Evaluating a Digital Toolkit for IPV
14. mai 2026 oppdatert av: Medical University of South Carolina
A Stepped-Wedge Randomized Controlled Trial Evaluating a Digital Toolkit for IPV
The study evaluates a web-based digital toolkit designed to screen for intimate partner violence (IPV), post-traumatic stress disorder (PTSD), and related mental health concerns within opioid treatment programs.
Providers use the toolkit during routine care with patients receiving treatment for opioid use disorder.
The study examines how the toolkit is implemented into clinic workflows and whether its use improves detection, referral, and patient outcomes.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
792
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ariel Worley, MPH
- Telefonnummer: (843) 792-8208
- E-post: worleyar@musc.edu
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion criteria for all participants:
- Age 18 and older
- Able to understand and sign a consent form in English
Inclusion criteria for OTPs:
- Current experience working in one of the three opioid treatment clinics serving as a recruitment site for this study
- Health care professional training (e.g., social worker, counselor, physician, psychologist, nurse practitioner)
Exclusion criteria for OTPs:
- None
Inclusion criteria for patients with OUD:
- Report opioids as their primary substance of use for which they are seeking treatment
- Receive treatment at one of the three opioid treatment clinics serving as a recruitment site for this study
Exclusion criteria for patients with OUD:
- An acute medical problem requiring inpatient treatment (e.g., detoxification)
- Incarceration at the time of the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Treatment as Usual
Treatment as usual consists of screening and care practices as usual, as provided by the clinic setting
|
|
|
Eksperimentell: Digital Toolkit
Digital toolkit used for screening and providing referral/treatment planning information for intimate partner violence and mental health conditions
|
The digital toolkit intervention consists of validated tools to screen patients for intimate partner violence and mental health conditions and evidence-based suggestions for personalized treatment plans and/or referrals
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients who receive screening
Tidsramme: From enrollment until the end of study participation at (up to) 35 months
|
Proportion of patients seen who receive intimate partner violence and mental health screening
|
From enrollment until the end of study participation at (up to) 35 months
|
|
Proportion of patients screened positive for intimate partner violence
Tidsramme: From enrollment until the end of study participation at (up to) 35 months
|
Proportion of patients screened who screen positive for intimate partner violence
|
From enrollment until the end of study participation at (up to) 35 months
|
|
Proportion of intimate partner violence-positive patients who receive recommended or referred services
Tidsramme: From enrollment until the end of study participation at (up to) 35 months
|
Proportion of patients screened positive for intimate partner violence who received recommended or referred services for intimate partner violence
|
From enrollment until the end of study participation at (up to) 35 months
|
|
Proportion of patients retained on MOUD following intimate partner violence and mental health screening
Tidsramme: From enrollment until the end of study participation at (up to) 35 months
|
Proportion of patients retained in MOUD services for at least 18 months following intimate partner violence and mental health screening
|
From enrollment until the end of study participation at (up to) 35 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of providers completing intimate partner violence and mental health screening
Tidsramme: From enrollment until the end of study participation at (up to) 35 months
|
Proportion of providers completing intimate partner violence and mental health screening with at least 70% of eligible patients
|
From enrollment until the end of study participation at (up to) 35 months
|
|
Proportion of providers providing resources and referrals for patients who screened positive for intimate partner violence
Tidsramme: From enrollment until the end of study participation at (up to) 35 months
|
Proportion of providers who provided resources and/or referrals for patients who screened positive for intimate partner violence
|
From enrollment until the end of study participation at (up to) 35 months
|
|
Proportion of providers who had patients accept referrals and/or attempted to attend recommended psychosocial services
Tidsramme: From enrollment until the end of study participation at (up to) 35 months
|
Proportion of providers for whom at least 60% of patients accepted referrals and/or attempted to attend recommended psychosocial services
|
From enrollment until the end of study participation at (up to) 35 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Amber M Jarnecke, PhD, Medical University of South Carolina
- Hovedetterforsker: Tanya C Saraiya, PhD, Medical University of South Carolina
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. desember 2026
Primær fullføring (Antatt)
1. august 2030
Studiet fullført (Antatt)
1. august 2030
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
14. mai 2026
Først lagt ut (Faktiske)
20. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00151072
- 1R61DA061371 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Demographic, survey, and clinical data will be acquired.
The raw interview, survey, and clinical data will be stored within a secure computing environment.
All direct identifiers will be removed and maintained in a secure file.
All other scientific data (coded interview data, scale composites, recodes) will be both preserved and shared via ICPSR.
Documentation to be made available will include a study protocol, reference to study publication of primary outcomes, data sets, case report forms, a data dictionary, and study-specific notes.
Variables in the data dictionary will include a description, variable name, variable label, and standard codes for missing values.
IPD-delingstidsramme
The first batch of data will be deposited 6 months after enrollment of the first participants and data will be deposited every 6 months thereafter until study completion.
The research community will have access to the full data set approximately 18 months following the end of the randomized clinical trial or after the primary paper has been accepted for publication, whichever happens first.
Tilgangskriterier for IPD-deling
Data will be findable for the research community through ICPSR.
For all publications, an ICPSR study will be created and assigned a digital object identifier (DOI).
The DOI will be referenced in the publication to allow the research community to access the data used.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .