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

NCT07501247 | Not Yet Recruiting DMC

• 2 other identifiers: 8571201R01NR021259
• Study Type: interventional
• Target: 7,200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Firearm Injury; Firearm Safety; Suicide

Keywords

Firearm safety; Nurse-led intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Behavioral intention to increase secure firearm storage

  24-72 hour post-discharge

• Behavioral intention to ask about firearms where child stays/visits

  24-72 hour post-discharge

• Permanent or temporary removal of firearms

  2-4 week post-discharge

• Use of cable locks

  2-4 week post-discharge

• Purchase of additional safety devices

  2-4 week post-discharge

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care: routine clinical care plus free cable locks available in the hospital safety center

Adapted S.A.F.E. Firearm and implementation bundle

EXPERIMENTAL

Behavioral: Adapted S.A.F.E. Firearm; Behavioral: Implementation bundle

Behavioral: Adapted S.A.F.E. Firearm; Behavioral: Implementation bundle

Interventions

Adapted S.A.F.E. Firearm BEHAVIORAL

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

Adapted S.A.F.E. Firearm and implementation bundle

Implementation bundle BEHAVIORAL

Electronic health record-based reminder, education, champions

Adapted S.A.F.E. Firearm and implementation bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nurses who work on a nursing unit randomized to the intervention arm

You may not qualify if:

• Not a nurse who works on a nursing unit randomized to the intervention arm
• 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
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Nursing Research (NINR): collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

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

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Katelin Hoskins, PhD

CONTACT

215-573-3051; hoskinsk@upenn.edu

Chelsea Ward McIntosh, MS

CONTACT

215-590-1244; wardc8@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst will be blinded to randomization assignment
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel arm cluster randomized control trial

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (2)