Firearm Injury, Firearm Safety, Suicide
Conditions
Keywords
Firearm safety, Nurse-led intervention
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.
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.
Interventions
BEHAVIORALAdapted 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
BEHAVIORALImplementation bundle
Electronic health record-based reminder, education, champions
Sponsors
University of Pennsylvania
National Institute of Nursing Research (NINR)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Data analyst will be blinded to randomization assignment
Intervention model description
Parallel arm cluster randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secure Storage | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Behavioral intention to increase secure firearm storage | 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. |
| Behavioral intention to ask about firearms where child stays/visits | 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. |
| Permanent or temporary removal of firearms | 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. |
| Use of cable locks | 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. |
| Purchase of additional safety devices | 2-4 week post-discharge | Percentage of participants with self-reported purchase of additional firearm safety devices. Categories: yes, no, prefer not to answer. |
| Load status | 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. |
| Lock and load status combined | 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. |
| Ammunition status | 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. |
| Inquiry about firearms where child stays/visits | 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. |
| Secure storage (3 months) | 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. |
| Permanent or temporary removal of firearms (3 months) | 3 month post-discharge | Percentage of participants with self-reported permanent or temporary removal of firearms from the household. Categories: Any removal, no removal. |
| Use of cable locks (3 months) | 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. |
| Purchase of additional safety devices (3 month) | 3 month post-discharge | Percentage of participants with self-reported purchase of additional firearm safety devices. Categories: yes, no, prefer not to answer. |
| Load status (3 months) | 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. |
| Lock and load status combined (3 months) | 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. |
| Ammunition status (3 months) | 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. |
| Inquiry about firearms where child stays/visits (3 months) | 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. |
| Fidelity | 24-72 hour post-discharge | Percentage of participants with self-reported receipt of both intervention components (intervention arm only). |
| Acceptability | 24-72 hour post-discharge | Percentage of participants with self-reported acceptability of adapted S.A.F.E. Firearm (intervention arm only). |
| Maintenance | 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). |
Countries
United States
Contacts
CONTACTKatelin Hoskins, PhD
CONTACTChelsea Ward McIntosh, MS
Outcome results
None listed