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安全规划 6+ (HSI)

2026年8月5日 更新者:VA Office of Research and Development

以退伍军人为中心、基于急诊室的致命手段安全自杀预防干预 (CDA 19-076)

使用枪支和药物等致命的自残方法会增加自杀风险。 因此,退伍军人管理局/国防部关于自杀风险较高个人的护理指南包括建议临床医生采取干预措施,以减少被确定为自杀风险较高的患者使用致命自杀方法的机会。 然而,尚未在寻求紧急护理的退伍军人中开发或测试任何干预措施,而这些人之前被认为具有较高的风险。 这项研究的目的是试点测试专门为在 VHA 急诊室和紧急护理机构寻求护理并被确定自杀风险较高的退伍军人开发的致命手段安全干预措施。

研究概览

地位

完全的

详细说明

研究人员将在最多 50 名退伍军人中试点基于 ED 的 LMS 干预措施,以评估可行性和可接受性。

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Aurora、Colorado、美国、80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准:

  • 在 VHA 急诊室或紧急护理机构遇到

    ->17岁

  • 从急诊室出院(而不是入院)
  • 根据 CSRE 结果确定自杀风险为中度或高度
  • 患者选择审查新的或更新的安全计划作为其临床护理的一部分
  • 患者报告的枪支和/或药物获取情况

排除标准:

  • 由于认知障碍、疾病严重程度(包括精神症状)、药物和/或酒精中毒而无法同意
  • 电话接入不可靠
  • 那些目前无家可归的人
  • 没有邮寄地址
  • 活性阿片类药物或兴奋剂使用障碍
  • 每日饮酒的活动性酒精使用障碍

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention arm
There is a single intervention arm with no comparator for this pilot study.
这种干预措施包括家庭安全干预措施,由接受过促进致命手段安全讨论的专门培训的干预人员提供,并提供免费的药物和枪支安全装置。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Feasibility: Number of Participants Recruited Within One Year
大体时间:through study completion, an average of one year
Ability to recruit 40 Veterans in one year. Count represents number of participants recruited within one year.
through study completion, an average of one year
Feasibility: Number of Participants Who Attend Their 4 Week Follow Up
大体时间:approximately 4 weeks
>80% of participants attend their 4 week follow up. Count represents number of participants who completed their 4 week follow up visit.
approximately 4 weeks
Acceptability: Number of Participants With CSQ Scores ≥24
大体时间:day of intervention delivery - day 0; and at 4 weeks
>80% with score greater than 23 (Client Satisfaction Questionnaire 8). 8 items, each with 4 answer options (1-4) on a Likert Scale. Likert options are different for each item. Score range is 8 to 32. Higher scores indicate higher satisfaction.
day of intervention delivery - day 0; and at 4 weeks
Acceptability: Number of Participants Who Reported the Intervention to be Acceptable
大体时间:at 4 weeks
Count of participants who deemed the intervention acceptable via a qualitative evaluation of participant's experiences during the intervention. Assessed using the Narrative Evaluation of Intervention Interview (NEII): A 16-item semi-structured qualitative interview that helps participants evaluate the process and outcome of interventions.
at 4 weeks
Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable
大体时间:day of intervention delivery - day 0; and at 4 weeks

Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable".

"How comfortable did you feel engaging in the discussion?"

Likert responses:

  • Very uncomfortable
  • Uncomfortable
  • Neither
  • Comfortable
  • Very comfortable
day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions
大体时间:day of intervention delivery - day 0; and at 4 weeks

Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful".

"How helpful was your interaction in making decisions about medication storage and safety?"

Likert responses:

  • Not at all
  • Slightly helpful
  • Moderately helpful
  • Very helpful
  • Extremely helpful
day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions
大体时间:day of intervention delivery - day 0; and at 4 weeks

Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful".

"How helpful was your interaction in making decisions about firearm storage?"

Likert responses:

  • Not at all
  • Slightly helpful
  • Moderately helpful
  • Very helpful
  • Extremely helpful
day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners
大体时间:day of intervention delivery - day 0; and at 4 weeks

Count represents the number of participants who reported that their interaction was "Respectful" or "Very respectful".

"To what extent was this intervention respectful of your values as a firearm owner?

Likert responses:

  • Very disrespectful
  • Disrespectful
  • Neither
  • Respectful
  • Very respectful
day of intervention delivery - day 0; and at 4 weeks

