Clinical trial NCT06485141: BeSMART Secure Storage Counseling in the Inpatient Setting
Official title: BeSMART Secure Storage Counseling in the Inpatient Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Firearm Injury
Safety Issues
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: This is a randomized controlled trial, that will utilize computer generated randomization, 1:1 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. Children's Hospital and Children's 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 (electronic/phone, no in-person follow-up required): 1-month post-enrollment/intervention delivery and 3 months post-enrollment/intervention 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.

Eligibility criteria: Inclusion Criteria (must meet ALL):

1. Provision of signed and dated informed consent form
2. Caregiver of child hospitalized on a pediatric hospital medicine service aged 0-17
3. English or Spanish speaking caregiver
4. Access to necessary resources for participating in a technology-based intervention follow-up assessments (e-mail and telephone)

Exclusion Criteria:

1. Caregivers of children admitted for firearm injury
2. Caregivers of children with a firearm injury within the last 3 months
3. Caregivers of children admitted with a primary psychiatric diagnosis including suicidal ideation, self-harm, homicidal ideation, aggression, or intentional ingestion
4. Caregivers of children who are admitted to a surgical co-management team

Non-gun owners will be excluded intermittently throughout the enrollment period based on proportion of gun owners enrolled. For every 30 study participants enrolled, 10 must be gun owners. Non-gun owner enrollment will be paused until 10 gun owners are enrolled and this cycle will repeat for every 30 participants enrolled at each study site.

Primary outcomes:
measure: Secure firearm storage among gun owners
timeFrame: 1 month
measure: Asking about firearm storage among all participants
timeFrame: 1 month
Secondary outcomes:
measure: Asking about firearm storage among all participants
timeFrame: 3 months
Other outcomes:
measure: Firearm Storage Knowledge
timeFrame: 1 month and 3 months
measure: Secure firearm storage among gun owners
timeFrame: 3 months
measure: Locking behavior
timeFrame: 1 month and 3 months
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kelsey Gastineau, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: