Pianificazione della sicurezza 6+ (HSI)
5 agosto 2026 aggiornato da: VA Office of Research and Development
Intervento di prevenzione del suicidio di sicurezza con mezzi letali incentrato sui veterani e basato sull'ED (CDA 19-076)
L’accesso a metodi letali di autolesionismo come armi da fuoco e farmaci aumenta il rischio di suicidio.
Pertanto, le linee guida VA/DoD per la cura di individui con elevato rischio di suicidio includono raccomandazioni affinché i medici forniscano interventi per ridurre l’accesso a metodi letali di suicidio tra i pazienti identificati come aventi un elevato rischio di suicidio.
Tuttavia, nessun intervento è stato sviluppato o testato tra i veterani che necessitano di cure di emergenza, una popolazione precedentemente identificata come a rischio elevato.
Lo scopo di questo studio è testare un intervento di sicurezza con mezzi letali sviluppato appositamente per i veterani che cercano assistenza nei reparti di emergenza VHA e in contesti di assistenza urgente e sono identificati come aventi un elevato rischio di suicidio.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
I ricercatori sperimenteranno l'intervento LMS basato su ED tra un massimo di 50 veterani per valutare la fattibilità e l'accettabilità.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
Incontro al VHA ED o in un contesto di cure urgenti
->17 anni
- Dimesso a casa dal pronto soccorso (piuttosto che ricovero in ospedale)
- Il rischio di suicidio è determinato come intermedio o alto in base ai risultati del CSRE
- Il paziente sceglie di rivedere un piano di sicurezza nuovo o aggiornato come parte della sua assistenza clinica
- Accesso segnalato dal paziente ad armi da fuoco e/o farmaci
Criteri di esclusione:
- Incapacità di dare il consenso a causa di deterioramento cognitivo, gravità della malattia (compresi sintomi psichiatrici), intossicazione da droghe e/o alcol
- Accesso telefonico inaffidabile
- Coloro che attualmente vivono senza fissa dimora
- Nessun indirizzo postale
- Disturbo da uso attivo di oppioidi o stimolanti
- Disturbo da consumo attivo di alcol con consumo quotidiano di alcol
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
|
Questo intervento include un intervento sulla sicurezza domestica fornito da un interventista con una formazione specifica nel facilitare le discussioni sulla sicurezza dei mezzi letali e la fornitura di dispositivi di sicurezza gratuiti per farmaci e armi da fuoco.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility: Number of Participants Recruited Within One Year
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Average Participant Trust in the VA Healthcare System
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Number of Participants With Firearms Present in the Home
Lasso di tempo: 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
Lasso di tempo: 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:
|
Day of intervention delivery (day 0) and at 4 weeks
|
|
Number of Participants Securely Storing All Medications
Lasso di tempo: 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:
|
Day of intervention delivery (day 0) and at 4 weeks
|
|
Average Importance of Firearm Ownership for Protection
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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:
|
Day of intervention delivery (day 0) and at 4 weeks
|
|
Number of Participants With Naloxone Prescription in Participant Electronic Health Record
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 ottobre 2024
Completamento primario (Effettivo)
18 luglio 2025
Completamento dello studio (Effettivo)
18 agosto 2025
Date di iscrizione allo studio
Primo inviato
20 dicembre 2023
Primo inviato che soddisfa i criteri di controllo qualità
10 gennaio 2024
Primo Inserito (Effettivo)
22 gennaio 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDX 24-001
- 1IK2HX002861-01A2 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .