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

April 7, 2026 updated by: University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Principal Investigator:
          • Joel Fein, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Katelin Hoskins, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2-4 week post-discharge, collected over 1 year of active implementation
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).
Documented in EHR at point of intervention delivery over 1 year of active implementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24-72 hour post-discharge
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.
24-72 hour post-discharge
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.
2-4 week post-discharge
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.
2-4 week post-discharge
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.
2-4 week post-discharge
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.
2-4 week post-discharge
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.
2-4 week post-discharge
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.
2-4 week post-discharge
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.
2-4 week post-discharge
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.
3 month post-discharge
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.
3 month post-discharge
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.
3 month post-discharge
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.
3 month post-discharge
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.
3 month post-discharge
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.
3 month post-discharge
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.
3 month post-discharge
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.
3 month post-discharge
Fidelity
Time Frame: 24-72 hour post-discharge
Percentage of participants with self-reported receipt of both intervention components (intervention arm only).
24-72 hour post-discharge
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).
24-72 hour post-discharge
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).
Documented in EHR at point of intervention delivery over 6 months of maintenance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Philadelphia
National Institute of Nursing Research (NINR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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