Trial of a Nurse-Led Firearm Safety Intervention in the Pediatric Inpatient Setting

Hybrid Effectiveness-Implementation Trial of a Nurse-Led Firearm Safety Intervention in the Pediatric Inpatient Setting

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicide; Firearm Injury; Firearm Safety
• Intervention / Treatment: Behavioral: Adapted S.A.F.E. Firearm; Behavioral: Implementation bundle

Detailed Description

The proposed study aims to reduce firearm-related deaths in children by scaling out an evidence-based secure firearm storage program. S.A.F.E. Firearm is an evidence-based program that includes (1) brief, parent-directed discussion on secure firearm storage using a harm reduction approach and (2) free cable locks offers to all parents during well child visits in pediatric primary care. Importantly, S.A.F.E. Firearm has potential to save lives beyond primary care, and pediatric inpatient settings are an advantageous context for S.A.F.E. Firearm implementation. Across the U.S. there are over 250 children's hospitals, approximately two million children are hospitalized yearly, and parental engagement is a core feature of care. Children's Hospital of Philadelphia (CHOP) is a large, nonprofit pediatric health care system with two freestanding children's hospitals in the greater Philadelphia region. As part of Aim 1 of this project, the research team is adapting S.A.F.E. Firearm for the pediatric inpatient setting and nurse-led delivery, plus developing a bundle of implementation strategies. The research team anticipates including an electronic health record-based reminder, education, and champions as part of the bundle.

In the present study, the research team will conduct a pragmatic parallel cluster randomized hybrid type II effectiveness-implementation trial across two CHOP hospitals. Inpatient nursing unit clusters will be randomized to receive adapted S.A.F.E. Firearm or usual care, defined as routine clinical care plus free cable locks available in the hospital safety center. Implementation outcomes will be examined through mixed methods.

Aims for the study include:

Aim 2. Conduct a pragmatic parallel cluster randomized hybrid type II effectiveness-implementation trial with inpatient nursing units at CHOP to test whether parents exposed to adapted S.A.F.E. Firearm report greater improvements in secure storage (primary outcome) compared to parents exposed to usual care over one year of active implementation. Secondary outcomes are additional firearm safety behaviors (e.g., firearm removal).

Aim 3. Examine the effect of the implementation strategy bundle on S.A.F.E. Firearm implementation outcomes. The research team will evaluate the proximal impacts of the implementation strategy bundle. The primary implementation outcome is reach (i.e., electronic health record-documented program delivery). Secondary outcomes include fidelity, acceptability, and maintenance. The research team will also explore implementation strategy processes and mechanisms via qualitative interviews with nurses.

