A Comparative Effectiveness Trial of Strategies to Implement Firearm Safety Promotion as a Universal Suicide Prevention Strategy in Pediatric Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47,307
- 试验地点
- 4
- 主要终点
- Reach
研究概览
简要总结
The objective of this study is to compare two approaches to implement an evidence-based firearm safety promotion program, S.A.F.E. Firearm, in pediatric primary care as a universal suicide prevention strategy. The first implementation approach is a prompt in the electronic health record (EHR; Nudge) reminding clinicians to a) discuss firearm storage and b) offer a free cable firearm lock during the pediatric well visit. The second implementation approach (Nudge+) includes both the EHR Nudge described above plus one year of support to the clinics in deploying the program (i.e., practice facilitation). The study also aims to identify how these strategies work and whether the S.A.F.E. Firearm program results in reduced unauthorized access to firearms by young people. The investigators hypothesize that a greater proportion of well-visits will have S.A.F.E. Firearm delivery documented in the electronic health record in Nudge+ clinics vs. Nudge clinics.
详细描述
The investigators will conduct a hybrid type III effectiveness-implementation trial using a longitudinal cluster randomized design to test the most effective way to implement S.A.F.E. Firearm among 30 clinics, 158 clinicians, and 48,475 youth nested in two Mental Health Research Network (MHRN) health systems in Michigan and Colorado. Clinics will be randomized to receive either the EHR implementation strategy (Nudge) or the EHR implementation strategy plus 1 year of facilitation to target implementation barriers (Nudge+).
Aim 1: Examine the effects of Nudge vs. Nudge+ on implementation outcomes.
- Reach: The investigators hypothesize that clinician-documented program delivery in the EHR (reach; primary outcome) will be superior in the Nudge+ condition compared to Nudge in the active and sustainment periods.
- Fidelity: The investigators hypothesize that parent-reported clinician fidelity to the program will be superior in the Nudge+ condition compared to Nudge in the active and sustainment periods.
- Cost: The investigators will also assess implementation strategy cost.
- Cable Locks/Acceptability: The investigators hypothesize that the Nudge+ condition will result in increased rates of cable lock distribution and higher acceptability compared with Nudge in both the active and sustainment periods.
Aim 2: Use mixed methods to identify implementation strategy mechanisms. The investigators hypothesize that Nudge+ will have a stronger effect because it will improve clinic adaptive reserve (i.e., the ability to make and sustain change). The investigators will also investigate the role of clinician motivation. The investigators hypothesize that clinician attitudes towards firearm counseling, clinician burnout, and clinician demographics will moderate implementation strategy effectiveness.
Aim 3: Examine the effects of the adapted intervention on clinical outcomes. The investigators hypothesize that Nudge+ will result in a greater proportion of parents reporting that they made firearm(s) less accessible to their child(ren) compared with Nudge. The investigators will explore rates of youth suicide attempts, deaths, and unintentional firearm injury and mortality by implementation condition and across time.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents and/or legal guardians (hereafter referred to as parents) at participating pediatric clinics who have a child age 5-17 who attends a well visit. At least one parent must attend the well visit to be eligible. The parent must be at least 18 years old to participate.
排除标准
- •Due to translation costs and challenges of recruiting non-US resident participants, respectively, non-English speaking parents and non-US resident parents will not be eligible to participate at Henry Ford Health System.
- •Inclusion Criteria: Clinicians and leaders
- •Pediatric physicians and non-physician clinicians (hereafter referred to as clinicians) employed within the participating pediatric clinics, as well as health system leaders employed within the two health systems, are eligible to participate. Family medicine clinicians who see pediatric patients in participating clinics at Kaiser Permanente Colorado will also be eligible.
- •Exclusion criteria: Clinicians and leaders
- •At Kaiser Permanente Colorado, family medicine clinicians whose patient panel is comprised of fewer than 5% pediatric patients will be excluded.
- •Family medicine clinicians who see pediatric patients in participating clinics at Henry Ford Health System will be excluded.
结局指标
主要结局
Reach
时间窗: EHR data on reach will be extracted for the time period: the beginning of the active implementation period through the end of the active implementation period (12 months total)
Reach is the proportion of eligible well-child visits who received the S.A.F.E. Firearm program. "Participants" refers to well-child visits. For each well-child visit, data regarding S.A.F.E. Firearm delivery were available in the form of binary indicators, with 1 indicating S.A.F.E. Firearm was delivered during the visit and 0 indicating S.A.F.E. Firearm was not delivered during the visit. Reach outcomes presented below are means of the binary indicators, which were calculated across all eligible well-child visits.
次要结局
- Parent-reported Acceptability(Parent surveys will be collected from parents within two weeks of well-child visit from pre-implementation through sustainment (30 months total))
- Cost(Cost data will be collected from pre-implementation through sustainment (30 months total))
- Fidelity(surveys collected from parents within two weeks of well-child visit. Surveys will be collected during the duration of the pre-implementation, active implementation, and sustainment phases (30 months total))
- Distribution of Cable Locks(Cable lock distribution data will be collected from active implementation through sustainment (24 months total))
- Clinician-reported Acceptability(Clinician surveys will be collected at two time points during the study period: during pre-implementation (surveys will be administered for approximately 1 month) and during active implementation (surveys will be administered for approximately 1 month))
研究者
Rinad Beidas
Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences
Northwestern University