the 30-second or 3-minute Be SMART video.  Each family enrolled 
will be asked to watch one of these two videos.  
 
For all aims: The videos have been developed by  “Be SMART” [17], an organization focused on 
responsible gun storage education and awareness. These videos describe safe firearm storage in the 
home, encourage parents to ask about firearm storage at homes their children frequent, and addresses 
removing firearms from the home if someone is having a mental health crisis. This messaging is 
applicable both to owners and non-owners of firearms. In addition, demographic information including 
subject’s name, age, sex, parents’ names, email addresses and telephone numbers will be collected. 
Clinical variables, such as presence or absence of mental health diagnoses, abuse, current presentation 
with mental health complaint, active suicidal or homicidal ideation and presentation with penetrating 
trauma, will also be collected from the electronic medical record (EMR) by the PI or other study 
investigators after the index visit.  
 
Participants will be given a brief survey prior to the video to assess baseline storage habits along 
with other child safety behaviors.All families will also complete a survey immediately after the video to 
evaluate acceptability of the video. Participants will also receive a follow-up email or phone call to 
evaluate storage habits and firearm safety behaviors within 3 months after their visit. If we are unable to 
contact the family by email or phone, we will consider them a lost to follow-up (LTFU). For aims 1 and 2, 
we will give each family a $5.00 gift card for participation in the study at the initial visit.  For aims 3, 4 

 
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and 5, we will give each family up to a $20 gift card for participation in the study - $10 after watching the 
video and completing both parts of the baseline survey, and $10 after completing the follow up survey. 
 
Data from each subject will be entered into a REDCap database on a secure server.  All 
identifiers will be removed from the data set after all participation is complete, including follow up, 
before data analysis.  EMR review will occur after the index visit. Study investigators will manually 
review charts for descriptive and clinical characteristics. Each of these subjects’ will already be 
registered in the secure REDCap database under a specific study number at the time of retrospective 
review and data will be entered here. 
 
E.   Description, Risks and Justification of Procedures and Data Collection Tools: 
 
The study will consist of watching a brief video and responding to questions pertaining to 
pediatric safety. This intervention will not impact medical care or time spent in the ED in any way. 
Demographic characteristics to be recorded include age, sex, and race/ ethnicity of the child. Medical 
history and clinical variables will be collected such as presence or absence of mental health diagnoses, 
abuse, current presentation with mental health complaint, active suicidal or homicidal ideation and 
presentation with penetrating trauma.  
 
The following measures will be taken in order to minimize the risk of breach of confidentiality 
that is always a concern with collection of protected health information (PHI).  Each subject will be 
assigned a unique study number and all patient identifiers will be removed from the data set after 
participation is complete, including follow up, and before data analysis.  All data including PHI will be 
stored in REDCap. (The UCD REDCap installation passed a rigorous 6-week security threat analysis 
performed by the UCD-Anschutz HIPAA Security Officer.  All study data are stored on a secure database 
server which is separate from the web-facing server -- a best-practices for internet-based security. All 
user access requires user accounts and passwords. All user actions are recorded in a secure audit log. 
The database server is routinely backed-up. All security patches and application updates are applied 
immediately upon release by DISC.) Upon completion of the study, all patient identifiers in the data set 
will be removed. 
 
F.   Potential Scientific Problems:   
 
The goal of this pilot study is to assess feasibility and acceptability of showing a firearm safety 
video in the ED, with the goal of a larger scale study to evaluate whether this video can improve storage 
practices and improve other firearm safety behaviors. 
 
G.   Data Analysis Plan:   
 
We will collect demographic data from the patient’s electronic medical record as well as survey 
results from the parent-completed survey. 
 
Continuous variables will be described as means and standard deviations if normally distributed 
or median and interquartile range if non-normally distributed. Categorical variables will be described 
using counts and percentages. We will compare data between families who received the 30-second 
video and the 3-minute video using fisher exact tests, t-tests, or Wilcoxon rank sum tests as appropriate. 
All results will be presented in aggregate and performed in SAS (Cary, NC). 
 
