Sikkerhedsplanlægning 6+ (HSI)
5. august 2026 opdateret af: VA Office of Research and Development
Veterancentreret, ED-baseret dødelig midler sikkerhed Selvmordsforebyggende intervention (CDA 19-076)
Adgang til dødelige metoder til selvskade som skydevåben og medicin øger risikoen for selvmord.
Som sådan inkluderer VA/DoD-retningslinjer for pleje af personer med forhøjet selvmordsrisiko anbefalinger om, at klinikere leverer interventioner for at reducere adgangen til dødelige selvmordsmetoder blandt patienter, der er identificeret som havende forhøjet selvmordsrisiko.
Der er dog ikke udviklet eller testet nogen interventioner blandt veteraner, der søger akuthjælp - en befolkning, der tidligere er identificeret som havende forhøjet risiko.
Formålet med denne undersøgelse er at pilotteste en dødelig sikkerhedsintervention udviklet specifikt til veteraner, der søger pleje i VHA akutafdelinger og akutte plejemiljøer og er identificeret som havende forhøjet selvmordsrisiko.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Efterforskerne vil pilotere den ED-baserede LMS-intervention blandt op til 50 veteraner for at vurdere gennemførlighed og acceptabilitet.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
Møde på VHA ED eller akut behandling
->17 år
- Udskrevet hjem fra ED (i stedet for hospitalsindlæggelse)
- Selvmordsrisikoen bestemmes til at være mellem eller høj baseret på CSRE-resultaterne
- Patienten vælger at gennemgå en ny eller opdateret sikkerhedsplan som en del af deres kliniske behandling
- Patientrapporteret adgang til skydevåben og/eller medicin
Ekskluderingskriterier:
- Ude af stand til at give samtykke på grund af kognitiv svækkelse, sygdoms sværhedsgrad (inklusive psykiatriske symptomer), forgiftning med stoffer og/eller alkohol
- Upålidelig telefonadgang
- Dem, der i øjeblikket oplever uskærmet hjemløshed
- Ingen postadresse
- Aktiv opioid- eller stimulerende brugsforstyrrelse
- Aktiv alkoholmisbrug med dagligt alkoholforbrug
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
|
Denne intervention omfatter en husstandssikkerhedsintervention, der leveres af en interventionist med specifik træning i at lette sikkerhedsdiskussioner om dødelige midler og tilvejebringelse af gratis sikkerhedsanordninger til medicin og skydevåben.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility: Number of Participants Recruited Within One Year
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Average Participant Trust in the VA Healthcare System
Tidsramme: 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
Tidsramme: 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
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Day of intervention delivery (day 0) and at 4 weeks
|
|
Average Participant Beliefs About Importance of Secure Medication Storage Always
Tidsramme: 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
|
|
Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
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Average Number of Firearms in Household
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
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Number of Participants Who Do Not Have Access to Locked Firearm(s)
Tidsramme: 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
|
|
Number of Participants With Ammunition in the Home
Tidsramme: 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
Tidsramme: 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
Tidsramme: at 8 weeks
|
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
Tidsramme: at 8 weeks
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. oktober 2024
Primær færdiggørelse (Faktiske)
18. juli 2025
Studieafslutning (Faktiske)
18. august 2025
Datoer for studieregistrering
Først indsendt
20. december 2023
Først indsendt, der opfyldte QC-kriterier
10. januar 2024
Først opslået (Faktiske)
22. januar 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDX 24-001
- 1IK2HX002861-01A2 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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