Clinical trial NCT06682403: Distribution and Randomization of Gun Safety Devices to Measure Uptake and Preferences
Official title: Hospital Security Program for Engaging Communities With Firearm Safe Storage Devices and Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gun Violence Prevention
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who fill out the survey linked to study posters and brochures will be randomized to either receive a cable lock as the default safety device option or the choice between a cable lock or lock box, shipped to their address. For individuals who take a cable lock at time of receiving a brochure, they are automatically assigned into the cable lock group.
Primary purpose: PREVENTION

Brief summary: This study aims to enhance workplace safety by implementing a firearm safety program at Penn Medicine\&amp;amp;amp;amp;#39;s Pennsylvania Hospital (PAH). The option to store firearms securely during visits is offered to firearm owners. The study focuses on understanding barriers and facilitators to this program and piloting methods to collect data on firearm storage device use. The approach prioritizes participant confidentiality and pragmatism. The study design involves iterative pilot testing of data collection methods and comparison of acceptance and usage rates between cable locks and lock boxes through randomization. The intended outcome is to provide evidence supporting the scalability and effectiveness of the program. The study population includes patients and visitors who accept firearm safety materials or express interest in receiving a firearm storage device. The primary outcome measure is survey response rate, with secondary outcomes including firearm storage behavior and likelihood of using a gun safety device. Additionally, the study explores variations in survey distribution methods.

Detailed description: To prevent workplace violence, in November 2021, Penn Medicine implemented the Evolv weapons detection system in Pennsylvania Hospital (PAH) (1,2). For individuals who self-disclose they are carrying a weapon, or who are identified with weapon during screening, security guards offer the individual the option to leave with weapon, or to place it in a safe, at the hospital, for storage. Security guards return the weapon when the patient or visitor is ready to leave. Beginning in July 2022 team piloted a program in which security guards offer a cable lock and safety brochure when the gun owner returns to retrieve firearm at the conclusion of visit. To date, 47% of patients and visitors who stored a firearm with security have taken a cable lock when offered, resulting in over 400 firearm safety locks and brochures distributed to firearm owners. The Aims of this study are to: (1) Elucidate barriers and facilitators to implementing a hospital security screening firearm safety program through interviews with hospital security staff; (2) Design and pilot test a method for collecting data on storage device use among patients and visitors who accept firearm safety materials; (3) Conduct a pilot of distributing lockboxes and compare acceptance and usage rates to cable locks.

This protocol is for Aim 2 and 3 of the study. The rationale for this aim is that traditional research methods for collecting data on firearm safe storage have not been optimized for use in a pragmatic setting to ensure acceptability and confidentiality. Priority in firearm safety education and device distribution is to get the necessary information and supplies to those in need or desire such resources. To achieve this, any data collection must be done in a low profile, confidential, and non-threatening way. This is particularly important not only because discussions of firearm ownership can be politically charged, but also because some community members may not be legally licensed to own or carry a firearm, and some may even be legally prohibited from doing so. The legal status of gun ownership does not lessen the need for safety information and support-indeed, unlicensed firearm owners may have even fewer safety resources available for the. Priority is therefore to reach as many individuals as possible while subjecting participants to as little scrutiny as possible. Therefore, the aim is to design a data collection approach that will prioritize preserving participant confidentiality. Approach will be iterative pilot tests of data collection methods including embedding unique quick response (QR) codes linked to surveys in firearm safety brochures and study poster signage. The opportunity will be offered for individuals to take home a cable lock after visiting or to scan the QR code on the brochure/poster to fill out the study survey and get a safety device shipped to a participant address. Participants who fill out the study survey will be randomized to receive either a cable lock as the default or a choice between cable lock and lock box to test acceptance and usage rates. For those who accepted a cable lock at the hospital will automatically be grouped in the cable lock default group. The hypothesis that is being tested is if iterative pilot testing will reveal a feasible method that balances pragmatism and confidentiality as well as compare acceptance and usage rates among cable locks and lock boxes.

The intended outcome of this study is development of critical evidence to facilitate the scaling of this program to other hospitals and launch a promising research program to study the acceptability, long term use, and cost-effectiveness of a scalable approach to promote safe firearm storage.

This research study is to design and pilot test a method for collecting data on storage device use among patients and visitors who accept firearm safety materials or are interested in receiving a firearm storage device shipped to the participant\&#39;s address. The study design is an iterative pilot test of survey data collection methods and determination of scalability and feasibility for distribution of firearm storage devices. The study population and sample will be (a) individuals who are patients or visitors to PAH who are screened for a firearm, screen positive, and accept a firearm safety brochure and storage device OR (b) individuals interested in receiving a firearm storage device and self-scan the unique QR code on the study poster in the entry hall of PAH with minimal or no security supervisor engagement. A unique QR code linking directly to the initial survey will be embedded into the firearm safety brochure as well as the poster in the entry hall of PAH next to the distribution area. Individual group (a) will be informed by security that survey participation is optional, but that it is helpful for efforts. Individual group (b) will not be actively engaged by security, and will self-enroll in the study by viewing the posted signage and completing the QR code linked survey.

Eligibility criteria: Inclusion Criteria:

1. Individuals who are visitors or patients at Penn Medicine Facilitates who are identified through security screening as carrying a firearm, and who accept a firearm safety brochure and scan the QR code in the brochure; OR
2. Any patient or visitor interested in receiving a firearm storage device who self-selects into the study by scanning the QR code on the study poster; OR
3. Any individual interested in receiving a firearm storage device who clicks the link to the survey posted on the Penn Medicine Safety Measures website that is included health system appointment reminders.

Exclusion Criteria:

* Individuals who have already completed the survey or have already requested a gun safety device.

Primary outcomes:
measure: Survey response rate
timeFrame: 24 hours
Secondary outcomes:
measure: Firearm storage behavior
timeFrame: 2 weeks, 4 weeks
measure: Likelihood of using the gun safety device
timeFrame: 2 weeks, 4 weeks
Other outcomes:
measure: Survey pathways for engagement
timeFrame: 2 weeks, 4 weeks
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mucio K Delgado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Elinore Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Katelin Hoskins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham RM, Walton MA, Carter PM. The Major Causes of Death in Children and Adolescents in the United States. N Engl J Med. 2018 Dec 20;379(25):2468-2475. doi: 10.1056/NEJMsr1804754. No abstract available.