- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04111939
HEALING Communities undersøgelse
HEALing Communities-undersøgelse: Udvikling og afprøvning af en integreret tilgang til at håndtere opioidkrisen
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40508
- University of Kentucky
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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New York
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New York, New York, Forenede Stater, 10027
- Columbia University
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Fællesskabet skal være placeret i en af de fire deltagende stater: Kentucky, Ohio, Massachusetts eller New York.
- Mindst 30 % af de udvalgte lokalsamfund i hver stat skal være landdistrikter.
- På tværs af alle HCS-samfundene i hver stat skal der være mindst 150 opioidrelaterede overdosisdødsfald (med mindst 22 opioidrelaterede overdosisdødsfald oplevet af landsamfundene) og en rate på mindst 25 opioidrelaterede overdosisdødsfald pr. 100.000 personer, baseret på 2016-data.
- Samfundet skal udtrykke vilje til i deres reaktionsstrategi at adressere implementeringen af MOUD, træning i forebyggelse af overdosis og distribution af naloxon på tværs af deres samfund.
- Samfundet skal udtrykke vilje til at udvikle partnerskaber på tværs af sundhedspleje, adfærdsmæssig sundhed og retfærdighedsindstillinger for evidensbaseret praksis til at håndtere opioidmisbrug, OUD og overdoser.
Ekskluderingskriterier:
- Fællesskaber, der ikke opfyldte de førnævnte inklusionskriterier, blev udelukket fra HCS.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Bølge 1 - Intervention
Fællesskaber i Wave 1 vil modtage CTH-interventionen i løbet af de første 30 måneder af forsøget.
Interventionen vil omfatte 3 komponenter: samfundsengagement for at hjælpe nøgleinteressenter med at anvende evidensbaseret praksis til at håndtere deres opioidkrise, en menu med evidensbaseret praksis, som lokalsamfund kan vælge og implementere, og en kommunikationskampagne for at opbygge efterspørgsel efter evidensbaseret praksis til at håndtere overdosis og opioidbrugsforstyrrelser.
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The Communities That HEAL (CTH) intervention er en samfundsengageret intervention designet til at øge adoptionen af et integreret sæt evidensbaserede praksisser leveret på tværs af sundhedspleje, adfærdsmæssig sundhed, retfærdighed og andre samfundsbaserede miljøer.
Det omfatter 3 komponenter: samfundsengagement for at hjælpe nøgleinteressenter med at anvende evidensbaseret praksis til at håndtere deres opioidkrise, en menu med evidensbaseret praksis, som lokalsamfund kan vælge og implementere, og en kommunikationskampagne for at skabe efterspørgsel efter evidensbaseret praksis til adressere overdosis og opioidbrugsforstyrrelser.
Andre navne:
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Andet: Wave 2 - Venteliste sammenligning
Fællesskaber i Wave 2 vil fortsætte med sædvanlig pleje i de første 30 måneder af forsøget.
Ved 31. måned begynder Wave 2-fællesskaber at modtage CTH-interventionen.
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Fællesskaber i ventelistekontroltilstanden vil fortsætte med sædvanlig pleje i de første 30 måneder af forsøget.
Ved 31. måned begynder Wave 2-fællesskaber at modtage CTH-interventionen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Antal dødsfald til overdosering af opioider
Tidsramme: Måneder 19-30
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Tælling af HCS Community Resident Overdosis dødsfald (dvs.
Dødsfald med en underliggende årsag til medikamentforgiftning), hvor opioider blev bestemt til at bidrage (alene eller i kombination med andre lægemidler) til lægemiddelforgiftningen.
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Måneder 19-30
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Antal naloxonenheder distribueret i samfund
Tidsramme: Måneder 19-30
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Tælling af naloxon -enheder, der er distribueret i HCS -samfundene i løbet af målingsperioden, som det blev fanget af følgende undervurderinger: 1) Tælling af naloxon -enheder, der er distribueret af statens sundhedsagentur (sekundære data fra statslige sundhedsagenturer) og HCS -undersøgelseslogfiler til Naloxone distribueret af undersøgelsen og 2) antallet af Naloxone -enheder, der er solgt af apoteker (iqvia apotekdata) data)
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Måneder 19-30
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Antal individer, der modtager buprenorphin -produkter, der er godkendt af Food and Drug Administration (FDA) til behandling af OUD
Tidsramme: Måneder 19-30
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Tælling af antallet af unikke individer, der modtager buprenorphin Moud i løbet af måleperioden.
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Måneder 19-30
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Hændelser med højrisiko-opioid-ordinering
Tidsramme: Måneder 19-30
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Tælling af personer med et eller flere af følgende i løbet af den tolv måneders studieperiode (måneder 19-30) og ikke i et forudgående specificeret tidsvindue (3 måneder): risiko for fortsat opioidbrug (ny opioidepisode, der varer mindst 31 dage); Initiering af opioidbehandling med udvidet frigivelse eller langtidsvirkende opioid; hændelse høj dosering (gennemsnit ≥ 90 mg morfin pr. Dag); og/eller hændelse overlappende opioid og benzodiazepin i ≥ 30 dage.
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Måneder 19-30
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Forekomst af bivirkninger pr. 1000 medlemmer af samfundet
Tidsramme: 44 måneder
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Den gennemsnitlige sats for Emergency Medical Service (EMS) kører for en mistænkt opioid overdosis pr. 1000 voksne for at vurdere potentielle bivirkninger og alvorlige bivirkninger i samfundet. Dette er data om samfundsniveau for EMS -kørsler (mistænkte overdoseringsbegivenheder i samfundet), men ikke dødsfald. Vi var nødt til at bruge en surrogatforanstaltning (EMS kører: ikke det samme som dødsfald, nogle kan være døde, men andre er måske blevet gemt) siden de decedente/dødsattestdata havde for lange af en forsinkelse. AE-kriterium: Oro (opioid-relateret overdosis) for en enkelt måned steg> 3 standardafvigelser (SDS) over den bevægende AVG i de foregående 3 måneder. SAE -kriterium: ORO -sats for en enkelt måned steg> 4 SDS over den bevægende AVG på de foregående 3 måneder. SD blev bestemt ud fra de månedlige satser for samfundene for den seneste tilgængelige 12-måneders periode før starten af interventionen ved hjælp af et samlet estimat på tværs af lokalsamfundene. Vi overvågede ikke på det individuelle deltagers niveau. |
44 måneder
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Young AM, Brown JL, Hunt T, Sprague Martinez LS, Chandler R, Oga E, Winhusen TJ, Baker T, Battaglia T, Bowers-Sword R, Button A, Fallin-Bennett A, Fanucchi L, Freeman P, Glasgow LM, Gulley J, Kendell C, Lofwall M, Lyons MS, Quinn M, Rapkin BD, Surratt HL, Walsh SL. Protocol for community-driven selection of strategies to implement evidence-based practices to reduce opioid overdoses in the HEALing Communities Study: a trial to evaluate a community-engaged intervention in Kentucky, Massachusetts, New York and Ohio. BMJ Open. 2022 Sep 19;12(9):e059328. doi: 10.1136/bmjopen-2021-059328.
- Tang X, Heeren T, Westgate PM, Feaster DJ, Fernandez SA, Vandergrift N, Cheng DM. Performance of model-based vs. permutation tests in the HEALing (Helping to End Addiction Long-termSM) Communities Study, a covariate-constrained cluster randomized trial. Trials. 2022 Sep 8;23(1):762. doi: 10.1186/s13063-022-06708-9.
- Walker DM, Childerhose JE, Chen S, Coovert N, Jackson RD, Kurien N, McAlearney AS, Volney J, Alford DP, Bosak J, Oyler DR, Stinson LK, Behrooz M, Christopher MC, Drainoni ML. Exploring perspectives on changing opioid prescribing practices: A qualitative study of community stakeholders in the HEALing Communities Study. Drug Alcohol Depend. 2022 Apr 1;233:109342. doi: 10.1016/j.drugalcdep.2022.109342. Epub 2022 Feb 2.
- Westgate PM, Cheng DM, Feaster DJ, Fernandez S, Shoben AB, Vandergrift N. Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model. Clin Trials. 2022 Apr;19(2):162-171. doi: 10.1177/17407745211063479. Epub 2022 Jan 6.
- Slavova S, LaRochelle MR, Root ED, Feaster DJ, Villani J, Knott CE, Talbert J, Mack A, Crane D, Bernson D, Booth A, Walsh SL. Operationalizing and selecting outcome measures for the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108328. doi: 10.1016/j.drugalcdep.2020.108328. Epub 2020 Oct 2.
- El-Bassel N, Jackson RD, Samet J, Walsh SL. Introduction to the special issue on the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108327. doi: 10.1016/j.drugalcdep.2020.108327. Epub 2020 Oct 1.
- Winhusen T, Walley A, Fanucchi LC, Hunt T, Lyons M, Lofwall M, Brown JL, Freeman PR, Nunes E, Beers D, Saitz R, Stambaugh L, Oga EA, Herron N, Baker T, Cook CD, Roberts MF, Alford DP, Starrels JL, Chandler RK. The Opioid-overdose Reduction Continuum of Care Approach (ORCCA): Evidence-based practices in the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108325. doi: 10.1016/j.drugalcdep.2020.108325. Epub 2020 Oct 4.
- Wu E, Villani J, Davis A, Fareed N, Harris DR, Huerta TR, LaRochelle MR, Miller CC, Oga EA. Community dashboards to support data-informed decision-making in the HEALing communities study. Drug Alcohol Depend. 2020 Dec 1;217:108331. doi: 10.1016/j.drugalcdep.2020.108331. Epub 2020 Oct 1.
- Sprague Martinez L, Rapkin BD, Young A, Freisthler B, Glasgow L, Hunt T, Salsberry PJ, Oga EA, Bennet-Fallin A, Plouck TJ, Drainoni ML, Freeman PR, Surratt H, Gulley J, Hamilton GA, Bowman P, Roeber CA, El-Bassel N, Battaglia T. Community engagement to implement evidence-based practices in the HEALing communities study. Drug Alcohol Depend. 2020 Dec 1;217:108326. doi: 10.1016/j.drugalcdep.2020.108326. Epub 2020 Oct 6.
- Walker DM, Shiu-Yee K, Chen S, DePuccio MJ, Jackson RD, McAlearney AS. Community Coalitions' Perspectives on Engaging with Hospitals in Ohio to Address the Opioid Crisis. Popul Health Manag. 2022 Dec;25(6):729-737. doi: 10.1089/pop.2022.0174. Epub 2022 Oct 28.
- Knudsen HK, Drainoni ML, Gilbert L, Huerta TR, Oser CB, Aldrich AM, Campbell ANC, Crable EL, Garner BR, Glasgow LM, Goddard-Eckrich D, Marks KR, McAlearney AS, Oga EA, Scalise AL, Walker DM. Model and approach for assessing implementation context and fidelity in the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108330. doi: 10.1016/j.drugalcdep.2020.108330. Epub 2020 Oct 2.
- Speer DD, Bush JL, Ekanayake DL, Nakayima J, Goetz MM, Miles J, Larimore E, Knudsen HK, Walsh SL, McCollister KE. Analysis of the costs and reach of transportation services to reduce barriers to opioid use disorder (OUD) treatment: evidence from the Kentucky HEALing Communities Study. Addict Sci Clin Pract. 2026 Jul 20. doi: 10.1186/s13722-026-00702-1. Online ahead of print.
- Goetz M, Andrews-Higgins S, Davis OA, Back-Haddix S, Fanucchi L, Lofwall MR, Walsh SL, Knudsen HK. Staff perceptions of care navigators in medication for opioid use disorder treatment settings. Subst Abuse Treat Prev Policy. 2026 Jun 27. doi: 10.1186/s13011-026-00743-4. Online ahead of print.
- Goddard-Eckrich D, Chahine RA, Glasgow L, Oga E, Miles J, Holloway J, Hall ME, Bagley SM, Kim E, Davis A, Chassler D, D'souza N, Mack S, Davis J, Harness J, Lea CH 3rd, Bridden C, Herron N, Larimore E, Calver K, Salsberry P. Community coalition's diversity and targeted overdose prevention strategies designed to reach special populations. Harm Reduct J. 2026 May 18. doi: 10.1186/s12954-026-01458-2. Online ahead of print.
- Walker DM, Aldrich AM, Chen S, Jadovich E, Goetz M, Andrews-Higgins S, Walley AY, Knudsen HK, Huerta TR, Hunt T, Drainoni ML. The role of external and internal context on adoption and implementation of evidence-based practices: a serial case study qualitative analysis of top performers in the HEALing Communities Study. Implement Sci Commun. 2026 Apr 25;7(1):115. doi: 10.1186/s43058-026-00952-9.
- Dsouza N, Russo M, Goddard-Eckrich D, Hernandez D, Sabounchi N, Lounsbury D, Fowler P, Benjamin SN, Campbell ANC, Dasgupta A, El-Bassel N, Gilbert L. Community-level perceptions of housing services for people with opioid use disorder: a qualitative analysis of community stakeholders in the HEALing communities study. Subst Abuse Treat Prev Policy. 2026 Apr 15;21(1):27. doi: 10.1186/s13011-025-00683-5.
- Speer DD, Bush JL, Ekanayake DL, Nakayima J, Goetz MM, Miles J, Larimore E, Knudsen HK, Walsh SL, McCollister KE. Analysis of the Costs and Reach of Transportation Services to Reduce Barriers to Opioid Use Disorder (OUD) Treatment: Evidence from the Kentucky HEALing Communities Study. Res Sq [Preprint]. 2025 Nov 20:rs.3.rs-7999770. doi: 10.21203/rs.3.rs-7999770/v1.
- Luster J, Reynolds J, Chahine R, Lewis N, Stein MD, Lefebvre RC, D'Costa L, Asman K, Stephens K, Dsouza N, Slater MD. A Cross-Sectional Study of Acceptability and Influence of HEALing Communities Study Communications Campaign Messaging Among Community Members in Four U.S. States. Am J Health Promot. 2026 Jul;40(6):654-662. doi: 10.1177/08901171251398985. Epub 2025 Nov 14.
- Li JM, Gruss D, Hunt T, David J, Rodgers E, El-Bassel N, Schackman BR, Starbird LE. Cost of implementing evidence-based practices to reduce opioid overdose fatalities in New York State communities. Addict Sci Clin Pract. 2025 Oct 1;20(1):77. doi: 10.1186/s13722-025-00606-6.
- Katz R, Fisher T, Singer-Clark T, Soares Iii W, Carpenter J, Schuessler N, Stadler H, Sahovey A, McAlearney AS, Samet JH, Chatterjee A. Creation of a telehealth addiction consultation service at a rural hospital: a case study. Addict Sci Clin Pract. 2025 Sep 26;20(1):76. doi: 10.1186/s13722-025-00596-5.
- Hall ME, Glasgow L, Holloway J, Chahine RA, Davis J, Harris MTH, Knudsen HK, Neufeld JL, Oga E, Lounsbury DW, Sabounchi N, Davis A, Smith M, Chase RP, Ellison SA, Harness J, Surratt HL, Walsh SL, Nakayima PJ, Chandler R. Reach of Community-Selected Strategies to Reduce Opioid-Related Overdose Deaths in the HEALing Communities Study. Subst Use Misuse. 2026;61(2):200-208. doi: 10.1080/10826084.2025.2549496. Epub 2025 Sep 2.
- Brown JL, Larochelle MR, Fanucchi LC, Calvert DC, Campbell ANC, Chandler RK, Feaster DJ, Glasgow LM, Gibson EB, Holloway J, Lofwall MR, Mack A, Mack N, Nunes EV, Talbert JC, Tan S, Vandergrift N, Villani J, Asman K, Babakhanlou-Chase H, Bagley SM, Battaglia TA, Blevins D, Bridden C, Cheng DM, Christopher M, Cogan LW, Cunningham CO, Eggleston B, Fareed N, Fernandez S, Freedman DA, Freiermuth CE, Freisthler B, Gilbert L, Hammerslag L, Harris D, Hunt T, Hussain S, Huynh P, Jackson RD, Kauffman EB, Knott C, Knudsen HK, Lefebvre RC, Levin FR, Massatti R, McAlearney AS, Morgan JR, Lopez RM, Lounsbury DW, Newman L, Nickels K, Oga EA, Oller DA, Parran TV, Quinn M, Ramsey KS, Rapkin BD, Salsberry P, Stein M, Taylor JL, Teater J, Walters ST, Zarkin GA, El-Bassel N, Winhusen TJ, Samet JH, Walsh SL. Effects of the Communities That HEAL intervention on initiation, retention, and linkage to medications for opioid use disorder (MOUD): A cluster randomized wait-list controlled trial. Drug Alcohol Depend. 2025 Sep 1;274:112785. doi: 10.1016/j.drugalcdep.2025.112785. Epub 2025 Jul 9.
- Sabounchi NS, Thompson RL, Lootens MR, Lounsbury DW, Hirsch G, Blevins D, Canty TC, El-Bassel N, Gilbert L, Mateu-Gelabert P, Feaster DJ, Rapkin BD, Huang TT. System dynamics modeling to inform implementation of evidence-based prevention of opioid overdose and fatality: A state-level model from the New York HEALing Communities Study. Int J Drug Policy. 2025 Aug;142:104843. doi: 10.1016/j.drugpo.2025.104843. Epub 2025 May 27.
- Gibson EB, Glasgow L, Nouvong M, McGladrey M, Freedman D, Chassler D, Vickers-Smith R, D'Onfro M, Goddard-Eckrich DA, Hunt T, Chatterjee A, Holloway J, Fain K, Cruz RS, Martinez LS. Implementing and documenting cultural adaption of evidence-based practice strategies to reduce opioid overdose deaths: examples and lessons from the HEALing communities study. Discov Public Health. 2025;22(1):296. doi: 10.1186/s12982-025-00696-2. Epub 2025 May 25.
- Silwal A, Bohler R, Hunt T, Olvera RG, Lofwall MR, Cook CD, Marks KR, Bridden C, Freeman PR, Nouvong M, Fanucchi LC, El-Bassel N, Frazier LA, Walsh SL, Talbert JC. Identifying and responding to policy-related barriers, facilitators, and misunderstandings in the HEALing communities study: A community-driven approach. Int J Drug Policy. 2025 Aug;142:104851. doi: 10.1016/j.drugpo.2025.104851. Epub 2025 May 22.
- Gilbert L, Chahine R, Chandler R, Feaster DJ, Kim E, Aldridge A, Bagley S, Balvanz P, Fernandez S, Rock P, Vickers-Smith RA, Villani J, Battaglia T, Brown J, Bush H, Chase RP, Collins T, D'Costa L, Damato-MacPherson C, David JL, Defiore-Hyrmer J, Freeman PR, Glasgow L, Hammerslag LR, Hotchkiss J, Hunt T, Hussain S, Kamanu V, Knott C, Knudsen HK, LaRochelle M, Laudate A, Lyons M, McMullan J, Nakayima J, Schackman BR, Slavova S, Tan S, Vandergrift N, Walters ST, Westgate PM, Wu E, Young AM, Zarkin GA, Freisthler B, Oga E, Samet JH, Walsh SL, Winhusen J, Jackson R, El-Bassel N. The effectiveness of the communities that HEAL intervention on reducing non-fatal opioid overdoses: A prespecified secondary analysis of a waitlist cluster control randomized controlled trial. Int J Drug Policy. 2025 Jun;140:104798. doi: 10.1016/j.drugpo.2025.104798. Epub 2025 Apr 11.
- Knudsen HK, Andrews-Higgins S, Back-Haddix S, Lofwall MR, Fanucchi L, Walsh SL. Barriers and facilitators to scaling up medications for opioid use disorder in Kentucky: qualitative perspectives of treatment organization staff. Subst Abuse Treat Prev Policy. 2025 Apr 2;20(1):15. doi: 10.1186/s13011-025-00644-y.
- Knudsen HK, Fallin-Bennett A, Fanucchi L, Lofwall MR, McGladrey M, Oser CB, Biggers G, Ross A, Chadwell J, Walsh SL. Increasing Initiation of Medications for Opioid Use Disorder Through Recovery Coaches: The Role of Implementation Setting. J Addict Med. 2026 Jan-Feb 01;20(1):15-21. doi: 10.1097/ADM.0000000000001482. Epub 2025 Mar 18.
- Knudsen HK, Back-Haddix S, Andrews-Higgins S, Goetz M, Davis OA, Oyler DR, Walsh SL, Freeman PR. Organizational perspectives on the impacts of scaling up overdose education and naloxone distribution in Kentucky. Addict Sci Clin Pract. 2025 Mar 14;20(1):27. doi: 10.1186/s13722-025-00553-2.
- Olvera RG, Cogan AG, Bartkus M, Benjamin SN, Davis J, Frazier LA, Henry BF, Hunt T, Kinnard EN, Mattingly H, McAlearney AS, Rivera D, Drainoni ML, Walker DM. Community coalitions' navigation of policies to address the opioid epidemic: insights from qualitative interviews in four states. BMJ Public Health. 2025 Feb 27;3(1):e001924. doi: 10.1136/bmjph-2024-001924. eCollection 2025.
- Knudsen HK, Andrews-Higgins S, Back-Haddix S, Lofwall MR, Fanucchi L, Walsh SL. Scaling up medications for opioid use disorder in Kentucky: Qualitative perspectives of treatment organizations. Res Sq [Preprint]. 2024 Dec 12:rs.3.rs-5440415. doi: 10.21203/rs.3.rs-5440415/v1.
- Sprunger J, Brown J, Rubi S, Papp J, Lyons M, Winhusen TJ. Jail-based interventions to reduce risk for opioid-related overdose deaths: Examples of implementation within Ohio counties participating in the HEALing Communities Study. Health Justice. 2024 Dec 5;12(1):48. doi: 10.1186/s40352-024-00307-3.
- Lewis N, Eggleston B, Chandler RK, Goddard-Eckrich D, Luster JE, Beard DD, Rodgers E, Chahine R, Westgate PM, Benjamin SN, Holloway J, Clarke T, Lefebvre RC, Stein MD, Helme DW, Reynolds J, Walsh SL, Freedman D, El-Bassel N, Stephens K, Silwal A, Lofwall M, Childerhose JE, Surratt HL, Crockett BN, Farmer AL, David JL, Fanucchi L, Harness J, Wilburn B, Bursey K, Mattson K, Mann S, Jackson RD, Shadwick A, Calver K, Chassler D, Kimball J, Regan N, Samet JH, Sword-Cruz R, Slater MD. Stigma and efficacy beliefs regarding opioid use disorder treatment and naloxone in communities participating in the HEALing Communities Study intervention. PLoS One. 2024 Dec 4;19(12):e0308965. doi: 10.1371/journal.pone.0308965. eCollection 2024.
- Freisthler B, Chahine RA, Villani J, Chandler R, Feaster DJ, Slavova S, Defiore-Hyrmer J, Walley AY, Kosakowski S, Aldridge A, Barbosa C, Bhatta S, Brancato C, Bridden C, Christopher M, Clarke T, David J, D'Costa L, Ewing I, Fernandez S, Gibson E, Gilbert L, Hall ME, Hargrove S, Hunt T, Kinnard EN, Larochelle L, Macoubray A, Nigam S, Nunes EV, Oser CB, Pagnano S, Rock P, Salsberry P, Shadwick A, Stopka TJ, Tan S, Taylor JL, Westgate PM, Wu E, Zarkin GA, Walsh SL, El-Bassel N, Winhusen TJ, Samet JH, Oga EA. Communities That HEAL Intervention and Mortality Including Polysubstance Overdose Deaths: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2440006. doi: 10.1001/jamanetworkopen.2024.40006.
- Freeman PR, Walley AY, Winhusen TJ, Oga EA, Villani J, Hunt T, Chandler RK, Oyler DR, Reilly B, Gelberg K, Douglas C, Lyons MS, Holloway J, Vandergrift NA, Adams JW, Asman K, Baker TJ, Brancato CJ, Cheng DM, Childerhose JE, David JL, Feaster DJ, Gilbert L, Glasgow LM, Goddard-Eckrich DA, Knott C, Knudsen HK, Lofwall MR, Marks KR, McMullan JT, Oser CB, Roberts MF, Shoben AB, Stein MD, Walters ST, Watson J, Zarkin GA, Jackson RD, Samet JH, Walsh SL, Bassel NE. Effect of the Communities That HEAL Intervention on Overdose Education and Naloxone Distribution: A Cluster-Randomized, Wait-List Controlled Trial. Am J Public Health. 2025 Jan;115(1):83-94. doi: 10.2105/AJPH.2024.307845. Epub 2024 Oct 10.
- Fareed N, Olvera RG, Wang Y, Hayes M, Larimore EL, Balvanz P, Langley R, Noel CA, Rock P, Redmond D, Neufeld J, Kosakowski S, Harris D, LaRochelle M, Huerta TR, Glasgow L, Oga E, Villani J, Wu E. Lessons Learned From Developing Dashboards to Support Decision-Making for Community Opioid Response by Community Stakeholders: Mixed Methods and Multisite Study. JMIR Hum Factors. 2024 Sep 9;11:e51525. doi: 10.2196/51525.
- Christine PJ, Chahine RA, Kimmel SD, Mack N, Douglas C, Stopka TJ, Calver K, Fanucchi LC, Slavova S, Lofwall M, Feaster DJ, Lyons M, Ezell J, Larochelle MR. Buprenorphine Prescribing Characteristics Following Relaxation of X-Waiver Training Requirements. JAMA Netw Open. 2024 Aug 1;7(8):e2425999. doi: 10.1001/jamanetworkopen.2024.25999.
- Olvera RG, Plagens C, Ellison S, Klingler K, Kuntz AK, Chase RP. Community-Engaged Data Science (CEDS): A Case Study of Working with Communities to Use Data to Inform Change. J Community Health. 2024 Dec;49(6):1062-1072. doi: 10.1007/s10900-024-01377-y. Epub 2024 Jul 3.
- Oser CB, McGladrey M, Booty M, Surratt H, Knudsen HK, Freeman PR, Stevens-Watkins D, Roberts MF, Staton M, Young A, Draper E, Walsh SL. Rapid jail-based implementation of overdose education and naloxone distribution in response to the COVID-19 pandemic. Health Justice. 2024 Jun 27;12(1):27. doi: 10.1186/s40352-024-00283-8.
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- Glasgow L, Douglas C, Sprunger JG, Campbell ANC, Chandler R, Dasgupta A, Holloway J, Marks KR, Roberts SM, Martinez LS, Thompson K, Weiss RD, Aldridge A, Asman K, Barbosa C, Blevins D, Chassler D, Cogan L, Fanucchi L, Hall ME, Hunt T, Jadovich E, Levin FR, Lincourt P, Lofwall MR, Loukas V, McAlearney AS, Nunes E, Oga E, Oller D, Rudorf M, Sullivan AM, Talbert J, Taylor A, Teater J, Vandergrift N, Woodlock K, Zarkin GA, Freisthler B, Samet JH, Walsh SL, El-Bassel N. Effect of the Communities that HEAL intervention on receipt of behavioral therapies for opioid use disorder: A cluster randomized wait-list controlled trial. Drug Alcohol Depend. 2024 Jun 1;259:111286. doi: 10.1016/j.drugalcdep.2024.111286. Epub 2024 Apr 5.
- Montoya ID, Watson C, Aldridge A, Ryan D, Murphy SM, Amuchi B, McCollister KE, Schackman BR, Bush JL, Speer D, Harlow K, Orme S, Zarkin GA, Castry M, Seiber EE, Barocas JA, Linas BP, Starbird LE. Cost of start-up activities to implement a community-level opioid overdose reduction intervention in the HEALing Communities Study. Addict Sci Clin Pract. 2024 Apr 2;19(1):23. doi: 10.1186/s13722-024-00454-w.
