Säkerhetsplanering 6+ (HSI)
5 augusti 2026 uppdaterad av: VA Office of Research and Development
Veterancentrerad, ED-baserad Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
Tillgång till dödliga metoder för självskador som skjutvapen och mediciner ökar risken för självmord.
Som sådan inkluderar VA/DoD-riktlinjer för vård av individer med förhöjd självmordsrisk rekommendationer om att läkare levererar insatser för att minska tillgången till dödliga självmordsmetoder bland patienter som identifieras ha förhöjd självmordsrisk.
Däremot har inga ingrepp utvecklats eller testats bland veteraner som söker akutvård - en befolkning som tidigare identifierats ha förhöjd risk.
Syftet med denna studie är att pilottesta en dödlig säkerhetsåtgärd som utvecklats specifikt för veteraner som söker vård på VHA-akutmottagningar och akutvårdsmiljöer och identifieras ha förhöjd självmordsrisk.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Utredarna kommer att pilotera den ED-baserade LMS-interventionen bland upp till 50 veteraner för att bedöma genomförbarhet och acceptans.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
Möte på VHA ED eller akutvårdsinställning
->17 år
- Utskriven hem från akuten (snarare än sjukhusinläggning)
- Självmordsrisken bestäms vara medelhög eller hög baserat på CSRE-resultaten
- Patienten väljer att granska en ny eller uppdaterad säkerhetsplan som en del av sin kliniska vård
- Patientrapporterad tillgång till skjutvapen och/eller mediciner
Exklusions kriterier:
- Kan inte ge sitt samtycke på grund av kognitiv funktionsnedsättning, sjukdomens svårighetsgrad (inklusive psykiatriska symtom), berusning av droger och/eller alkohol
- Otillförlitlig telefonåtkomst
- De som för närvarande upplever oskyddad hemlöshet
- Ingen postadress
- Störning vid användning av aktiva opioid- eller stimulantia
- Aktiv alkoholmissbruk med daglig alkoholkonsumtion
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
|
Denna intervention inkluderar en säkerhetsinsats i hushållet som levereras av en interventionist med specifik utbildning i att underlätta säkerhetsdiskussioner om dödliga medel och tillhandahållande av kostnadsfria säkerhetsanordningar för mediciner och skjutvapen.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility: Number of Participants Recruited Within One Year
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Average Participant Trust in the VA Healthcare System
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 oktober 2024
Primärt slutförande (Faktisk)
18 juli 2025
Avslutad studie (Faktisk)
18 augusti 2025
Studieregistreringsdatum
Först inskickad
20 december 2023
Först inskickad som uppfyllde QC-kriterierna
10 januari 2024
Första postat (Faktisk)
22 januari 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDX 24-001
- 1IK2HX002861-01A2 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .