Trial Outcomes & Findings for Safety Education in the Emergency Department: A Pilot Study (NCT NCT05168878)
NCT ID: NCT05168878
Last Updated: 2024-10-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
407 participants
Primary outcome timeframe
At baseline
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
30-second BeSMART video: 30 second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
95
|
62
|
127
|
123
|
|
Overall Study
COMPLETED
|
51
|
23
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
44
|
39
|
82
|
77
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Education in the Emergency Department: A Pilot Study
Baseline characteristics by cohort
| Measure |
Patient > 9 yo, no Video
n=95 Participants
Caregivers of patients greater than or equal to 10 years old will not be shown a video in the PED.
|
Patient > 9 yo, 3-minute Video
n=62 Participants
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
n=127 Participants
Caregivers of patients of any age will be shown a 30-second BeSMART video in the PED.
30-second BeSMART video: 30-second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3-minute Video
n=123 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age · <24
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Age, Customized
Age · 25-34
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
111 Participants
n=31 Participants
|
|
Age, Customized
Age · 35-44
|
47 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
184 Participants
n=31 Participants
|
|
Age, Customized
Age · 45-54
|
36 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
81 Participants
n=31 Participants
|
|
Age, Customized
Age · >55
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
77 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
339 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
18 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
106 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
274 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: At baselinePopulation: All basline participants
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.
Outcome measures
| Measure |
Patient > 9 yo, 3 Minute Video
n=62 Participants
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
n=127 Participants
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
30-second BeSMART video: 30 second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
n=123 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
|---|---|---|---|---|
|
Acceptability of Intervention
Overall liked the video (agree/ strongly agree)
|
49 Participants
|
104 Participants
|
109 Participants
|
—
|
|
Acceptability of Intervention
Overall liked the video (Neutral/ disagree/ strongly disagree)
|
13 Participants
|
23 Participants
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: Through study completion, an average of three monthsFeasibility 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.
Outcome measures
| Measure |
Patient > 9 yo, 3 Minute Video
n=95 Participants
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
n=62 Participants
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
30-second BeSMART video: 30 second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
n=127 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
n=123 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
|---|---|---|---|---|
|
Feasibility of Follow up
Followed up at three months
|
51 Participants
|
23 Participants
|
45 Participants
|
46 Participants
|
|
Feasibility of Follow up
Did not follow up at three months
|
44 Participants
|
39 Participants
|
82 Participants
|
77 Participants
|
PRIMARY outcome
Timeframe: At baselinePopulation: Any guns kept unlocked at baseline. Only recorded for patient\>9 years old as these patients were all firearm owners whereas "all ages" group had both firearm owners and non-firearm owners.
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.
Outcome measures
| Measure |
Patient > 9 yo, 3 Minute Video
n=95 Participants
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
n=62 Participants
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
30-second BeSMART video: 30 second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
|---|---|---|---|---|
|
Safe Firearm Storage
Are any of the guns in your home kept unlocked? - yes at baseline
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Safe Firearm Storage
Are any of the guns in your home kept unlocked? - no at baseline
|
86 Participants
|
57 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Three month follow upPopulation: Any guns kept unlocked at follow up. Only analyzed for arms of study where all caregivers are firearm owners.
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.
Outcome measures
| Measure |
Patient > 9 yo, 3 Minute Video
n=47 Participants
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
n=18 Participants
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
30-second BeSMART video: 30 second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
|---|---|---|---|---|
|
Safe Firearm Storage at Three Months
Are any of the guns in your home kept unlocked? - yes at follow-up
|
7 Participants
|
0 Participants
|
—
|
—
|
|
Safe Firearm Storage at Three Months
Are any of the guns in your home kept unlocked? - no at follow-up
|
40 Participants
|
18 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At baselinePopulation: Knowledge of temporary 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.
Outcome measures
| Measure |
Patient > 9 yo, 3 Minute Video
n=95 Participants
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
n=62 Participants
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
30-second BeSMART video: 30 second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
n=127 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
n=123 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
|---|---|---|---|---|
|
Knowledge About Temporary Firearm Transfer at Baseline
Knowledge of temporary transfer at baseline - Yes
|
69 Participants
|
47 Participants
|
28 Participants
|
33 Participants
|
|
Knowledge About Temporary Firearm Transfer at Baseline
Knowledge of temporary transfer at baseline - No
|
26 Participants
|
15 Participants
|
99 Participants
|
90 Participants
|
PRIMARY outcome
Timeframe: At study follow-up, an average of three monthsPopulation: Number of participants who answered the question and reported knowledge of temporary transfer of firearms out of the home at 3 month 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.
Outcome measures
| Measure |
Patient > 9 yo, 3 Minute Video
n=49 Participants
Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 30-second Video
n=19 Participants
Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED.
30-second BeSMART video: 30 second video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
n=13 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
Any Age, 3 Minute Video
n=16 Participants
Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED.
3-minute BeSMART video: 3-minute video focused on education about child gun deaths and responsible gun storage
|
|---|---|---|---|---|
|
Knowledge About Temporary Firearm Transfer at Follow up
|
44 Participants
|
18 Participants
|
13 Participants
|
14 Participants
|
Adverse Events
Patient > 9 yo, no Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient > 9 yo, 3 Minute Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Any Age, 30-second Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Any Age, 3 Minute Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place