- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06216327
안전 계획 6+ (HSI)
재향 군인 중심의 ED 기반 치명적인 수단은 안전 자살 예방 개입을 의미합니다(CDA 19-076)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
VHA ED 또는 긴급 치료 환경에서의 만남
->17년
- 응급실에서 집으로 퇴원(병원 입원 아님)
- CSRE 결과에 따라 자살 위험은 중간 또는 높음으로 결정됩니다.
- 환자는 임상 치료의 일부로 신규 또는 업데이트된 안전 계획을 검토하기로 선택합니다.
- 환자가 총기 및/또는 약물에 접근했다고 보고함
제외 기준:
- 인지 장애, 질병의 중증도(정신과적 증상 포함), 약물 및/또는 알코올 중독으로 인해 동의할 수 없는 경우
- 신뢰할 수 없는 전화 접속
- 현재 보호받지 못한 노숙생활을 겪고 있는 사람들
- 우편 주소 없음
- 활성 아편유사제 또는 각성제 사용 장애
- 매일 알코올을 섭취하는 활동성 알코올 사용 장애
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
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이 개입에는 살상 수단 안전 논의 촉진에 대한 특정 교육을 받은 개입 전문가가 제공하는 가정 안전 개입과 약물 및 총기에 대한 무료 안전 장치 제공이 포함됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility: Number of Participants Recruited Within One Year
기간: through study completion, an average of one year
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Ability to recruit 40 Veterans in one year.
Count represents number of participants recruited within one year.
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through study completion, an average of one year
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Feasibility: Number of Participants Who Attend Their 4 Week Follow Up
기간: approximately 4 weeks
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>80% of participants attend their 4 week follow up.
Count represents number of participants who completed their 4 week follow up visit.
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approximately 4 weeks
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Acceptability: Number of Participants With CSQ Scores ≥24
기간: day of intervention delivery - day 0; and at 4 weeks
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>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.
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day of intervention delivery - day 0; and at 4 weeks
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Acceptability: Number of Participants Who Reported the Intervention to be Acceptable
기간: at 4 weeks
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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.
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at 4 weeks
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Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable
기간: day of intervention delivery - day 0; and at 4 weeks
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Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable". "How comfortable did you feel engaging in the discussion?" Likert responses:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions
기간: day of intervention delivery - day 0; and at 4 weeks
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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:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions
기간: day of intervention delivery - day 0; and at 4 weeks
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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:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners
기간: day of intervention delivery - day 0; and at 4 weeks
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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:
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day of intervention delivery - day 0; and at 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Average Participant Trust in the VA Healthcare System
기간: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
기간: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Medication Storage Always
기간: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal
기간: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Firearm Storage Always
기간: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Unloaded Firearm Storage Always
기간: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Readiness to Securely Store All Firearms
기간: Day of intervention delivery - day 0
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"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
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Day of intervention delivery - day 0
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Average Participant Readiness to Securely Store All Medications
기간: Day of intervention delivery at visit #1 (day 0)
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"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
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Day of intervention delivery at visit #1 (day 0)
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Average Number of Firearms in Household
기간: Day of intervention delivery (day 0) and at 4 weeks
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Number of firearms in household: Answer range: 0 to 10,000
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Who Forget to Take Their Medications Often/Always
기간: at 4 weeks
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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:
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at 4 weeks
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Number of Participants With Firearms Present in the Home
기간: Day of intervention delivery (day 0) and at 4 weeks
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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.
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Securely Storing All Firearms
기간: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Securely Storing All Medications
기간: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Average Importance of Firearm Ownership for Protection
기간: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust
기간: Day of intervention delivery (day 0)
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"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
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Day of intervention delivery (day 0)
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Number of Participants Who Do Not Have Access to Locked Firearm(s)
기간: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With Ammunition in the Home
기간: Day of intervention delivery (day 0) and at 4 weeks
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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.
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With All Ammunition Locked
기간: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With Naloxone Prescription in Participant Electronic Health Record
기간: at 8 weeks
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Count of participants who have a naloxone prescription (yes/no).
Verified through each participant's electronic health record.
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at 8 weeks
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Number of Participants With Verified Return of Medication Safety Envelope
기간: at 8 weeks
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Verification of returned medication safety envelope (yes/no).
Count represents number of participants who utilized their medication return envelope.
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at 8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .