Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485141
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-10
Brief Title:
BeSMART Secure Storage Counseling in the Inpatient Setting
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
BeSMART Secure Storage Counseling in the Inpatient Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BeSMART
Brief Summary:
Firearm injuries are the leading cause of death for American youth While most of these deaths are homicides approximately one third are suicides and 5 are unintentional shootings where a child gains access to an unsecured firearm and unintentionally pulls the trigger injuring or killing themselves or someone else Secure firearm storage in the home has been shown to significantly reduce the risk of both unintentional shootings and intentional self-harm behavior Additionally approximately 75 of the guns that show up on school grounds come from the homes of youth or their family members or friends Despite evidence that secure storage counseling delivered in the pediatric outpatient setting significantly improves secure storage behavior AND recommendations from the American Academy of Pediatrics to provide secure storage counseling during well child checks rates of counseling continue to be low The Be SMART program is aligned with the American Academy of Pediatrics policy statement and recommendations and provides a scalable solution to efficient counseling in the clinical setting However except for one single site inpatient study the efficacy of the Be SMART program has not been formally evaluated in the inpatient pediatric setting
By rigorously evaluating the efficacy of specific secure storage interventions like Be SMART the investigators can eventually improve counseling frequency with the goal of increasing gun safety behaviors and reducing firearm injuries and deaths in youth
The investigators hypothesize the Be SMART educational intervention when delivered in the pediatric inpatient setting will lead to significant improvement in the primary gun safety behavior endpoint and the secondary endpoint among both gun owners and non-gun owners when compared to control group
By rigorously evaluating the efficacy of specific secure storage interventions like Be SMART the investigators can eventually improve counseling frequency with the goal of increasing gun safety behaviors and reducing firearm injuries and deaths in youth
The investigators hypothesize the Be SMART educational intervention when delivered in the pediatric inpatient setting will lead to significant improvement in the primary gun safety behavior endpoint and the secondary endpoint among both gun owners and non-gun owners when compared to control group
Detailed Description:
This is a randomized controlled trial that will utilize computer generated randomization 11 intervention to control group ratio randomized at the individual patient level Randomization will occur after informed consent is obtained before initial survey is administered The Research Assistant will use computer generated randomization
There will be 150 subjects per study arm 300 total The two enrollment sites will each enroll 150 subjects 75 control and 75 intervention with at least 33 being gun owners For every 30 subjects enrolled the site Principal Investigator and Research Assistant will ensure that 10 are gun owners Once 20 non-owners are enrolled non-gun owner enrollment will be paused until 10 gun owners are enrolled This will ensure distribution of gun-owner enrollment over the entire study recruitment period Enrollment will be ongoing until sample size is reached Control group will receive an education intervention video and handout about the importance of securely storing medications in the home to prevent unintentional ingestions and suicide attempts This is a multisite trial conducted at Monroe Carell Jr Childrens Hospital and Childrens Hospital of Colorado
During the initial study visit after screening enrollment including informed consent randomization and baseline survey the participant will either receive the Be SMART intervention video shown on tablet with Be SMART postcard sized handout OR the control intervention SAFE KIDS medication storage video shown on tablet Immediate post-intervention survey will be completed electronically and the study visit will conclude
The study intervention is the viewing of a brief educational video about the importance of secure firearm storage from the Be SMART program Additionally a secure storage device cable gun lock will be offered to families in the intervention group A clinician will be available to answer any follow-up questions that study participants may have regarding secure firearm storage
The control participants will view a brief medication storage safety video produced by SAFE KIDS A clinician will be available to answer any follow-up questions that study participants may have regarding secure firearm storage This control video was selected because like secure firearm storage it addresses youth injury risk mitigation and self-harm behavior prevention in the home
There are two follow-up visits electronicphone no in-person follow-up required 1-month post-enrollmentintervention delivery and 3 months post-enrollmentintervention delivery Participants will be contacted via their provided e-mail with a link to the follow-up survey There will be 3 attempts to contact participants by email If no response participants will be contacted by phone with 3 attempts If the participants are unable to be reached at this point they will be considered lost to follow-up
There will be 150 subjects per study arm 300 total The two enrollment sites will each enroll 150 subjects 75 control and 75 intervention with at least 33 being gun owners For every 30 subjects enrolled the site Principal Investigator and Research Assistant will ensure that 10 are gun owners Once 20 non-owners are enrolled non-gun owner enrollment will be paused until 10 gun owners are enrolled This will ensure distribution of gun-owner enrollment over the entire study recruitment period Enrollment will be ongoing until sample size is reached Control group will receive an education intervention video and handout about the importance of securely storing medications in the home to prevent unintentional ingestions and suicide attempts This is a multisite trial conducted at Monroe Carell Jr Childrens Hospital and Childrens Hospital of Colorado
During the initial study visit after screening enrollment including informed consent randomization and baseline survey the participant will either receive the Be SMART intervention video shown on tablet with Be SMART postcard sized handout OR the control intervention SAFE KIDS medication storage video shown on tablet Immediate post-intervention survey will be completed electronically and the study visit will conclude
The study intervention is the viewing of a brief educational video about the importance of secure firearm storage from the Be SMART program Additionally a secure storage device cable gun lock will be offered to families in the intervention group A clinician will be available to answer any follow-up questions that study participants may have regarding secure firearm storage
The control participants will view a brief medication storage safety video produced by SAFE KIDS A clinician will be available to answer any follow-up questions that study participants may have regarding secure firearm storage This control video was selected because like secure firearm storage it addresses youth injury risk mitigation and self-harm behavior prevention in the home
There are two follow-up visits electronicphone no in-person follow-up required 1-month post-enrollmentintervention delivery and 3 months post-enrollmentintervention delivery Participants will be contacted via their provided e-mail with a link to the follow-up survey There will be 3 attempts to contact participants by email If no response participants will be contacted by phone with 3 attempts If the participants are unable to be reached at this point they will be considered lost to follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None