- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07528846
Justice Community Overdose Innovation Network II TCU Hub (JCOIN II TCU)
7. april 2026 opdateret af: Jennifer Becan, Texas Christian University
Justice Community Overdose Innovation Network II TCU Hub: TCU Building Resilient Initiatives for Deflection Through Greater Engagement Project (TCU BRIDGE to Deflection Project)
Det nuværende studie foreslår at bruge en Hybrid Type 3 implementeringsforskningsstrategi til: 1) Betydeligt at forbedre vores forståelse af folkesundhedsresultater [f.eks. overdoser og stofbrugsrelaterede (SU) kontakter med Akutmedicinsk Tjeneste (EMS)] og offentlige sikkerhedsresultater (f.eks. narkotikarelaterede anholdelser) forbundet med Aflednings- og Før-Anholdelse-Omledningsinitiativer (DPAD, herefter omtalt som Afledning); og 2) Skabe et varigt bidrag til forskningsområderne fokuseret på SU og det kriminelle retssystem (CLS) ved at udvide viden om effektive implementeringsstrategier, der involverer det afgørende samfundsengagement i Afledning.
Det meget erfarne team af Multiple PIs, seniorniveau-samarbejdspartnere fra både Afledning og Community Behavioral Health (CBH), evalueringspartnere på statsniveau, en national interessentrådgivningsgruppe og CLS- og adfærdsmæssige sundhedspartnere i hvert samfund har slået sig sammen for at gennemføre det foreslåede projekt.
Studietilgangen bruger en hybrid implementeringseffektivitetsdesign til at undersøge strategier for at forbedre opioid- og stimulantrelevante resultater og foreslår specifikt at teste implementeringseffektiviteten af 2 strategipakker for at fremme Afledningsmodeller gennem en CORE samfundsengagementspakke (designet til at lette interessentengagement i samfundet) og ENHANCED samfundsengagementspakke (CORE plus en komponent til systematisk at involvere samfundsfortalere) på at forbedre implementering såvel som offentlige sikkerheds- og sundhedsresultater.
Det foreslåede randomiserede kontrolforsøg omfatter i alt 20 geografisk forskellige kliniske forskningsudførelsessteder (dvs. 20 samfund spredt over 5 stater; New Mexico, Illinois, Wisconsin, Colorado og Pennsylvania), med 3-5 samfund per stat og inklusionen af centrale CLS- og CBH-interessenter på hvert sted.
Projektets store omfang vil maksimere den potentielle generaliserbarhed af studieresultater og bæredygtigheden af implementeringsstrategier.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1620
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Amanda W Sease, Ph.D.
- Telefonnummer: 817-257-5841
- E-mail: a.wiese@tcu.edu
Studiesteder
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Texas
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Fort Worth, Texas, Forenede Stater, 76109
- Texas Christian University
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Personale
Inklusionskriterier:
- Direkte involveret i Deflection-tjenester, inklusive:
- Foretage henvisninger (f.eks. politi, førstehjælpere, samfundsorganisationer) & Yde tjenester til deltagere (f.eks. casemanagere, peer-specialister, koordinatorer);
- 18 år eller ældre;
- I stand til at udfylde spørgeskemaer på engelsk;
- Villig til at give informeret samtykke
Eksklusionskriterier:
- Ikke tilknyttet en deltagende Deflection-agentur;
- Ingen rolle i Deflection-henvisning eller serviceydelse;
- Under 18 år;
- Ikke i stand eller uvillig til at give informeret samtykke
Klienter
Inklusionskriterier:
- 18 år eller ældre;
- Indskrevet i et Deflection-program i et deltagende samfund;
- Mellem 1 og 12 måneder efter indskrivning på rekrutteringstidspunktet;
- Dokumenteret historie med stofmisbrugsforstyrrelse (SUD) eller risiko for SUD;
- Prioritet for personer, der rapporterer opioid- og/eller stimulansbrug inden for det seneste år;
- I stand til at udfylde spørgeskema og/eller interview; Villig til at give informeret samtykke
Eksklusionskriterier:
- Under 18 år;
- Ikke indskrevet i et Deflection-program;
- Utilstrækkelig eksponering for Deflection (<1 måned);
- Ikke i stand eller uvillig til at give informeret samtykke
Borgere
Inklusionskriterier:
- 18 år eller ældre;
- Beboer i et deltagende samfund;
- Repræsenterer den generelle befolkning (inklusive personer med eller uden erfaring med SUD/CLS-involvering);
- I stand til at deltage i: Spørgeskemaer og/eller Community Listening Sessions;
- Villig til at give informeret samtykke
Eksklusionskriterier:
- Under 18 år;
- Bør ikke bo i et deltagende samfund;
- Ikke i stand eller uvillig til at give informeret samtykke
Arbejdsgruppe
Inklusionskriterier:
- 18 år eller ældre;
- Identificeret som en samfunds- eller agenturleder/stakeholder involveret i Deflection-programmering;
- Medlem af en DAG i et deltagende samfund;
- Repræsenterer en af de påkrævede stakeholder-roller: Politiets ledelse eller personale, Adfærdsmæssig sundhedsledelse eller personale Sundhedsfaglig, Samfundsrepræsentant (borger);
- I stand til at deltage i møder, spørgeskemaer og/eller fokusgrupper;
- Villig til at give informeret samtykke
Eksklusionskriterier:
- Ikke en del af en DAG i et deltagende samfund;
- Har ikke en rolle relevant for Deflection-ledelse eller beslutningstagning;
- Under 18 år;
- Ikke i stand eller uvillig til at give informeret samtykke
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Kernegruppe-samarbejde om samfundsengagement
faciliterede samarbejde på tværs af myndigheder inden for folkesundhed og offentlig sikkerhed, bedste praksis for at opbygge samfundsengagement og tværgående data-drevet læring
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fællesskabsengagementsmetoder, der inkluderer opbygning af tvarorganisatorisk samarbejde, strategisk planlægning, talsmandsskab
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Andet: Forbedret-Kerne plus fællesskabsengagementsspecialist
kerne plus strategisk rolleudvikling og coaching af kendte og betroede borgere til at fungere som Samfundsfortalere i fremme af samfundets støtte til afledningsindsatser og fuldt ud deltage i afledningsledelsesbeslutninger
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community engagement-tilgange, der inkluderer kernen, plus at fremme identifikation og fuld integration af lokalsamfundsborgere i community engagement-praksisser
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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samarbejde om folkesundhed og sikkerhed
Tidsramme: Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
|
Er der en ændring i samarbejdet om folkesundhed og sikkerhed?
Målt ved hjælp af Brewer et al., 2018-undersøgelsen om at justere strategi (f.eks. arbejde sammen for at identificere uopfyldte behov i samfundet) og koordinere nuværende arbejde (f.eks. dele information, der hjælper plejesystemet med at fungere bedre).
Brewer et al. (2018)-undersøgelsen om at justere strategi og koordinere arbejde måles på en 5-punkts Likert-skala, og scorer beregnes ved at gennemsnitlige alle elementer inden for hver skala for at give et middelværdi.
Højere scorer = stærkere samarbejde / justering / koordinering
|
Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
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borgernes bevidsthed og opfattede nytteværdi af Deflection
Tidsramme: Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
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Er der en ændring i borgeres bevidsthed og opfattet nytte af Afbøjning?
Målt ved hjælp af flere spørgeskemaer om holdninger til afbøjningsindsatser og retshåndhævelse i deres lokalsamfund, herunder bevidsthed, acceptabilitet, hensigtsmæssighed og gennemførlighed.
Spørgeskemamålinger scores ved at sammenligne skalaemner for at opnå et gennemsnit, hvor højere score indikerer højere niveauer af bevidsthed, acceptabilitet, hensigtsmæssighed og gennemførlighed.
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Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
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afledningsarbejdsstyrkens henvisninger og borgerindmeldelser i Afledning
Tidsramme: Måned 10, 26 og 38 for Wave1; Måned 14, 30 og 42 for Wave 2
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Er der en ændring i arbejdsstyrkereferater og borgerindskrivninger i Deflection?
Målt ved hjælp af eksisterende data indsamlet af deflection-programmet om henvisninger og indskrivninger til deflection-tjenester, herunder adoption (f.eks. andel af arbejdsstyrken og agenturer, der henviser klienter til deflection), penetration (f.eks. antal deflection-henvisninger og -indskrivninger), lighed (f.eks. andel af henvisninger og indskrivninger med minoritetsrepræsentation) og opretholdelse (f.eks. fortsat adoption og penetration).
Score for hver vil blive repræsenteret af et antal/nummer.
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Måned 10, 26 og 38 for Wave1; Måned 14, 30 og 42 for Wave 2
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overdosis og stofmisbrugsrelateret dødelighed
Tidsramme: Måned 4-38 for Bølge 1; Måned 8-42 for Bølge 2
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Er der en ændring i overdosis- og SU-relaterede dødsrater?
Målt ved hjælp af National Association of State EMS Officials (NAEMSSO) harmoniserede data, som indsamles fra EMS-organisationer i de 5 deltagende stater, samt gennem retsmedicinske/vitalstatistikregistre over dødsårsagsoplysninger for lokalsamfundene.
Raterne repræsenteres af et antal/tal for overdoser og SU-relaterede dødsrater, før og efter implementering.
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Måned 4-38 for Bølge 1; Måned 8-42 for Bølge 2
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serviceadgang langs hele det fulde stofbrugskaskade
Tidsramme: Måned 4-38 for Bølge 1; Måned 8-42 for Bølge 2
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Er der en ændring i adgangen til service langs hele stofbrugskaskaden og komplekse behov?
Målt gennem datadeling af eksisterende optegnelser fra afbøjningsprogrammer.
Tal/antal vil blive brugt til at måle hvert trin i stofbrugskaskaden.
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Måned 4-38 for Bølge 1; Måned 8-42 for Bølge 2
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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afbøjning arbejdsstyrke holdninger over for afbøjning
Tidsramme: Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
|
Er der en ændring i politiets holdninger til afledning?
Målt ved hjælp af Donnelly et al. (2024) Tough on Crime Index og Bailey et al. (2024) Stigma and Policing Attitudes Toward PWUD Scale, vurderes emner på Likert-skalaer og beregnes gennemsnit for at skabe sammensatte scores, hvor højere værdier indikerer en stærkere tilslutning til straffende ("tough on crime") holdninger og større stigma over for personer, der bruger stoffer, og restriktive polititiltag.
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Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
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borgeres vurderinger af tilliden til samfundets lovhåndhævelse
Tidsramme: Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
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Er der en ændring i tilliden mellem samfund og lovhåndhævelse?
Målt ved hjælp af Hamm et al. (2018) Community-Law Enforcement Trust Scale, vurderes punkterne på Likert-type skalaer og gennemsnitsberegnes for at skabe en sammensat score, hvor højere værdier indikerer større opfattet tillid mellem samfundsmedlemmer og lovhåndhævelse.
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Måned 10, 26 og 38 for Bølge 1; Måned 14, 30 og 42 for Bølge 2
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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 E Becan, Ph.D., Texas Christian University
- Ledende efterforsker: Kevin Knight, Ph.D., Texas Christian University
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.
Generelle publikationer
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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 (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. marts 2029
Studieafslutning (Anslået)
1. maj 2029
Datoer for studieregistrering
Først indsendt
30. marts 2026
Først indsendt, der opfyldte QC-kriterier
7. april 2026
Først opslået (Faktiske)
14. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. april 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. april 2026
Sidst verificeret
1. april 2026
Mere information
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Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1RM1DA064502 (U.S. NIH-bevilling/kontrakt)
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