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Firearm Secure Storage Device Distribution RCT

2026年11月2日 更新者:University of Pennsylvania

Comparative Effectiveness of Firearm Secure Storage Device Distribution Strategies: A Hybrid Type 1 Effectiveness-Implementation Randomized Clinical Trial

This study aims to learn how to best promote safe firearm storage in the community. Firearm injuries are a major public health concern, and securely storing firearms can help prevent accidental injuries, suicide, and unauthorized access. This research will test whether providing people with a choice of firearm storage devices improves safe storage practices compared to providing standard cable locks alone. Adults who are patients, visitors, or employees at participating Penn Medicine community health centers may choose to enroll by scanning a QR code displayed at the site. After reviewing study information and providing consent, participants will complete a short online survey about firearm ownership and storage practices. Participants will then be randomly assigned to receive either cable locks or a choice of storage devices such as a lock box and/or cable locks, which will be mailed to their home at no cost. Participants will receive firearm safety educational materials and will be asked to complete brief follow-up surveys by text message about one month and three months later. Some participants and health center staff may also be invited to participate in interviews about their experiences with the program. The goal of this research is to identify practical and acceptable ways for health systems to support safe firearm storage and reduce firearm-related injuries in diverse communities.

研究概览

研究类型

介入性

注册 (估计的)

1858

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • Penn Medicine
        • 接触:
        • 接触:
        • 首席研究员:
          • Mucio (Kit) Delgado, MD, MS
        • 首席研究员:
          • Elinore Kaufman, MD, MSHP, FACS
        • 副研究员:
          • Katelin Hoskins, PhD, MBE
        • 副研究员:
          • Renee Betancourt, MD
        • 副研究员:
          • Michael Harhay, PhD, MPH

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient, visitor, or employee at enrollment site
  • Can access QR code survey at enrollment site via smartphone and have access to text messaging
  • Have a residential [U.S.] mailing address
  • Report a firearm at home
  • Request a secure storage device

Exclusion Criteria:

  • Prior enrollment from same household address (needed to preserve independence of study observations)
  • Inability to complete study consent and assessments in English or Spanish

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Cable lock distribution (usual practice)

Up to 5 cable locks

Participants assigned to this intervention will receive up to five firearm cable locks at no cost. The cable locks will be mailed to the participant's home along with firearm safety educational materials.

有源比较器:Choice of a lock box and/or cable locks (choice of preferred devices)

Preferred device option, with choices of: (A) up to 5 cable locks; (B) lock box only; or (C) lock box plus up to 4 cable locks

Participants assigned to this intervention will receive up to five firearm cable locks at no cost. The cable locks will be mailed to the participant's home along with firearm safety educational materials.

Participants assigned to this intervention will receive one firearm lock box at no cost. The lock box will be mailed to the participant's home along with firearm safety educational materials.

Participants assigned to this intervention will receive one firearm lock box and up to four firearm cable locks at no cost. The storage devices will be mailed to the participant's home along with firearm safety educational materials.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of Participants Reporting All Firearms Stored Securely at 30 Days
大体时间:30 days after enrollment

Proportion of participants reporting that all firearms in or around their home are stored securely (vs. some or none) on the 30-day follow-up survey. Secure storage will be assessed through participant self-report using the following response options: Yes, all of them (1); Yes, some of them (2); None of them (3); Not sure (4); No guns in or around home (5); and Prefer not to answer (6).

30 days after enrollment

次要结果测量

结果测量
措施说明
大体时间
Proportion of participants with all firearms stored securely at 3 months
大体时间:3 months after enrollment

Proportion of participants reporting that all firearms in the household are stored securely (vs. some or none) on the 3-month follow-up survey.

3 months after enrollment
Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 1 month
大体时间:30 days after enrollment

Participants reporting that some household firearms are stored securely (vs. none) on 1 month follow-up survey after device distribution.

30 days after enrollment
Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 3 months
大体时间:3 months after enrollment

Participants reporting that some household firearms are stored securely (vs. none) on 3 month follow-up survey after device distribution.

3 months after enrollment
Number of preferred firearm storage devices requested
大体时间:Baseline (enrollment)

Among patients randomized to the preferred device arm, the number of firearm storage devices requested by participants will be assessed.

