Hybrid Effectiveness-Implementation Trial of a Nurse-Led Firearm Safety Intervention in the Pediatric Inpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,200
- 试验地点
- 2
- 主要终点
- Secure Storage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Data analyst will be blinded to randomization assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Health System Employees):
- •Nurses who work on a nursing unit randomized to the intervention arm
排除标准
- •(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
研究组 & 干预措施
Usual Care
Usual care: routine clinical care plus free cable locks available in the hospital safety center
Adapted S.A.F.E. Firearm and implementation bundle
Behavioral: Adapted S.A.F.E. Firearm;
Behavioral: Implementation bundle
干预措施: Adapted S.A.F.E. Firearm (Behavioral)
Adapted S.A.F.E. Firearm and implementation bundle
Behavioral: Adapted S.A.F.E. Firearm;
Behavioral: Implementation bundle
干预措施: Implementation bundle (Behavioral)
结局指标
主要结局
Secure Storage
时间窗: 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
时间窗: 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).
次要结局
- 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)
- Load status(2-4 week post-discharge)
- Lock and load status combined(2-4 week post-discharge)
- Ammunition status(2-4 week post-discharge)
- Inquiry about firearms where child stays/visits(2-4 week post-discharge)
- Secure storage (3 months)(3 month post-discharge)
- Permanent or temporary removal of firearms (3 months)(3 month post-discharge)
- Use of cable locks (3 months)(3 month post-discharge)
- Purchase of additional safety devices (3 month)(3 month post-discharge)
- Load status (3 months)(3 month post-discharge)
- Lock and load status combined (3 months)(3 month post-discharge)
- Ammunition status (3 months)(3 month post-discharge)
- Inquiry about firearms where child stays/visits (3 months)(3 month post-discharge)
- Fidelity(24-72 hour post-discharge)
- Acceptability(24-72 hour post-discharge)
- Maintenance(Documented in EHR at point of intervention delivery over 6 months of maintenance)