Trial of a Nurse-Led Firearm Safety Intervention in the Pediatric Inpatient Setting (NCT07501247) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trial of a Nurse-Led Firearm Safety Intervention in the Pediatric Inpatient Setting
United States7,200 participantsStarted 2026-12
Plain-language summary
In this randomized controlled trial, researchers will assess the effectiveness and implementation of S.A.F.E. Firearm in the inpatient pediatric hospital setting. S.A.F.E. Firearm has been adapted for nurse-led delivery to parents/caregivers (hereafter, parents) of hospitalized youth. Adapted S.A.F.E. Firearm involves a brief discussion between nurses and parents about secure firearm storage and an offer of a free firearm cable lock. Researchers will test S.A.F.E. Firearm and a bundle of strategies intended to support the routinization of S.A.F.E. Firearm into nursing workflows.
The questions the study aims to answer are:
* How effective is adapted S.A.F.E. Firearm at changing parents' firearm storage behavior?
* How effective is the implementation strategy bundle at increasing delivery of adapted S.A.F.E. Firearm?
Some parents will be invited to participate in surveys about their experiences with adapted S.A.F.E. Firearm, and some nurses will be invited to participate in interviews about their experiences with the implementation strategy bundle.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Health System Employees):
* Nurses who work on a nursing unit randomized to the intervention arm
Exclusion Criteria (Health System Employees):
* Not a nurse who works on a nursing unit randomized to the intervention arm
Inclusion Criteria (Parents of Hospitalized Youth):
* Parent/guardian of youth ages 0-17 years old hospitalized on a participating inpatient unit (either Intervention or Usual Care arm) during the trial period
* Age greater than or equal to 18 years old
* At least 1 parent/guardian must be at the bedside to receive intervention prior to discharge
Exclusion Criteria (Parents of Hospitalized Youth):
* Not a parent/legal guardian of youth ages 0 through 17-years-old hospitalized on a participating inpatient unit during the trial period
* Identified as clinically inappropriate (e.g., due to medical acuity or imminent transfer) based on judgment of nursing staff
* Primary language other than English, Spanish, Arabic, Mandarin/Chinese, Portuguese, and/or French
* Has completed the trial surveys within the past 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Secure Storage
Timeframe: 2-4 week post-discharge, collected over 1 year of active implementation
2
Reach
Timeframe: Documented in EHR at point of intervention delivery over 1 year of active implementation