- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01621711
Fortsatt vård efter drogmissbruksbehandling: koppling till primärvård (Linkage)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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California
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San Francisco, California, Förenta staterna, 94115
- Kaiser Permanente, Chemical Dependency Recovery Program
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Forskningsdeltagare kommer att vara vuxna patienter vid Kaiser Permanente San Francisco Chemical Dependency Recovery Program, som har genomgått 2 veckors behandling.
Exklusions kriterier:
- Patienter med diagnosen demens, mental retardation eller som är aktivt psykotiska eller suicidala kommer att uteslutas av sin läkare.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Vanlig vård
Vanlig CD-behandling, inklusive terapigrupper och individuella rådgivningssessioner, och sex 45-minuters medicinska utbildningsgrupper.
Läkarbesök, farmakoterapi och SUD-mediciner var tillgängliga vid behov.
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Experimentell: Koppla patientaktiveringsintervention
Vanlig vård med undantaget att de sex 45-minuters kopplingsgrupperna för patientaktivering ersatte de sex 45-minuters läkarutbildningsgrupperna i 45 min, plus ett kopplingstelefonsamtal (och/eller ett underlättat e-postmeddelande) med patienten, läkaren och primärvården läkare.
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Usual Care plus Linkage omfattade Usual Care med undantaget att de sex 45-minuters Linkage-patientaktiveringsutbildningsgrupperna ersatte de sex 45-minutersmedicinska utbildningsgrupperna för Usual Care, plus ett länksamtal (och/eller ett förenklat e-postmeddelande) med patienten, läkare och primärvårdsläkare. Patientaktiveringsinterventionskomponenterna - 1) sex 45-minuters kopplingssessioner om aktivering angående övergripande hälsobeteenden och 2) ett kopplingstelefonsamtal (och/eller ett underlättat e-postmeddelande) med patienten, läkaren och PC-läkaren - levererades av en klinisk psykolog. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
patientaktiveringsåtgärd
Tidsram: 6 månader efter baslinjen
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Mäts med Patient Activation Measure (PAM) från intervjudata
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6 månader efter baslinjen
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patientens engagemang i hälso- och sjukvården (inklusive patientportalanvändning, förtrogenhet och tillfredsställelse med primärvårdsläkare och CD-behandlingslängd på vistelsen)
Tidsram: 6 månader efter baslinjen
|
Mätt med data från intervjuer och elektronisk journal (EPJ)
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6 månader efter baslinjen
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Missbruk och psykisk hälsa
Tidsram: 6 månader efter baslinjen
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Åtgärder inkluderar tidigare 30 dagars alkohol, droger och total abstinens; Patient Health Questionnaire (PHQ-9) och Addiction Severity Index med hjälp av intervjudata
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6 månader efter baslinjen
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
patientaktiveringsåtgärd vid 12 och 24 månader
Tidsram: 12 och 24 månader efter baslinjen
|
Mäts med Patient Activation Measure (PAM) från intervjudata
|
12 och 24 månader efter baslinjen
|
patientengagemang i vården vid 12 och 24 månader
Tidsram: 12 och 24 månader efter baslinjen
|
Mätt med data från intervjuer och elektronisk journal (EPJ)
|
12 och 24 månader efter baslinjen
|
Missbruk och psykisk hälsa vid 12 och 24 månader
Tidsram: 12 och 24 månader efter baslinjen
|
Åtgärder inkluderar tidigare 30 dagars alkohol, droger och total abstinens; Patient Health Questionnaire (PHQ-9) och Addiction Severity Index med hjälp av intervjudata
|
12 och 24 månader efter baslinjen
|
Hälsovårdens utnyttjande och kostnad
Tidsram: 12 och 24 månader efter baslinjen
|
Mätt med data från intervjuer och administrativa data
|
12 och 24 månader efter baslinjen
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Constance M Weisner, DrPH, LCSW, Kaiser Permanente
Publikationer och användbara länkar
Allmänna publikationer
- Willems S, De Maesschalck S, Deveugele M, Derese A, De Maeseneer J. Socio-economic status of the patient and doctor-patient communication: does it make a difference? Patient Educ Couns. 2005 Feb;56(2):139-46. doi: 10.1016/j.pec.2004.02.011.
- Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
- Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.
- Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Sterling S, Chi F, Campbell C, Weisner C. Three-year chemical dependency and mental health treatment outcomes among adolescents: the role of continuing care. Alcohol Clin Exp Res. 2009 Aug;33(8):1417-29. doi: 10.1111/j.1530-0277.2009.00972.x. Epub 2009 Apr 30.
- Mertens JR, Lu YW, Parthasarathy S, Moore C, Weisner CM. Medical and psychiatric conditions of alcohol and drug treatment patients in an HMO: comparison with matched controls. Arch Intern Med. 2003 Nov 10;163(20):2511-7. doi: 10.1001/archinte.163.20.2511.
- Weisner C, Mertens J, Parthasarathy S, Moore C, Lu Y. Integrating primary medical care with addiction treatment: a randomized controlled trial. JAMA. 2001 Oct 10;286(14):1715-23. doi: 10.1001/jama.286.14.1715.
- Parthasarathy S, Weisner CM. Five-year trajectories of health care utilization and cost in a drug and alcohol treatment sample. Drug Alcohol Depend. 2005 Nov 1;80(2):231-40. doi: 10.1016/j.drugalcdep.2005.04.004.
- Mertens JR, Flisher AJ, Satre DD, Weisner CM. The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20.
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