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Utvikling og testing av en implementeringsstrategi for en kort, motiverende intervju-basert rådgivningsintervensjon for sikring av dødelige midler i primærhelsetjenesten (CDA-2)

3. november 2026 oppdatert av: VA Office of Research and Development

Utvikling og testing av en implementeringsstrategi for en kort, motivasjonell intervjubasert rådgivningsintervensjon for sikring av dødelige midler i primærhelsetjenesten

Suicide prevention remains a significant priority and nearly three-quarters of Veteran suicides result from firearm injury. Since access to lethal means of self-harm increases the risk of injury, the VA/DoD Clinical Practice Guidelines recommend that Veterans with elevated suicide risk receive lethal means safety (LMS) counseling to reduce access to lethal means, including firearms. However, no LMS counseling interventions have been tested within VA. Thus, the aim of this study is to conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of a tailored LMS counseling intervention compared to an active control condition.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a pilot randomized controlled trial of up to 50 Veterans to assess the feasibility and acceptability of a LMS intervention and testing procedures.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Connecticut
      • West Haven, Connecticut, Forente stater, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Frances Aunon, PhD MS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

For Veterans:

  • Has access to a firearm
  • Referred to Primary Care Mental Health Integration (PCMHI) care

For clinicians (delivering intervention):

  • Deliver care in Primary Care Mental Health Integration (PCMHI)
  • Trained in RAMP and study procedures

Exclusion Criteria:

For Veterans:

  • Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
  • Unreliable telephone access
  • Inability to read English or communicate in spoken and written English

For clinicians (delivering intervention):

- Did not participate in training

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Active control

The control condition will entail a 5-minute review of a pamphlet on suicide prevention with the Primary Care Mental Health Integration (PCMHI) clinician. This pamphlet is produced by the Veteran's Crisis Line and is widely available on the OSP suicide prevention website as a VHA resource. This condition will control for time and attention, subject matter, mode of delivery, and setting.
Atferdsmessig: Active control

The control condition will entail a 5-minute review of a pamphlet on suicide prevention with the Primary Care Mental Health Integration (PCMHI) clinician. This pamphlet is produced by the Veteran's Crisis Line and is widely available on the OSP suicide prevention website as a VHA resource. This condition will control for time and attention, subject matter, mode of delivery, and setting.
Eksperimentell: RAMP

Participants randomized to the intervention condition will receive a brief, motivational interviewing-based intervention called RAMP (Raise the subject, Assess current storage, Motivate change, and Plan next steps) in the context of their clinical care. RAMP incorporates evidence-informed intervention components to facilitate secure firearm storage
Atferdsmessig: RAMP

Participants randomized to the intervention condition will receive a brief, motivational interviewing-based intervention called RAMP (Raise the subject, Assess current storage, Motivate change, and Plan next steps) in the context of their clinical care. RAMP incorporates evidence-informed intervention components to facilitate secure firearm storage

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Screening
Tidsramme: through study completion, approximately 2 years

Investigators will assess the number of new Primary Care Mental Health Integration (PCMHI) patients seen in PCMHI and the number who were approached about potential study participation per month
through study completion, approximately 2 years
Recruitment
Tidsramme: through study completion, approximately 2 years

Investigators will track the number of eligible Veterans who enrolled in the study per month
through study completion, approximately 2 years
Retention
Tidsramme: approximately 30 days

Investigators will calculate the number of Veterans who received RAMP who were willing to complete immediate and one-month follow up assessments.
approximately 30 days
Assessment of behavioral outcomes
Tidsramme: approximately 30 days

Investigators will assess the percentage of participants who completed behavioral outcome measures within the time allotted at each timepoint
approximately 30 days
Veteran acceptability - Theoretical Framework of Acceptability
Tidsramme: At immediate follow up, within approximately 2 weeks of intervention

Investigators will assess Veteran acceptability using the eight Likert-style items from the Theoretical Framework of Acceptability questionnaire, which assess seven component constructs of acceptability including Veteran's experience of the lethal means safety intervention. Each item has 5 answer options (1-5) on a Likert Scale. Score range is 8 to 40, with a higher score indicating more higher reported acceptability.
At immediate follow up, within approximately 2 weeks of intervention
Veteran acceptability - Experience and Satisfaction with intervention
Tidsramme: At immediate follow up, within approximately 2 weeks of intervention

Investigators will conduct qualitative evaluation of the participant's experience and satisfaction receiving the intervention.
At immediate follow up, within approximately 2 weeks of intervention
Clinician acceptability - Theoretical Framework of Acceptability
Tidsramme: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)

Investigators will invite clinicians to respond to the eight-item Theoretical Framework of Acceptability questionnaire eliciting clinician acceptability of the lethal means safety intervention. Each item has 5 answer options (1-5) on a Likert Scale. Score range is 8 to 40, with a higher score indicating more higher reported acceptability.
at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)
Clinician acceptability - Negative impact
Tidsramme: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)

Investigators will assess to what extent Primary Care Mental Health Integration (PCMHI) clinicians agree that study recruitment negatively impacted clinical care, using Likert-type items where '1' indicates "strongly disagree" and '5' indicates "strongly agree." For those responding >3 ("don't know"), an open-ended question will elicit detailed information (e.g., interfered with delivery of clinical care, led to Veteran frustration).
at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VA Office of Research and Development

Etterforskere

  • Hovedetterforsker: Frances Aunon, PhD MS, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2027

Primær fullføring (Antatt)

1. juli 2029

Studiet fullført (Antatt)

31. desember 2031

Datoer for studieregistrering

Først innsendt

14. november 2025

Først innsendt som oppfylte QC-kriteriene

20. november 2025

Først lagt ut (Faktiske)

25. november 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HSR4-001-24W
  • 1IK2RD000503-01A2 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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