- Moffitt T, Fallin-Bennett A, Fanucchi L, Walsh SL, Cook C, Oller D, Ross A, Gallivan M, Lauckner J, Byard J, Wheeler-Crum P, Lofwall MR. The development of a recovery coaching training curriculum to facilitate linkage to and increase retention on medications for opioid use disorder. Front Public Health. 2024 Feb 15;12:1334850. doi: 10.3389/fpubh.2024.1334850. eCollection 2024.
- Stopka TJ, Babineau DC, Gibson EB, Knott CE, Cheng DM, Villani J, Wai JM, Blevins D, David JL, Goddard-Eckrich DA, Lofwall MR, Massatti R, DeFiore-Hyrmer J, Lyons MS, Fanucchi LC, Harris DR, Talbert J, Hammerslag L, Oller D, Balise RR, Feaster DJ, Soares W, Zarkin GA, Glasgow L, Oga E, McCarthy J, D'Costa L, Chahine R, Gomori S, Dalvi N, Shrestha S, Garner C, Shadwick A, Salsberry P, Konstan MW, Freisthler B, Winhusen J, El-Bassel N, Samet JH, Walsh SL. Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e240132. doi: 10.1001/jamanetworkopen.2024.0132.
- Rock P, Slavova S, Westgate PM, Nakamura A, Walsh SL. Examination of naloxone dosing patterns for opioid overdose by emergency medical services in Kentucky during increased fentanyl use from 2018 to 2021. Drug Alcohol Depend. 2024 Feb 1;255:111062. doi: 10.1016/j.drugalcdep.2023.111062. Epub 2023 Dec 14.
- McGladrey M, Kelsch J, Lofwall MR, Fanucchi LC, Walsh SL, Oser CB. Get It in Writing: How to Make Medications for Opioid Use Disorder Available During Incarceration. J Correct Health Care. 2024 Feb;30(1):3-6. doi: 10.1089/jchc.23.08.0065. Epub 2023 Dec 26.
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- Chatterjee A, Baker T, Rudorf M, Walt G, Stotz C, Martin A, Kinnard EN, McAlearney AS, Bosak J, Medley B, Pinkhover A, Taylor JL, Samet JH, Lunze K. Mobile treatment for opioid use disorder: Implementation of community-based, same-day medication access interventions. J Subst Use Addict Treat. 2024 Apr;159:209272. doi: 10.1016/j.josat.2023.209272. Epub 2023 Dec 19.
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Andre undersøgelses-id-numre
- 38088
- 1UM1DA049394 (U.S. NIH-bevilling/kontrakt)
- 1UM1DA049415 (U.S. NIH-bevilling/kontrakt)
- 1UM1DA049417 (U.S. NIH-bevilling/kontrakt)
- 1UM1DA049412 (U.S. NIH-bevilling/kontrakt)
- 1UM1DA049406 (U.S. NIH-bevilling/kontrakt)
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IPD-planbeskrivelse
Vi planlægger at gøre undersøgelsesmetoder, data og resultater tilgængelige for alle, der er interesserede i at reducere byrden af opioidkrisen. Datadelingsplanen vil overholde NIH HEAL Initiative ClinicalTrials.govSM Politik for offentlig adgang og datadeling, NIH's datadelingspolitik og NIH-politikken om formidling af NIH-finansierede oplysninger om kliniske forsøg og reglen om indsendelse af oplysninger om kliniske forsøg i NIH.
Datadelingsplanen vil følge NIHs krav til deling af data via oprettelse af datasæt til offentlig brug. En struktureret proces vil blive brugt til at evaluere risikoen for re-identifikation baseret på vejledningsdokumenter fra det amerikanske DHHS og HIPAA. Risikoen for re-identifikation vil også blive vurderet kvantitativt ved brug af anerkendte statistiske metoder. Undersøgelsesdata deponeret i et depot udvalgt af NIDA, såsom National Addiction & HIV Data Archive Program, vil blive afidentificeret eller maskeret for at minimere risici for at studere deltagernes privatliv.
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