• Study Type: Interventional
• Enrollment (Estimated): 7200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katelin Hoskins, PhD; Phone Number: 215-573-3051; Email: hoskinsk@upenn.edu
• Study Contact Backup: Name: Chelsea Ward McIntosh, MS; Phone Number: 215-590-1244; Email: wardc8@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
      • Contact: Chelsea Ward McIntosh, MS; Phone Number: 215-590-1244; Email: wardc8@chop.edu
      • Contact: Joel Fein, MD; Phone Number: 610-308-3874; Email: fein@chop.edu
      • Principal Investigator: Joel Fein, MD
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
      • Contact: Katelin Hoskins, PhD; Phone Number: 215-919-0281; Email: hoskinsk@upenn.edu
      • Principal Investigator: Katelin Hoskins, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care: routine clinical care plus free cable locks available in the hospital safety center
Experimental: Adapted S.A.F.E. Firearm and implementation bundle; Behavioral: Adapted S.A.F.E. Firearm; Behavioral: Implementation bundle	Behavioral: Adapted S.A.F.E. Firearm; S.A.F.E. Firearm is an evidence-based program that includes (1) brief, parent-directed discussion on secure firearm storage using a harm reduction approach and (2) free cable locks offers to all parents; Behavioral: Implementation bundle; Electronic health record-based reminder, education, champions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secure Storage	Count of participants with secure storage, which is defined as parent self-reported locked firearm storage. Locked storage reflects stored in a locked gun safe, cabinet, case, gun rack, and/or storage with a cable or trigger lock. Categories: none, some, all locked, don't know, prefer not to answer.	2-4 week post-discharge, collected over 1 year of active implementation
Reach	Percentage reached, i.e., the percentage of eligible visits with electronic health record-documented receipt of both intervention components (intervention arm only).	Documented in EHR at point of intervention delivery over 1 year of active implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral intention to increase secure firearm storage	Count of participants with self-reported intention (i.e., motivation) to make firearms stored in or around their home less accessible to their child. Categories: strongly agree, agree, neither, disagree, strongly disagree, not applicable, prefer not to answer.	24-72 hour post-discharge
Behavioral intention to ask about firearms where child stays/visits	Count of participants with self-reported intention (i.e., motivation) to ask about firearms and how they are stored in places where their child stays/visits. Categories: strongly agree, agree, neither, disagree, strongly disagree, not applicable, prefer not to answer.	24-72 hour post-discharge
Permanent or temporary removal of firearms	Percentage of participants with self-reported permanent or temporary removal of firearms from the household. Categories: Any removal, no removal.	2-4 week post-discharge
Use of cable locks	Count of participants with self-reported use of distributed cable locks. Categories: Used it to secure a firearm in my home, used it to lock something other than a firearm, put it away for potential future use, gave the lock to someone else to secure a firearm, threw away the lock, not sure, prefer not to answer.	2-4 week post-discharge
Purchase of additional safety devices	Percentage of participants with self-reported purchase of additional firearm safety devices. Categories: yes, no, prefer not to answer.	2-4 week post-discharge
Load status	Count of participants with self-reported firearm load status. Categories: all, some, none unloaded, don't know, prefer not to answer.	2-4 week post-discharge
Lock and load status combined	Percentage of participants with self-reported firearm storage by both unlocked and loaded status. Categories: yes, no, don't know, prefer not to answer.	2-4 week post-discharge
Ammunition status	Percentage of participant-self reported separate storage of all ammunition. Categories: yes, no, don't know, prefer not to answer.	2-4 week post-discharge
Inquiry about firearms where child stays/visits	Count of participants with self-reported inquiry about firearms where their child stays/visits since discharge. Categories: more than once, once, never, not applicable, prefer not to answer.	2-4 week post-discharge
Secure storage (3 months)	Count of participants with secure storage, which is defined as parent self-reported locked firearm storage. Locked storage reflects stored in a locked gun safe, cabinet, case, gun rack, and/or storage with a cable or trigger lock. Categories: none, some, all locked, don't know, prefer not to answer.	3 month post-discharge
Permanent or temporary removal of firearms (3 months)	Percentage of participants with self-reported permanent or temporary removal of firearms from the household. Categories: Any removal, no removal.	3 month post-discharge
Use of cable locks (3 months)	Count of participants with self-reported use of distributed cable locks. Categories: Used it to secure a firearm in my home, used it to lock something other than a firearm, put it away for potential future use, gave the lock to someone else to secure a firearm, threw away the lock, not sure, prefer not to answer.	3 month post-discharge
Purchase of additional safety devices (3 month)	Percentage of participants with self-reported purchase of additional firearm safety devices. Categories: yes, no, prefer not to answer.	3 month post-discharge
Load status (3 months)	Count of participants with self-reported firearm load status. Categories: all, some, none unloaded, don't know, prefer not to answer.	3 month post-discharge
Lock and load status combined (3 months)	Percentage of participants with self-reported firearm storage by both unlocked and loaded status. Categories: yes, no, don't know, prefer not to answer.	3 month post-discharge
Ammunition status (3 months)	Percentage of participants with self-reported separate storage of all ammunition. Categories: yes, no, don't know, prefer not to answer.	3 month post-discharge
Inquiry about firearms where child stays/visits (3 months)	Count of participants with self-reported inquiry about firearms where their child stays/visits in past 2 months. Categories: more than once, once, never, not applicable, prefer not to answer.	3 month post-discharge
Fidelity	Percentage of participants with self-reported receipt of both intervention components (intervention arm only).	24-72 hour post-discharge
Acceptability	Percentage of participants with self-reported acceptability of adapted S.A.F.E. Firearm (intervention arm only).	24-72 hour post-discharge
Maintenance	Percentage reached (i.e., percentage of eligible visits with electronic health record-documented receipt of both intervention components) over 6 months of post-active implementation (intervention arm only).	Documented in EHR at point of intervention delivery over 6 months of maintenance

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Children's Hospital of Philadelphia; National Institute of Nursing Research (NINR)

Publications and helpful links

Helpful Links

• Study information on the CHOP Center for Violence Prevention's website

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nurse-led intervention; Firearm safety
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide
• Other Study ID Numbers: 857120; 1R01NR021259 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No