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NCT Number: NCT07501247

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.

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Key information

Conditions

Firearm Safety Behavior Behavioral Symptoms Firearm Injury Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Implementation bundle

Behavioral

Electronic health record-based reminder, education, champions

Primary outcomes

  1. Secure Storage

    Time frame: 2-4 week post-discharge, collected over 1 year of active implementation

    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. Reach

    Time frame: Documented in EHR at point of intervention delivery over 1 year of active implementation

    Percentage reached, i.e., the percentage of eligible visits with electronic health record-documented receipt of both intervention components (intervention arm only).

Secondary outcomes

  1. Behavioral intention to increase secure firearm storage

    Time frame: 24-72 hour post-discharge

    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.

  2. Behavioral intention to ask about firearms where child stays/visits

    Time frame: 24-72 hour post-discharge

    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.

  3. Permanent or temporary removal of firearms

    Time frame: 2-4 week post-discharge

    Percentage of participants with self-reported permanent or temporary removal of firearms from the household. Categories: Any removal, no removal.

  4. Use of cable locks

    Time frame: 2-4 week post-discharge

    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.

  5. Purchase of additional safety devices

    Time frame: 2-4 week post-discharge

    Percentage of participants with self-reported purchase of additional firearm safety devices. Categories: yes, no, prefer not to answer.

  6. Load status

    Time frame: 2-4 week post-discharge

    Count of participants with self-reported firearm load status. Categories: all, some, none unloaded, don't know, prefer not to answer.

  7. Lock and load status combined

    Time frame: 2-4 week post-discharge

    Percentage of participants with self-reported firearm storage by both unlocked and loaded status. Categories: yes, no, don't know, prefer not to answer.

  8. Ammunition status

    Time frame: 2-4 week post-discharge

    Percentage of participant-self reported separate storage of all ammunition. Categories: yes, no, don't know, prefer not to answer.

  9. Inquiry about firearms where child stays/visits

    Time frame: 2-4 week post-discharge

    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.

  10. Secure storage (3 months)

    Time frame: 3 month post-discharge

    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.

  11. Permanent or temporary removal of firearms (3 months)

    Time frame: 3 month post-discharge

    Percentage of participants with self-reported permanent or temporary removal of firearms from the household. Categories: Any removal, no removal.

  12. Use of cable locks (3 months)

    Time frame: 3 month post-discharge

    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.

  13. Purchase of additional safety devices (3 month)

    Time frame: 3 month post-discharge

    Percentage of participants with self-reported purchase of additional firearm safety devices. Categories: yes, no, prefer not to answer.

  14. Load status (3 months)

    Time frame: 3 month post-discharge

    Count of participants with self-reported firearm load status. Categories: all, some, none unloaded, don't know, prefer not to answer.

  15. Lock and load status combined (3 months)

    Time frame: 3 month post-discharge

    Percentage of participants with self-reported firearm storage by both unlocked and loaded status. Categories: yes, no, don't know, prefer not to answer.

  16. Ammunition status (3 months)

    Time frame: 3 month post-discharge

    Percentage of participants with self-reported separate storage of all ammunition. Categories: yes, no, don't know, prefer not to answer.

  17. Inquiry about firearms where child stays/visits (3 months)

    Time frame: 3 month post-discharge

    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.

  18. Fidelity

    Time frame: 24-72 hour post-discharge

    Percentage of participants with self-reported receipt of both intervention components (intervention arm only).

  19. Acceptability

    Time frame: 24-72 hour post-discharge

    Percentage of participants with self-reported acceptability of adapted S.A.F.E. Firearm (intervention arm only).

  20. Maintenance

    Time frame: Documented in EHR at point of intervention delivery over 6 months of 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsea Ward McIntosh, MS

CONTACT

[email protected]

215-590-1244

Katelin Hoskins, PhD

CONTACT

[email protected]

215-573-3051

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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