BeSMART Secure Storage Counseling in the Inpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Asking about firearm storage among all participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(must meet ALL):
- •Provision of signed and dated informed consent form
- •Caregiver of child hospitalized on a pediatric hospital medicine service aged 0-17
- •English or Spanish speaking caregiver
- •Access to necessary resources for participating in a technology-based intervention follow-up assessments (e-mail and telephone)
排除标准
- •Caregivers of children admitted for firearm injury
- •Caregivers of children with a firearm injury within the last 3 months
- •Caregivers of children admitted with a primary psychiatric diagnosis including suicidal ideation, self-harm, homicidal ideation, aggression, or intentional ingestion
- •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.
研究组 & 干预措施
Control
Guardians of hospitalized children in the active comparator group will view a brief medication storage safety video produced by Safe Kids.
干预措施: Safe Kids Medication (Behavioral)
Intervention
Guardians of hospitalized children will receive the study intervention, viewing a 3 minute educational video about the importance of secure firearm storage from the Be SMART program. Additionally, a cable gun lock will be offered to families in the intervention group along with a Frequently Asked Questions handout from Be SMART.
干预措施: Safe Storage Intervention (Behavioral)
结局指标
主要结局
Asking about firearm storage among all participants
时间窗: 1 month
Self- report based on the survey question "How often do you ask about the presence of firearms in homes where your child(ren) visits?". Response to the survey question is a Likert scale asking frequency (Never-Rarely - Sometimes - Always - Often).
Secure firearm storage among gun owners
时间窗: 1 month
Self-reported secure storage behavior will be the primary endpoint for gun-owners in the sample. Participants will respond to the survey question of "Please share how the majority (meaning more than half) of the guns (such as pistols, revolvers, shotguns, and rifles) in your home/vehicles are stored." with an ordinal scale of storage (Locked and Unloaded, Locked and Loaded, Unlocked and Unloaded, and Unlocked and Loaded) in decreasing order of safety. Responses will be analyzed comparing Locked and Unloaded to the other three choices for a dichotomous measure.
次要结局
- Asking about firearm storage among all participants(3 months)
研究者
Kelsey Gastineau
Assistant Professor of Pediatrics
Vanderbilt University Medical Center