Planejamento de Segurança 6+ (HSI)
5 de agosto de 2026 atualizado por: VA Office of Research and Development
Intervenção de prevenção de suicídio com meios letais, centrada em veteranos e baseada em DE (CDA 19-076)
O acesso a métodos letais de automutilação, como armas de fogo e medicamentos, aumenta o risco de suicídio.
Como tal, as diretrizes do VA/DoD para o cuidado de indivíduos com risco elevado de suicídio incluem recomendações para que os médicos realizem intervenções para reduzir o acesso a métodos letais de suicídio entre pacientes identificados como tendo risco elevado de suicídio.
No entanto, nenhuma intervenção foi desenvolvida ou testada entre veteranos que procuram cuidados de emergência – uma população previamente identificada como de risco elevado.
O objetivo deste estudo é testar uma intervenção de segurança de meios letais desenvolvida especificamente para veteranos que procuram atendimento em departamentos de emergência da VHA e ambientes de atendimento de urgência e são identificados como tendo risco elevado de suicídio.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Os investigadores irão pilotar a intervenção LMS baseada em ED entre até 50 veteranos para avaliar a viabilidade e aceitabilidade.
Tipo de estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Colorado
-
Aurora, Colorado, Estados Unidos, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
Encontro no VHA ED ou ambiente de atendimento de urgência
->17 anos
- Alta do pronto-socorro para casa (em vez de internação hospitalar)
- O risco de suicídio é determinado como intermediário ou alto com base nos resultados do CSRE
- O paciente opta por revisar um Plano de Segurança novo ou atualizado como parte de seu atendimento clínico
- Acesso relatado pelo paciente a armas de fogo e/ou medicamentos
Critério de exclusão:
- Incapaz de consentir devido a comprometimento cognitivo, gravidade da doença (incluindo sintomas psiquiátricos), intoxicação com drogas e/ou álcool
- Acesso telefônico não confiável
- Aqueles que atualmente vivem em situação de rua desabrigada
- Nenhum endereço postal
- Transtorno por uso ativo de opioides ou estimulantes
- Transtorno por uso ativo de álcool com consumo diário de álcool
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
|
Esta intervenção inclui uma intervenção de segurança doméstica que é ministrada por um intervencionista com formação específica na facilitação de discussões sobre segurança de meios letais e no fornecimento de dispositivos de segurança gratuitos para medicamentos e armas de fogo.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility: Number of Participants Recruited Within One Year
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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at 4 weeks
|
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Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable
Prazo: 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:
|
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
Prazo: 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:
|
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
Prazo: 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:
|
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
Prazo: 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:
|
day of intervention delivery - day 0; and at 4 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Average Participant Trust in the VA Healthcare System
Prazo: 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
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Day of intervention delivery (day 0) and at 4 weeks
|
|
Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
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Average Participant Readiness to Securely Store All Medications
Prazo: 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
Prazo: Day of intervention delivery (day 0) and at 4 weeks
|
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
Prazo: 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:
|
at 4 weeks
|
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Number of Participants With Firearms Present in the Home
Prazo: 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.
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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
Prazo: 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:
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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
Prazo: 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:
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Day of intervention delivery (day 0) and at 4 weeks
|
|
Average Importance of Firearm Ownership for Protection
Prazo: 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
Prazo: 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)
Prazo: 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:
|
Day of intervention delivery (day 0) and at 4 weeks
|
|
Number of Participants With Ammunition in the Home
Prazo: 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
Prazo: 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:
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Day of intervention delivery (day 0) and at 4 weeks
|
|
Number of Participants With Naloxone Prescription in Participant Electronic Health Record
Prazo: at 8 weeks
|
Count of participants who have a naloxone prescription (yes/no).
Verified through each participant's electronic health record.
|
at 8 weeks
|
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Number of Participants With Verified Return of Medication Safety Envelope
Prazo: 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
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de outubro de 2024
Conclusão Primária (Real)
18 de julho de 2025
Conclusão do estudo (Real)
18 de agosto de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
20 de dezembro de 2023
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de janeiro de 2024
Primeira postagem (Real)
22 de janeiro de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CDX 24-001
- 1IK2HX002861-01A2 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .