Planification de la sécurité 6+ (HSI)
5 août 2026 mis à jour par: VA Office of Research and Development
Intervention de prévention du suicide axée sur les vétérans et basée sur les moyens mortels (CDA 19-076)
L’accès à des méthodes mortelles d’automutilation telles que les armes à feu et les médicaments augmente le risque de suicide.
À ce titre, les lignes directrices du VA/DoD pour la prise en charge des personnes présentant un risque de suicide élevé incluent des recommandations selon lesquelles les cliniciens doivent intervenir pour réduire l'accès aux méthodes mortelles de suicide chez les patients identifiés comme présentant un risque de suicide élevé.
Cependant, aucune intervention n'a été développée ou testée auprès des vétérans recherchant des soins d'urgence - une population précédemment identifiée comme présentant un risque élevé.
Le but de cette étude est de tester une intervention de sécurité par des moyens mortels développée spécifiquement pour les vétérans qui recherchent des soins dans les services d'urgence de la VHA et les établissements de soins d'urgence et sont identifiés comme ayant un risque de suicide élevé.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Les enquêteurs piloteront l'intervention LMS basée sur l'ED auprès d'un maximum de 50 vétérans pour évaluer la faisabilité et l'acceptabilité.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Colorado
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Aurora, Colorado, États-Unis, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Critère d'intégration:
Rencontre au VHA ED ou dans un établissement de soins d'urgence
->17 ans
- Sortie de l'urgence (plutôt que admission à l'hôpital)
- Le risque de suicide est jugé intermédiaire ou élevé sur la base des résultats du CSRE
- Le patient choisit d'examiner un plan de sécurité nouveau ou mis à jour dans le cadre de ses soins cliniques
- Accès déclaré par le patient à des armes à feu et/ou à des médicaments
Critère d'exclusion:
- Incapacité de consentir en raison d'un déficit cognitif, de la gravité de la maladie (y compris des symptômes psychiatriques), d'une intoxication par des drogues et/ou de l'alcool
- Accès téléphonique peu fiable
- Ceux qui sont actuellement sans abri
- Aucune adresse postale
- Trouble lié à la consommation active d'opioïdes ou de stimulants
- Trouble de consommation active d'alcool avec consommation quotidienne d'alcool
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
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Cette intervention comprend une intervention de sécurité domestique dispensée par un intervenant ayant une formation spécifique pour faciliter les discussions sur la sécurité des moyens mortels et la fourniture de dispositifs de sécurité gratuits pour les médicaments et les armes à feu.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility: Number of Participants Recruited Within One Year
Délai: 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
|
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Feasibility: Number of Participants Who Attend Their 4 Week Follow Up
Délai: 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
|
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Acceptability: Number of Participants With CSQ Scores ≥24
Délai: 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.
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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
Délai: 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
Délai: 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
|
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Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions
Délai: 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:
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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
Délai: 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
|
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Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Average Participant Trust in the VA Healthcare System
Délai: 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
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Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
Délai: 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
Délai: 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
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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
Délai: 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
|
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Average Participant Beliefs About Importance of Secure Firearm Storage Always
Délai: 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
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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
Délai: 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
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Average Importance of Firearm Ownership for Protection
Délai: 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
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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
Délai: 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
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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)
Délai: 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:
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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
Délai: 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.
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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
Délai: 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
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Number of Participants With Naloxone Prescription in Participant Electronic Health Record
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 octobre 2024
Achèvement primaire (Réel)
18 juillet 2025
Achèvement de l'étude (Réel)
18 août 2025
Dates d'inscription aux études
Première soumission
20 décembre 2023
Première soumission répondant aux critères de contrôle qualité
10 janvier 2024
Première publication (Réel)
22 janvier 2024
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDX 24-001
- 1IK2HX002861-01A2 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .