- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02408952
Screening for unges alkohol- og stofbrug: En undersøgelse af primære omsorgsudbydere
14. juli 2023 opdateret af: Kaiser Permanente
Denne undersøgelse evaluerer implementeringen og effektiviteten af to modaliteter af screening, kort intervention og henvisning til behandling (SBIRT) for at reducere alkohol- og andre lægemidler (AOD) hos unge i en stor pædiatrisk klinik.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sundhedssystemer har ikke implementeret screening, kort intervention og henvisning til behandling (SBIRT) for unge på trods af forskning, der viser dets effektivitet.
Baseret på tidligere forskning, der identificerede barrierer for AOD-screening for unge i pædiatrisk Primary Care (PC) og en pilotundersøgelse, der fandt, at SBIRT var gennemførligt, godt modtaget og fremmet henvisninger til og initiering af specialbehandling, foreslår den aktuelle forskningsansøgning at randomisere 45 Primary Care Physicians (PCP'er) i den pædiatriske klinik på et lægecenter i et stort, administreret sundhedssystem, Kaiser Permanente Northern California, til tre arme - 1) Sædvanlig pleje; 2) SBIRT leveret af PCP'er; og 3) SBIRT leveret af Behavioural Medicine Specialists (BMS).
Formålet med undersøgelsen er at sammenligne implementeringen, effektiviteten og omkostningseffektiviteten af SBIRT for unge i PC i de tre undersøgelsesarme.
Patienterne vil gennemføre evidensbaseret screening og AOD-vurderingsforanstaltninger, som er indlejret i sundhedsplanens elektroniske journal (EMR).
En blandet model vil blive brugt til at sammenligne implementeringsresultater (hastigheder for screening og identifikation, kort intervention, henvisning til behandling med kemisk afhængighed og behandlingsstart) og effektivitet (patientresultater af AOD-brug og abstinenser) efter 12 måneder.
Modellen tager højde for intraklasse-korrelationerne på tværs af patienter inden for udbydere.
Omkostningseffektivitet i forhold til implementering og patientresultater vil blive undersøgt.
Barrierer og facilitatorer for implementering og gennemførlighed via kvalitative interviews med klinikere og administratorer vil også blive undersøgt.
Undersøgelsen er væsentlig, fordi den undersøger spørgsmål, der skal løses for at anspore til udbredt tilpasning af SBIRT.
De foreslåede interventioner er meget gennemførlige i det nuværende miljø med sundhedsreformer på grund af øgede ressourcer og uddannelse til føderalt kvalificerede sundhedscentre og private sundhedsplaner.
Det er innovativt i at bruge EMR til at ændre klinisk praksis og systematisk integrere AOD i pc og som en platform til indsamling af forskningsdata.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
9084
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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California
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Oakland, California, Forenede Stater, 94612
- Stacy A Sterling
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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
12 år til 80 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Der er to undersøgelsespopulationer som beskrevet nedenfor, således det store aldersgrænseområde.
Inklusionskriterier:
- Alle primære ungdomsplejere på den pædiatriske primære klinik vil blive inkluderet.
- Alle elektroniske journaler for unge patienter i alderen 12-18 år i den pædiatriske primære sygepleje vil blive undersøgt.
Ekskluderingskriterier:
- Alle primære udbydere af unge, der ikke praktiserer på den pædiatriske primære klinik, vil blive udelukket.
- Unge elektroniske journaler, som ikke er en del af forskningsstedets pædiatriske klinik, vil blive udelukket.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Primærlæge
Hvis den unge identificeres i risiko for stofbrug, foretages screeningen og den korte interventionshenvisning til den afgivne behandling af den primære læge.
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Screeningen, den korte intervention og henvisningen til behandling udføres af den primære læge
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Eksperimentel: Adfærdsmedicinsk specialist
Hvis den unge identificeres i risiko for stofbrug, screening og kort interventionshenvisning til behandling leveret af adfærdsmedicinsk specialist
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Screeningen, den korte intervention og henvisningen til behandling udføres af den adfærdsmedicinske specialist.
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Ingen indgriben: Sædvanlig pleje
Pleje udføres som normalt
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Screeningshastighed
Tidsramme: Indledende screeningsrate - ved indeksbrøndbesøg
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Andelen af patienter, der er screenet med Teen Well Check Questionnaire AOD-brug eller Humørsymptomspørgsmål, blandt alle patienter med Teen Well Check Questionnaire-besøg.
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Indledende screeningsrate - ved indeksbrøndbesøg
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Problemidentifikationshastighed
Tidsramme: Indledende problemidentifikationsrate - ved indeksbrøndbesøg, efter screening
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Andelen af screenede patienter, som svarer "ja" til AOD-brug eller humørsymptomer inden for de seneste 12 måneder og "ja" til mindst ét ikke-bil-CRAFFT-spørgsmål.
(At være i bil med nogen, der bruger AOD, hænger måske ikke sammen med barnets problem, men til at have en forælder/anden voksen, der har kørt, mens han har drukket/brugt).
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Indledende problemidentifikationsrate - ved indeksbrøndbesøg, efter screening
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Vurderingsprocent
Tidsramme: Inden for 2 uger efter indekset velbesøgsdato
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Andel af patienter, der screener positive for alkohol eller andre stoffer, eller mental sundhedsrisiko, som vurderes yderligere ved hjælp af CRAFFT-værktøjet.
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Inden for 2 uger efter indekset velbesøgsdato
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Kort interventionsrate
Tidsramme: Inden for 14 dage efter vurdering ved indeksbrøndbesøg
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Andelen af patienter, der modtager en intervention inden for 14 dage, blandt dem, der er identificeret med AOD-risiko (baseret på CRAFFT-score).
Dokumenteret i EPJ af klinikere, ved hjælp af en ICD-9 Administrativ V-kode til stofbrugsrådgivning eller adfærdsrådgivning.
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Inden for 14 dage efter vurdering ved indeksbrøndbesøg
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Henvisning til specialbehandlingstakst
Tidsramme: Inden for 6 måneder efter indeksvelbesøg
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Andelen af patienter, der modtager henvisninger til specialiseret adfærdsmæssig sundhedsbehandling, blandt dem, der gennem CRAFFT er identificeret som behov for en sådan behandling.
Dokumenteret i EPJ.
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Inden for 6 måneder efter indeksvelbesøg
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Indledning af special adfærdsmæssig sundhedsbehandling
Tidsramme: Inden for 2 år efter indgreb
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Defineret som den procentdel, der henvises til, som har mindst ét specialiseret adfærdssundhedsbesøg blandt dem, der er identificeret med et adfærdsmæssigt sundhedsproblem.
Dokumenteret i EPJ.
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Inden for 2 år efter indgreb
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Brug af alkohol og andre stoffer
Tidsramme: Brug inden for de seneste 6 måneder, 1 og 2 år efter indgrebet
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Alkohol- og stofbrug: Elementerne i EPJ måler sidste 30-dages og 6-måneders brug af alkohol, marihuana og andre stoffer og tobak, inklusive dages brug, forbrugt mængde (enhver, 3+ og 5+ drikkevarer) og dage af overspisning (3+ og 5+).
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Brug inden for de seneste 6 måneder, 1 og 2 år efter indgrebet
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Stofbrugsrelaterede udfald
Tidsramme: i de seneste 6 måneder, 1 og 2 år efter intervention
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AOD-relaterede juridiske, skole- og familieproblemer: EPJ-spørgsmålene inkluderer også foranstaltninger fra Comprehensive Adolescent Severity Inventory (CASI),148, et semi-struktureret spørgeskema, som måler unges sundhed og funktion på tværs af uddannelses-, juridiske og familiemæssige relationer.
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i de seneste 6 måneder, 1 og 2 år efter intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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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)
1. oktober 2011
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Anslået)
31. december 2025
Datoer for studieregistrering
Først indsendt
20. marts 2015
Først indsendt, der opfyldte QC-kriterier
31. marts 2015
Først opslået (Anslået)
6. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juli 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2023
Sidst verificeret
1. juli 2023
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