次要结果测量

结果测量
措施说明
大体时间
Average Participant Trust in the VA Healthcare System
大体时间:Day of intervention delivery (day 0) and at 4 weeks
"On a scale from 0 to 10, where 10 indicates complete trust and 0 indicates complete distrust (so 5 would indicate that you neither trust, nor distrust), Please indicate your level of trust in the VA healthcare system?" Answer range: 0-10
Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
大体时间:Day of intervention delivery (day 0) and at 4 weeks
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is important to securely store medications when I or someone in my household has had recent thoughts of suicide." Answer range: 0-10
Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Medication Storage Always
大体时间:Day of intervention delivery (day 0) and at 4 weeks
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to securely store medications even if someone is not at risk for suicide in the home." Answer range: 0-10
Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal
大体时间:Day of intervention delivery (day 0) and at 4 weeks
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is important to securely store firearms when I or someone in my household has had recent thoughts of suicide." Answer range: 0-10
Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Firearm Storage Always
大体时间:Day of intervention delivery (day 0) and at 4 weeks
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to store firearms securely in a locked space, or with a locking device, even if someone is not at risk for suicide in the home." Answer range: 0-10
Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Unloaded Firearm Storage Always
大体时间:Day of intervention delivery (day 0) and at 4 weeks
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to securely store firearms unloaded even if someone is not at risk for suicide in the home." Answer range: 0-10
Day of intervention delivery (day 0) and at 4 weeks
Average Participant Readiness to Securely Store All Firearms
大体时间:Day of intervention delivery - day 0
"One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all firearms. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10
Day of intervention delivery - day 0
Average Participant Readiness to Securely Store All Medications
大体时间:Day of intervention delivery at visit #1 (day 0)
"One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all medications. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change]?" Answer range: 0-10
Day of intervention delivery at visit #1 (day 0)
Average Number of Firearms in Household
大体时间:Day of intervention delivery (day 0) and at 4 weeks
Number of firearms in household: Answer range: 0 to 10,000
Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Who Forget to Take Their Medications Often/Always
大体时间:at 4 weeks

Count represents number of participants who said 'very often' or 'always'. "To what extent have you had difficulty remembering to take your medications in the past month?"

Likert responses:

  • Never
  • Rarely
  • Sometimes
  • Very Often
  • Always
at 4 weeks
Number of Participants With Firearms Present in the Home
大体时间:Day of intervention delivery (day 0) and at 4 weeks
Changes in whether household firearms are present in a participant's home from day of intervention delivery (day 0) to 4 weeks. Count represents the number of participants who reported having at least 1 firearm in their home.
Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Firearms
大体时间:Day of intervention delivery (day 0) and at 4 weeks

Changes in whether household firearms are stored securely. Count represents number of participants who had 'all' firearms locked.

"Are any firearms in or around your home currently stored locked?"

Answers:

  • Yes, all of them are locked
  • Yes, some of them are locked
  • None of them are locked
  • I'm not sure
  • Decline to respond
Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Medications
大体时间:Day of intervention delivery (day 0) and at 4 weeks

Changes in whether present medication are all stored securely. Count represents the number of participants who stored 'all' of their medications locked.

"Are the medications in your home currently stored locked? (Examples include using a locked cabinet or box)"

Answer options:

  • Yes, all of the medications in my home are locked up
  • Yes, some of the medications in my home are locked up
  • None of the medications in my home are locked up
  • I'm not sure
Day of intervention delivery (day 0) and at 4 weeks
Average Importance of Firearm Ownership for Protection
大体时间:Day of intervention delivery (day 0) and at 4 weeks
"On a scale of 0 to 10, to what extent do you keep your firearms to protect yourself or your loved ones from other people? Someone who answers 0 does not consider themselves to keep firearms for protection, while someone who answers 10 considers that their firearms are absolutely required for protection." Answer range: 0-10
Day of intervention delivery (day 0) and at 4 weeks
Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust
大体时间:Day of intervention delivery (day 0)
"One of the safest things someone can do while they're going through a difficult time is to store their firearms outside of the home with someone they trust. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10
Day of intervention delivery (day 0)
Number of Participants Who Do Not Have Access to Locked Firearm(s)
大体时间:Day of intervention delivery (day 0) and at 4 weeks

Count of people who said they do not have access to the key/combination for their locked firearm.

"For the firearms in your home that are locked, who has access to the keys or number combinations that would be needed to access them?"

Answer options:

  • You
  • Your spouse or partner
  • Children under the age of 18 years
  • Children 18 years of age or older
  • A friend
  • A neighbor
  • Other:__________
Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Ammunition in the Home
大体时间:Day of intervention delivery (day 0) and at 4 weeks
Changes from day of intervention delivery (day 0) to 4 weeks in whether household ammunition is present. The presence of ammunition in the home was only asked to participants who stated there were firearms in the home and that they were the owner of at least 1 of the firearms in the home. Count represents number of participants who reported having ammunition in the home.
Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With All Ammunition Locked
大体时间:Day of intervention delivery (day 0) and at 4 weeks

Count of participants who reported having 'all' ammunition in the home securely locked. This measure was only asked to participants who reported that there were firearms in the home, that they were the owner of at least 1 of the firearms in the home, and that there was ammunition in the home.

"Is ammunition in or around your home currently stored in a locked place, such as a locked cabinet?"

Answer options:

  • Yes, all of the ammunition is locked
  • Yes, some of the ammunition is locked
  • None of the ammunition is locked
  • I'm not sure
  • No ammunition is in my home
Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Naloxone Prescription in Participant Electronic Health Record
大体时间:at 8 weeks
Count of participants who have a naloxone prescription (yes/no). Verified through each participant's electronic health record.
at 8 weeks
Number of Participants With Verified Return of Medication Safety Envelope
大体时间:at 8 weeks
Verification of returned medication safety envelope (yes/no). Count represents number of participants who utilized their medication return envelope.
at 8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Joseph A Simonetti, MD MPH、Rocky Mountain Regional VA Medical Center, Aurora, CO

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月8日

初级完成 (实际的)

2025年7月18日

研究完成 (实际的)

2025年8月18日

研究注册日期

首次提交

2023年12月20日

首先提交符合 QC 标准的

2024年1月10日

首次发布 (实际的)

2024年1月22日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月5日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CDX 24-001
  • 1IK2HX002861-01A2 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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