Trial Outcomes & Findings for Distribution and Randomization of Gun Safety Devices to Measure Uptake and Preferences (NCT NCT06682403)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

From 2 to 4 weeks

Results posted on

2025-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	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. Received cable lock as default: 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.	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. Choice between cable lock or lock box: Participant will have the option to select a lock box or cable lock shipped to their address after filling out the study survey.
Overall Study STARTED	25	24
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data were not collected as part of the anonymous survey.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Individual Receives Cable Lock as Default n=23 Participants 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. Received cable lock as default: 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.	Individual Has a Choice Between Cable Lock and Lock Box n=22 Participants 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. Choice between cable lock or lock box: Participant will have the option to select a lock box or cable lock shipped to their address after filling out the study survey.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants Age data were not collected as part of the anonymous survey.	0 Participants Age data were not collected as part of the anonymous survey.	0 Participants Age data were not collected as part of the anonymous survey.
Age, Categorical Between 18 and 65 years	0 Participants Age data were not collected as part of the anonymous survey.	0 Participants Age data were not collected as part of the anonymous survey.	0 Participants Age data were not collected as part of the anonymous survey.
Age, Categorical >=65 years	0 Participants Age data were not collected as part of the anonymous survey.	0 Participants Age data were not collected as part of the anonymous survey.	0 Participants Age data were not collected as part of the anonymous survey.
Sex: Female, Male Female	0 Participants Sex (Female, Male) were not collected due to the anonymous nature of the survey.	0 Participants Sex (Female, Male) were not collected due to the anonymous nature of the survey.	0 Participants Sex (Female, Male) were not collected due to the anonymous nature of the survey.
Sex: Female, Male Male	0 Participants Sex (Female, Male) were not collected due to the anonymous nature of the survey.	0 Participants Sex (Female, Male) were not collected due to the anonymous nature of the survey.	0 Participants Sex (Female, Male) were not collected due to the anonymous nature of the survey.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	23 Participants n=23 Participants	22 Participants n=22 Participants	45 Participants n=45 Participants
Visited Pennsylvania Hospital during the study period	23 Participants n=23 Participants	22 Participants n=22 Participants	45 Participants n=45 Participants

PRIMARY outcome

Timeframe: From 2 to 4 weeks

Population: All participants included in the analysis were patients or visitors at Pennsylvania Hospital who self-enrolled via QR code from study signage. Participants were grouped into two arms: those who received only a cable lock and those offered a choice between a cable lock and a lockbox. Survey response rates were analyzed at baseline, 2-week, and 4-week time points.

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.

Outcome measures

Outcome measures
Measure	Baseline n=45 Participants Initial survey administered upon firearm safety device offer or QR scan from brochure/poster.	Follow-up #1 (2-week) n=45 Participants First follow-up survey sent via text two weeks post-enrollment.	Follow-up #2 (4-week) n=45 Participants Second optional follow-up survey at 4 weeks for continued behavior tracking.
Survey Response Rate Respond (No) · Cable Lock Only Group	0 Participants	8 Participants	9 Participants
Survey Response Rate Respond (No) · Choice of Lock Group	0 Participants	9 Participants	12 Participants
Survey Response Rate Respond (Yes) · Cable Lock Only Group	23 Participants	15 Participants	14 Participants
Survey Response Rate Respond (Yes) · Choice of Lock Group	22 Participants	13 Participants	10 Participants

SECONDARY outcome

Timeframe: From 2 to 4 weeks

Population: Participants who completed the follow-up survey and reported having a firearm at home.

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.

Outcome measures

Outcome measures
Measure	Baseline n=15 Participants Initial survey administered upon firearm safety device offer or QR scan from brochure/poster.	Follow-up #1 (2-week) n=13 Participants First follow-up survey sent via text two weeks post-enrollment.	Follow-up #2 (4-week) Second optional follow-up survey at 4 weeks for continued behavior tracking.
Rate of Full Firearm Storage at Follow-Up First Follow-Up	13 Participants	11 Participants	—
Rate of Full Firearm Storage at Follow-Up Second Follow-Up	12 Participants	7 Participants	—

SECONDARY outcome

Timeframe: From 2 to 4 weeks

Population: This analysis includes participants who accepted a cable lock and completed the initial Qualtrics survey by scanning the QR code from the study poster. A total of 45 participants responded to the question regarding their likelihood of using the cable lock within the next week. Responses with missing data for this question (n=5) were counted as "Missing" in the data table.

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.

Outcome measures

Outcome measures
Measure	Baseline n=45 Participants Initial survey administered upon firearm safety device offer or QR scan from brochure/poster.	Follow-up #1 (2-week) First follow-up survey sent via text two weeks post-enrollment.	Follow-up #2 (4-week) Second optional follow-up survey at 4 weeks for continued behavior tracking.
Likelihood of Using Cable Lock Within the Next Week (Extremely Unlikely to Extremely Likely Scale). Somewhat unlikely	0 Participants	—	—
Likelihood of Using Cable Lock Within the Next Week (Extremely Unlikely to Extremely Likely Scale). Very likely	37 Participants	—	—
Likelihood of Using Cable Lock Within the Next Week (Extremely Unlikely to Extremely Likely Scale). Somewhat likely	2 Participants	—	—
Likelihood of Using Cable Lock Within the Next Week (Extremely Unlikely to Extremely Likely Scale). Neither likely nor unlikely	1 Participants	—	—
Likelihood of Using Cable Lock Within the Next Week (Extremely Unlikely to Extremely Likely Scale). Very unlikely	0 Participants	—	—
Likelihood of Using Cable Lock Within the Next Week (Extremely Unlikely to Extremely Likely Scale). Missing	5 Participants	—	—

Adverse Events

Individual Receives Cable Lock as Default

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Individual Has a Choice Between Cable Lock and Lock Box

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mucio Kit Delgado

University of Pennsylvania

Phone: 2157468256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place