Firearm SafetyNCT07501247
Trial of a Nurse-Led Firearm Safety Intervention in the Pediatric Inpatient Setting
A study testing Adapted S.A.F.E. Firearm and Implementation bundle in people with Firearm Safety and Suicide, run by University of Pennsylvania at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Firearm Safety, Suicide, Firearm Injury
- What is being tested?
- Adapted S.A.F.E. Firearm and Implementation bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurses who work 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
Who cannot join
- Not a nurse who works on a nursing unit randomized to the intervention arm
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Joel Fein, MD, 610-308-3874, fein@chop.edu
Chelsea Ward McIntosh, MS, 215-590-1244, wardc8@chop.edu
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Katelin Hoskins, PhD, 215-919-0281, hoskinsk@upenn.edu
Katelin Hoskins, PhD
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Firearm Safety, Suicide, Firearm Injury
- Being tested
- Adapted S.A.F.E. Firearm, Implementation bundle
- Keywords
- Firearm safety, Nurse-led intervention
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted S.A.F.E. FirearmBehavioural
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 bundleBehavioural
Electronic health record-based reminder, education, champions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Adapted S.A.F.E. Firearm; Behavioral: Implementation bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Documented in EHR at point of intervention delivery over 1 year of active implementation
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 month post-discharge
Fidelity
Percentage of participants with self-reported receipt of both intervention components (intervention arm only).
Measured: 24-72 hour post-discharge
Acceptability
Percentage of participants with self-reported acceptability of adapted S.A.F.E. Firearm (intervention arm only).
Measured: 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).
Measured: Documented in EHR at point of intervention delivery over 6 months of maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm SafetyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel arm cluster randomized control trial
- Masking
- None (open label)
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501247
- Sponsor's protocol ID
- 857120
- Other IDs
- 1R01NR021259
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Effectiveness-Implementation Trial of a Nurse-Led Firearm Safety Intervention in the Pediatric Inpatient Setting
- ClinicalTrials.gov ID
- NCT07501247
- Acronym / sponsor ID
- 857120
- Conditions
- Firearm Safety, Suicide, Firearm Injury
- Keywords
- Firearm safety, Nurse-led intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel arm cluster randomized control trial
| Arm | Type | Receives |
|---|---|---|
| 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 bundleBehavioral: Adapted S.A.F.E. Firearm; Behavioral: Implementation bundle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nurses who work 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
Key exclusion criteria (5 listed)
- Not a nurse who works on a nursing unit randomized to the intervention arm
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted S.A.F.E. FirearmS.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 | Behavioural | Adapted S.A.F.E. Firearm and implementation bundle |
| Implementation bundleElectronic health record-based reminder, education, champions | Behavioural | Adapted S.A.F.E. Firearm and implementation bundle |
Primary outcome
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.
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).
20 secondary outcomes
Behavioral intention to increase secure firearm storage
Time frame: 24-72 hour post-discharge
Behavioral intention to ask about firearms where child stays/visits
Time frame: 24-72 hour post-discharge
Permanent or temporary removal of firearms
Time frame: 2-4 week post-discharge
Use of cable locks
Time frame: 2-4 week post-discharge
Purchase of additional safety devices
Time frame: 2-4 week post-discharge
Load status
Time frame: 2-4 week post-discharge
Lock and load status combined
Time frame: 2-4 week post-discharge
Ammunition status
Time frame: 2-4 week post-discharge
Inquiry about firearms where child stays/visits
Time frame: 2-4 week post-discharge
Secure storage (3 months)
Time frame: 3 month post-discharge
Permanent or temporary removal of firearms (3 months)
Time frame: 3 month post-discharge
Use of cable locks (3 months)
Time frame: 3 month post-discharge
Purchase of additional safety devices (3 month)
Time frame: 3 month post-discharge
Load status (3 months)
Time frame: 3 month post-discharge
Lock and load status combined (3 months)
Time frame: 3 month post-discharge
Ammunition status (3 months)
Time frame: 3 month post-discharge
Inquiry about firearms where child stays/visits (3 months)
Time frame: 3 month post-discharge
Fidelity
Time frame: 24-72 hour post-discharge
Acceptability
Time frame: 24-72 hour post-discharge
Maintenance
Time frame: Documented in EHR at point of intervention delivery over 6 months of maintenance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Study information on the CHOP Center for Violence Prevention's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted S.A.F.E. Firearm and Implementation bundle in people with Firearm Safety and Suicide, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katelin Hoskins, PhD (215-573-3051, hoskinsk@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secure Storage (time frame: 2-4 week post-discharge, collected over 1 year of active implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.