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安全計画 6+ (HSI)

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

退役軍人中心、救急医療に基づいた致死手段の安全な自殺予防介入 (CDA 19-076)

銃器や薬物などの致死的な自傷行為へのアクセスは、自殺のリスクを高めます。 そのため、自殺リスクが高い個人のケアに関する退役軍人省/国防総省のガイドラインには、自殺リスクが高いと特定された患者の致死的自殺方法へのアクセスを減らすために臨床医が介入を行うという推奨事項が含まれている。 しかし、以前にリスクが高いと特定されていた緊急治療を求めている退役軍人を対象とした介入は開発もテストも行われていない。 この研究の目的は、VHA救急部門や救急医療現場で治療を求め、自殺リスクが高いと特定された退役軍人のために特別に開発された致死的手段の安全介入をパイロットテストすることである。

調査の概要

詳細な説明

研究者らは、最大 50 人の退役軍人を対象に ED ベースの LMS 介入を試験的に実施し、実現可能性と受け入れ可能性を評価します。

研究の種類

介入

入学 (実際)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Colorado
      • Aurora、Colorado、アメリカ、80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • VHA ED または救急医療現場での遭遇

    ->17歳

  • EDから(入院ではなく)自宅に退院
  • CSREの結果に基づいて、自殺リスクが中程度または高いと判断される
  • 患者は臨床ケアの一環として、新規または更新された安全計画をレビューすることを選択します
  • 患者が報告した銃器および/または医薬品へのアクセス

除外基準:

  • 認知障害、病気の重症度(精神症状を含む)、薬物および/またはアルコールの中毒により同意できない場合
  • 信頼性の低い電話アクセス
  • 現在、保護されていないホームレス生活を経験している人
  • 郵送先住所がありません
  • 活動性オピオイドまたは覚醒剤使用障害
  • 毎日のアルコール摂取を伴う活動的なアルコール使用障害

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Intervention arm
There is a single intervention arm with no comparator for this pilot study.
この介入には、致死手段の安全性に関する議論を促進するための特別な訓練を受けた介入者によって提供される家庭の安全への介入と、医薬品や銃器用の安全装置の無償提供が含まれます。

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility: Number of Participants Recruited Within One Year
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Average Participant Trust in the VA Healthcare System
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Joseph A Simonetti, MD MPH、Rocky Mountain Regional VA Medical Center, Aurora, CO

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年10月8日

一次修了 (実際)

2025年7月18日

研究の完了 (実際)

2025年8月18日

試験登録日

最初に提出

2023年12月20日

QC基準を満たした最初の提出物

2024年1月10日

最初の投稿 (実際)

2024年1月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月28日

QC基準を満たした最後の更新が送信されました

2026年8月5日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • CDX 24-001
  • 1IK2HX002861-01A2 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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