Baseline (enrollment)
Incremental intervention cost per participant
大体时间:Baseline (enrollment)

Incremental cost of delivering the intervention, including the cost of firearm storage devices and associated shipping costs. Costs will be calculated in US dollar per participant

Baseline (enrollment)

其他结果措施

结果测量
措施说明
大体时间
Number of Participants by Cable Lock Frequency at 30 Days
大体时间:30 days after enrollment

Frequency of cable lock use among participants reporting use of cable locks on firearms at the 30-day follow-up assessment. Participants will report how often cable locks are used using the following response options:

  • Always (1)
  • More than half the time (2)
  • Less than half the time (3)
30 days after enrollment
Number of Participants by Cable Lock Frequency at 90 Days
大体时间:90 days after enrollment

Frequency of cable lock use among participants reporting use of cable locks on firearms at the 90-day follow-up assessment. Participants will report how often cable locks are used using the following response options:

  • Always (1)
  • More than half the time (2)
  • Less than half the time (3)
90 days after enrollment
Number of Participants by Cable Lock Frequency at 180 Days
大体时间:180 days after enrollment

Frequency of cable lock use among participants reporting use of cable locks on firearms at the 180-day follow-up assessment. Participants will report how often cable locks are used using the following response options:

  • Always (1)
  • More than half the time (2)
  • Less than half the time (3)
180 days after enrollment
Number of Cable Locks by Recipient Type at 30 Days
大体时间:30 days after enrollment

Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 30-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.

30 days after enrollment
Number of Cable Locks by Recipient Type at 90 Days
大体时间:90 days after enrollment

Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 90-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.

90 days after enrollment
Number of Cable Locks by Recipient Type at 180 Days
大体时间:180 days after enrollment

Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 180-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.

180 days after enrollment
Number of Participants by Lock Box Usage Category at 30 Days
大体时间:30 days after enrollment

Lock box usage will be assessed through participant self-report at the 30-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.

30 days after enrollment
Number of Participants by Lock Box Usage Category at 90 Days
大体时间:90 days after enrollment

Lock box usage will be assessed through participant self-report at the 90-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.

90 days after enrollment
Number of Participants by Lock Box Usage Category at 180 Days
大体时间:180 days after enrollment

Lock box usage will be assessed through participant self-report at the 180-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.

180 days after enrollment
Number of Participants by Lock Box Recipient Type at 30 Days
大体时间:30 days after enrollment

Lock box possession will be assessed through participant self-report at the 30-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.

30 days after enrollment
Number of Participants by Lock Box Recipient Type at 90 Days
大体时间:90 days after enrollment

Lock box possession will be assessed through participant self-report at the 90-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.

90 days after enrollment
Number of Participants by Lock Box Recipient Type at 180 Days
大体时间:180 days after enrollment

Lock box possession will be assessed through participant self-report at the 180-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.

180 days after enrollment
Number of Participants by Lock Box Frequency at 30 Days
大体时间:30 days after enrollment

Frequency of lock box use will be assessed through participant self-report at the 30-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.

30 days after enrollment
Number of Participants by Lock Box Frequency at 90 Days
大体时间:90 days after enrollment

Frequency of lock box use will be assessed through participant self-report at the 90-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.

90 days after enrollment
Number of Participants by Lock Box Frequency at 180 Days
大体时间:180 days after enrollment

Frequency of lock box use will be assessed through participant self-report at the 180-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.

180 days after enrollment
Number of Participants by Cable Lock Usage Category at 30 Days
大体时间:30 days after enrollment

Cable lock usage will be assessed through participant self-report at the 30-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.

30 days after enrollment
Number of Participants by Cable Lock Usage Category at 90 Days
大体时间:90 days after enrollment

Cable lock usage will be assessed through participant self-report at the 90-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.

90 days after enrollment
Number of Participants by Cable Lock Usage Category at 180 Days
大体时间:180 days after enrollment

Cable lock usage will be assessed through participant self-report at the 180-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.

180 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 30 days
大体时间:30 days after enrollment

Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.

30 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 90 days
大体时间:90 days after enrollment

Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.

90 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 180 days
大体时间:180 days after enrollment

Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.

180 days after enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mucio (Kit) Delgado, MD, MS、University of Pennsylvania
  • 首席研究员:Elinore Kaufman, MD, MSHP、University of Pennsylvania

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月21日

初级完成 (估计的)

2029年10月1日

研究完成 (估计的)

2030年9月1日

研究注册日期

首次提交

2026年10月1日

首先提交符合 QC 标准的

2026年10月19日

首次发布 (实际的)

2026年10月21日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 26-6055

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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