Sicherheitsplanung 6+ (HSI)
5. August 2026 aktualisiert von: VA Office of Research and Development
Veteranenzentrierte, ED-basierte „Lethal Means Safety Suicide Prevention Intervention“ (CDA 19-076)
Der Zugang zu tödlichen Methoden der Selbstverletzung wie Schusswaffen und Medikamenten erhöht das Selbstmordrisiko.
Daher beinhalten die VA/DoD-Richtlinien für die Betreuung von Personen mit erhöhtem Suizidrisiko Empfehlungen, dass Ärzte Interventionen durchführen sollen, um den Zugang zu tödlichen Suizidmethoden bei Patienten zu reduzieren, bei denen ein erhöhtes Suizidrisiko festgestellt wurde.
Es wurden jedoch keine Interventionen für Veteranen entwickelt oder getestet, die eine Notfallversorgung suchen – eine Population, bei der zuvor ein erhöhtes Risiko festgestellt wurde.
Das Ziel dieser Studie besteht darin, einen Pilottest einer tödlichen Sicherheitsintervention durchzuführen, die speziell für Veteranen entwickelt wurde, die in VHA-Notaufnahmen und Notfallversorgungseinrichtungen Pflege suchen und bei denen festgestellt wurde, dass sie ein erhöhtes Suizidrisiko haben.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Die Forscher werden die ED-basierte LMS-Intervention bei bis zu 50 Veteranen testen, um Durchführbarkeit und Akzeptanz zu beurteilen.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Einschlusskriterien:
Begegnung in der VHA-Notaufnahme oder in der Notfallversorgung
->17 Jahre
- Entlassung aus der Notaufnahme nach Hause (statt Krankenhauseinweisung)
- Basierend auf den CSRE-Ergebnissen wird das Suizidrisiko als mittel oder hoch eingestuft
- Der Patient entscheidet sich dafür, im Rahmen seiner klinischen Versorgung einen neuen oder aktualisierten Sicherheitsplan zu überprüfen
- Vom Patienten gemeldeter Zugang zu Schusswaffen und/oder Medikamenten
Ausschlusskriterien:
- Eine Einwilligung ist aufgrund einer kognitiven Beeinträchtigung, der Schwere der Erkrankung (einschließlich psychiatrischer Symptome), einer Drogen- und/oder Alkoholvergiftung nicht möglich
- Unzuverlässiger Telefonzugang
- Diejenigen, die derzeit ungeschützt obdachlos sind
- Keine Postanschrift
- Aktive Opioid- oder Stimulanzienkonsumstörung
- Aktive Alkoholkonsumstörung mit täglichem Alkoholkonsum
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
|
Diese Intervention umfasst eine Haushaltssicherheitsintervention, die von einem Interventionisten durchgeführt wird, der über eine spezielle Ausbildung in der Moderation von Diskussionen über die Sicherheit tödlicher Mittel verfügt, sowie die Bereitstellung kostenloser Sicherheitsgeräte für Medikamente und Schusswaffen.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility: Number of Participants Recruited Within One Year
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Average Participant Trust in the VA Healthcare System
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
8. Oktober 2024
Primärer Abschluss (Tatsächlich)
18. Juli 2025
Studienabschluss (Tatsächlich)
18. August 2025
Studienanmeldedaten
Zuerst eingereicht
20. Dezember 2023
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Januar 2024
Zuerst gepostet (Tatsächlich)
22. Januar 2024
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CDX 24-001
- 1IK2HX002861-01A2 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .