Screening op alcohol- en drugsgebruik door jongeren: een onderzoek onder eerstelijnszorgverleners
14 juli 2023 bijgewerkt door: Kaiser Permanente
Deze studie evalueert de implementatie en effectiviteit van twee modaliteiten van screening, korte interventie en verwijzing naar behandeling (SBIRT) om het gebruik van alcohol en andere drugs (AOD) door adolescenten in een grote kindergeneeskundekliniek te verminderen.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Gezondheidssystemen hebben Screening, Brief Intervention and Referral to Treatment (SBIRT) voor adolescenten niet geïmplementeerd, ondanks onderzoek dat de effectiviteit ervan aantoont.
Op basis van eerder onderzoek dat barrières identificeerde voor AOD-screening voor adolescenten in de pediatrische eerstelijnszorg (PC) en een pilotstudie waaruit bleek dat SBIRT haalbaar was, goed werd ontvangen en verwijzingen naar en het starten van gespecialiseerde behandeling bevorderde, stelt de huidige onderzoeksaanvraag voor om 45 Eerstelijnsartsen (PCP's) in de kindergeneeskundekliniek van een medisch centrum binnen een groot, beheerd zorgsysteem, Kaiser Permanente Noord-Californië, naar drie takken - 1) Gebruikelijke zorg; 2) SBIRT geleverd door PCP's; en 3) SBIRT geleverd door specialisten op het gebied van gedragsgeneeskunde (BMS).
Het doel van de studie is om de implementatie, effectiviteit en kosteneffectiviteit van SBIRT voor adolescenten in PC in de drie onderzoeksarmen te vergelijken.
Patiënten zullen op bewijzen gebaseerde screening en AOD-beoordelingsmaatregelen voltooien die zijn ingebed in het elektronische medische dossier (EMD) van het gezondheidsplan.
Er zal een gemengd model worden gebruikt om implementatieresultaten (percentages van screening en identificatie, korte interventie, verwijzing naar behandeling met chemische afhankelijkheid en start van de behandeling) en effectiviteit (patiëntresultaten van AOD-gebruik en onthouding) na 12 maanden te vergelijken.
Het model houdt rekening met de intra-klasse correlaties tussen patiënten binnen zorgverleners.
Kosteneffectiviteit ten opzichte van implementatie en patiëntuitkomsten zullen worden onderzocht.
Belemmeringen en facilitators van implementatie, en haalbaarheid via kwalitatieve interviews met clinici en bestuurders zullen ook worden onderzocht.
De studie is belangrijk omdat het problemen onderzoekt die moeten worden aangepakt om een wijdverspreide aanpassing van SBIRT aan te moedigen.
De voorgestelde interventies zijn zeer haalbaar in de huidige omgeving van gezondheidshervormingen dankzij meer middelen en training voor federaal gekwalificeerde gezondheidscentra en particuliere gezondheidsplannen.
Het is innovatief in het gebruik van de EMR om de klinische praktijk te veranderen en AOD systematisch te integreren in pc, en als een platform voor het verzamelen van onderzoeksgegevens.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
9084
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Oakland, California, Verenigde Staten, 94612
- Stacy A Sterling
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
12 jaar tot 80 jaar (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Er zijn twee onderzoekspopulaties zoals hieronder beschreven, dus het grote leeftijdsgrensbereik.
Inclusiecriteria:
- Alle adolescente eerstelijnszorgverleners in de pediatrische eerstelijnskliniek zullen worden opgenomen.
- Alle elektronische patiëntendossiers van adolescenten in de leeftijd van 12-18 jaar in de eerstelijns kindergeneeskunde zullen worden onderzocht.
Uitsluitingscriteria:
- Eerstelijnszorgverleners voor adolescenten die niet werkzaam zijn op de onderzoekslocatie van de pediatrische eerstelijnskliniek, worden uitgesloten.
- Elektronische dossiers van adolescenten die geen deel uitmaken van de pediatrische kliniek van de onderzoekslocatie worden uitgesloten.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Huisarts in de eerste lijn
Als wordt vastgesteld dat de adolescent risico loopt op middelengebruik, wordt de screening en de korte verwijzing naar de geleverde behandeling verzorgd door de huisarts
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De screening, korte interventie en verwijzing naar behandeling wordt verzorgd door de huisarts
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Experimenteel: Gedragsgeneeskundig specialist
Als de adolescent risico loopt op middelengebruik, de screening en korte interventie doorverwijzing naar behandeling door de gedragsgeneeskundig specialist
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De screening, korte interventie en verwijzing naar behandeling wordt verzorgd door de gedragsgeneeskundig specialist.
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Geen tussenkomst: Gebruikelijke zorg
De zorg wordt zoals gebruikelijk toegediend
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Screening tarief
Tijdsspanne: Initiële screening rate - bij index goed bezoek
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Het percentage patiënten dat wordt gescreend met de Teen Well Check Questionnaire AOD-gebruiks- of Stemmingssymptoomvragen, onder alle patiënten met Teen Well-kind-bezoeken.
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Initiële screening rate - bij index goed bezoek
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Probleem Identificatiegraad
Tijdsspanne: Eerste probleemidentificatiepercentage - bij indexbezoek, na screening
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Het percentage gescreende patiënten dat in de afgelopen 12 maanden "ja" antwoordde op AOD-gebruik of stemmingssymptomen en "ja" op ten minste één niet-auto-CRAFFT-vraag.
(In een auto zitten met iemand die AOD gebruikt, heeft misschien niet te maken met het probleem van het kind, maar met het hebben van een ouder/andere volwassene die onder invloed van alcohol heeft gereden).
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Eerste probleemidentificatiepercentage - bij indexbezoek, na screening
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Beoordelingspercentage
Tijdsspanne: Binnen 2 weken na indexeringsbezoekdatum
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Percentage patiënten dat positief screent op alcohol of andere drugs, of risico's voor de geestelijke gezondheid, dat verder wordt beoordeeld met behulp van de CRAFFT-tool.
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Binnen 2 weken na indexeringsbezoekdatum
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Kort interventietarief
Tijdsspanne: Binnen 14 dagen na beoordeling bij indexputbezoek
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Het aandeel patiënten dat binnen 14 dagen een interventie krijgt, onder degenen die zijn geïdentificeerd met AOD-risico (gebaseerd op CRAFFT-score).
Gedocumenteerd in EPD door clinici, met behulp van een ICD-9 Administratieve V-code voor begeleiding bij middelengebruik of gedragsbegeleiding.
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Binnen 14 dagen na beoordeling bij indexputbezoek
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Verwijzing naar gespecialiseerde behandeling tarief
Tijdsspanne: Binnen 6 maanden na index goed bezoek
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Het percentage patiënten dat wordt doorverwezen naar een gespecialiseerde gedragstherapie, onder degenen die via de CRAFFT zijn geïdentificeerd als een dergelijke behandeling nodig hebben.
Gedocumenteerd in het EPD.
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Binnen 6 maanden na index goed bezoek
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Initiatie van speciale gedragsgezondheidsbehandelingen
Tijdsspanne: Binnen 2 jaar na de interventie
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Gedefinieerd als het percentage verwezen, dat ten minste één speciaal bezoek heeft gehad op het gebied van gedragsgezondheid onder degenen die zijn geïdentificeerd met een gedragsgezondheidsprobleem.
Gedocumenteerd in het EPD.
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Binnen 2 jaar na de interventie
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Alcohol- en ander drugsgebruik
Tijdsspanne: Gebruik in de afgelopen 6 maanden, 1 en 2 jaar na de interventie
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Alcohol- en drugsgebruik: De items in het EPD meten het gebruik van alcohol, marihuana en andere drugs en tabak in de afgelopen 30 dagen en 6 maanden, inclusief dagen van gebruik, geconsumeerde hoeveelheid (alle, 3+ en 5+ drankjes) en dagen van binge drinken (3+ en 5+).
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Gebruik in de afgelopen 6 maanden, 1 en 2 jaar na de interventie
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Middelen Gebruiksgerelateerde uitkomsten
Tijdsspanne: in de afgelopen 6 maanden, 1 en 2 jaar na de interventie
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AOD-gerelateerde juridische, school- en gezinsproblemen: De EPD-vragen bevatten ook maatregelen uit de Comprehensive Adolescent Severity Inventory (CASI),148 een semi-gestructureerde vragenlijst die de gezondheid en het functioneren van adolescenten meet op het gebied van onderwijs, juridische zaken en gezinsrelaties.
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in de afgelopen 6 maanden, 1 en 2 jaar na de interventie
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2011
Primaire voltooiing (Werkelijk)
1 oktober 2013
Studie voltooiing (Geschat)
31 december 2025
Studieregistratiedata
Eerst ingediend
20 maart 2015
Eerst ingediend dat voldeed aan de QC-criteria
31 maart 2015
Eerst geplaatst (Geschat)
6 april 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 juli 2023
Laatste update ingediend die voldeed aan QC-criteria
14 juli 2023
Laatst geverifieerd
1 juli 2023
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11-07796
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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