H.  Summarize Knowledge to be Gained:   

 
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This study has the potential to utilize a novel approach to educating the public 
about safe firearm storage. If successful, it can improve rates of safe firearm storage where 
children and adolescents are living and increase safe firearm behaviors, thereby reducing 
morbidity and mortality caused by suicide, unintentional injuries, and assaults.  
 
 
I. References 
1. 
Runyan, C.W., et al., Lethal Means Counseling for Parents of Youth Seeking Emergency Care for 
Suicidality. West J Emerg Med, 2016. 17(1): p. 8-14. 
2. 
Cunningham, R.M., M.A. Walton, and P.M. Carter, The Major Causes of Death in Children and 
Adolescents in the United States. N Engl J Med, 2018. 379(25): p. 2468-2475. 
3. 
National Center for Health Statistics, C.f.D.C.a.P. Stats of the State of Colorado. April 13, 2018 
[cited Sept 9 2019]; Available from: 
https://www.cdc.gov/nchs/pressroom/states/colorado/colorado.htm. 
4. 
Pediatric Patient Education, A.A.o.P. Firearms Injury Prevention.  [cited 2019 September 12]; 
Available from: https://patiented.solutions.aap.org/handout.aspx?gbosid=166212. 
5. 
Grossman, D.C., et al., Gun storage practices and risk of youth suicide and unintentional firearm 
injuries. JAMA, 2005. 293(6): p. 707-14. 
6. 
Simon, O.R., et al., Characteristics of impulsive suicide attempts and attempters. Suicide Life 
Threat Behav, 2001. 32(1 Suppl): p. 49-59. 
7. 
Elnour, A.A. and J. Harrison, Lethality of suicide methods. Inj Prev, 2008. 14(1): p. 39-45. 
8. 
Spicer, R.S. and T.R. Miller, Suicide acts in 8 states: incidence and case fatality rates by 
demographics and method. Am J Public Health, 2000. 90(12): p. 1885-91. 
9. 
Azrael, D., et al., Firearm Storage in Gun-Owning Households with Children: Results of a 2015 
National Survey. J Urban Health, 2018. 95(3): p. 295-304. 
10. 
Senturia, Y.D., K.K. Christoffel, and M. Donovan, Gun storage patterns in US homes with children. 
A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med, 
1996. 150(3): p. 265-9. 
11. 
Barry, W.E., et al., Pediatric firearm injuries in Los Angeles County: Younger children are more 
likely to be the victims of unintentional firearm injury. J Pediatr Surg, 2019. 54(2): p. 350-353. 
12. 
Hardy, M.S., Teaching firearm safety to children: failure of a program. J Dev Behav Pediatr, 2002. 
23(2): p. 71-6. 
13. 
Scott, J., D. Azrael, and M. Miller, Firearm Storage in Homes With Children With Self-Harm Risk 
Factors. Pediatrics, 2018. 141(3). 
14. 
Johnson, R.M., et al., Who are the owners of firearms used in adolescent suicides? Suicide Life 
Threat Behav, 2010. 40(6): p. 609-11. 
15. 
Barkin, S.L., et al., Is office-based counseling about media use, timeouts, and firearm storage 
effective? Results from a cluster-randomized, controlled trial. Pediatrics, 2008. 122(1): p. e15-25. 
16. 
Nair, R. and S.A. Kohen, Can a patient-directed video improve inpatient advance care planning? 
A prospective pre-post cohort study. BMJ Qual Saf, 2019. 28(11): p. 887-893. 
17. 
Be SMART. Available from: http://besmartforkids.org/resources/. 
18. 
Runyan, C.W., et al., Hospital Emergency Department Lethal Means Counseling for Suicidal 
Patients. Am J Prev Med, 2018. 54(2): p. 259-265. 
19. 
Betz, M.E., et al., Frequency of lethal means assessment among emergency department patients 
with a positive suicide risk screen. Psychiatry Res, 2018. 260: p. 30-35. 

 
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