Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings
13. april 2022 opdateret af: NYU Langone Health
Leveraging Technology to Address Unhealthy Drug Use in Primary Care: Effectiveness of the Substance Use Screening and Intervention Tool (SUSIT)
This study will develop a clinical decision support tool that assists primary care providers in carrying out substance use interventions, and then compare (in Phase 2) two clinical scenarios, screening only (SO) vs. SUSIT, (on dose of substance use brief intervention received) and changes in drug use at 3 and 6 months, among primary care patients.
Investigators will develop the Clinical Decision Support (CDS) component and then test the full SUSIT approach, using mixed methods to assess its acceptability and adoption, and gathering preliminary data on its efficacy for reducing unhealthy drug use.
CDS development is concurrent with the SO phase to avoid losing valuable time, but will be conducted at a secondary study site to avoid contaminating the SO condition.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study has 3 specific aims:
Aim 1 is to develop clinical decision support that assists primary care providers in carrying out a brief intervention.
Aim 2 is to assess the impact of the SUSIT on dose of substance use brief intervention received by patients.
Aim 3 is to gather preliminary evidence on the efficacy of the SUSIT approach for reducing moderate-risk drug use.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
79
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New York
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New York, New York, Forenede Stater, 10016
- New York University School of Medicine
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Substance use screening results (collected using the tablet-based screening tool) indicating current moderate risk drug use, based on a substance specific involvement score (SSIS) indicating current (past 3 months) use of at least one drug with a moderate risk level (SSIS 4-26), in the absence of any high-risk drug or alcohol use (SSIS 27+);
- Presenting for visit with a participating PCP
Exclusion Criteria:
- Prior participation in the study (i.e. participation in the SO study phase would preclude participation in the SUSIT phase);
- Attending a formal addiction treatment program (not including informal treatment such as Alcoholics Anonymous, Narcotics Anonymous), in the past 3 months;
- Pregnant (based on self-report).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Screening Only (SO)
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Patient and PCP are not presented with screening results.
The PCP does not receive clinical decision support, or clinical reminders.
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Eksperimentel: Substance Use Screening and Intervention Tool (SUSIT)
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Following completion of substance use screening, the tablet computer presents screening results (including level of risk) to the patient for each substance used, asks them to identify their drug of most concern (DOMC), and assesses readiness and confidence to change behavior.
Results are delivered to the PCP at the point of care, paired with clinical decision support tailored to the patient's screening results.
This information is delivered on the tablet computer, which is handed to the PCP by a Medical Assistant.
CDS guides the PCP through a brief intervention specific to the DOMC, recommends clinical actions pertaining to the substance and risk level, and generates a printed summary for the patient.
At each scheduled follow-up medical visit, the PCP receives a clinical reminder containing a summary of the patient's substance use and level of risk, paired with CDS that guides them through a follow-up brief intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit
Tidsramme: Baseline
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Reported by Patients
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Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jennifer McNeely, MD, MS, NYU Langone Health
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)
13. april 2017
Primær færdiggørelse (Faktiske)
30. marts 2019
Studieafslutning (Faktiske)
31. juli 2019
Datoer for studieregistrering
Først indsendt
11. august 2016
Først indsendt, der opfyldte QC-kriterier
2. september 2016
Først opslået (Skøn)
8. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-01074
- 1R34DA040830-01 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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