- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06682403
Distribution and Randomization of Gun Safety Devices to Measure Uptake and Preferences
Hospital Security Program for Engaging Communities With Firearm Safe Storage Devices and Interventions
Study Overview
Status
Conditions
Intervention / Treatment
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'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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individual receives cable lock as default
Participants in this arm are either automatically assigned due to taking a cable lock at the hospital when offered AND fill out the survey OR are randomized into this group by filling out the study survey linked in study materials.
|
Participants will receive a cable lock as the default safety device option after filling out the survey.
If the participant took a cable lock during their hospital visit and noted this in the survey, they will not be shipped a cable lock.
If participants did not take a cable lock and noted this in the survey, they will be shipped a cable lock.
|
|
Experimental: Individual has a choice between cable lock and lock box
Participants in this arm are randomized into it based on NOT taking a cable lock at the hospital when offered AND fill out the survey OR are randomized into this group by filling out the study survey linked in study materials.
|
Participant will have the option to select a lock box or cable lock shipped to their address after filling out the study survey.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survey Response Rate
Time Frame: From 2 to 4 weeks
|
The primary outcome measure is survey response rate, defined as whether an eligible visitor or patient completed the firearm storage survey after accepting firearm safety materials or after scanning the QR code on the study poster.
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From 2 to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Full Firearm Storage at Follow-Up
Time Frame: From 2 to 4 weeks
|
The secondary outcome was the rate of full firearm storage, defined as participants who responded "Yes, all of them" on the follow-up survey.
Of the 45 participants who reported having a firearm at home and received the safety devices, 28 completed the first follow-up survey and were included in the primary outcome analysis.
Among the 28 participants who completed the first follow-up, 24 responded to the second follow-up survey.
17 participants did not respond to the first follow-up survey and were therefore excluded from the analysis.
|
From 2 to 4 weeks
|
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Likelihood of Using Cable Lock Within the Next Week (Extremely Unlikely to Extremely Likely Scale).
Time Frame: From 2 to 4 weeks
|
The survey were asked to indicate their likelihood of using the device within the next week.
Responses were collected using a 5-point Likert scale ranging from "Extremely unlikely" to "Extremely likely."
This measure is intended to assess anticipated short-term behavior change related to firearm safe storage following receipt of a safety device.
Responses are collected through an initial Qualtrics web-based survey and analyzed as part of the study's secondary outcomes to evaluate the acceptability and intended use of the distributed firearm safety materials.
|
From 2 to 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mucio K Delgado, MD, University of Pennsylvania
- Principal Investigator: Elinore Kaufman, MD, University of Pennsylvania
- Principal Investigator: Katelin Hoskins, MD, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 855259
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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