- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06182475
Øget retfærdighed i nyretransplantation af levende donorer gennem effektiv kommunikation mellem patient og udbyder (EPPComm)
Målet med dette kliniske forsøg er at forstå kommunikationen mellem sorte og kaukasiske patienter og deres transplantationsudbydere under transplantationsevalueringskonsultationer og vurdere forholdet mellem disse kommunikative elementer og patient- og udbyderfaktorer, patientrapporterede resultater og levende donortransplantationsresultater - levende donor henvisninger, evalueringer og transplantationer. Vi vil bruge disse resultater til at informere udviklingen af en træning i kommunikationsfærdigheder for transplantationsudbydere og teste effekten af træningen på udbyderes kommunikation om levende donor nyretransplantationer med sorte og kaukasiske patienter og levende donortransplantationsresultater.
De vigtigste spørgsmål, den sigter mod at besvare er:
- Hvordan adskiller brugen af brugen af instrumentel, relationel og affektiv kommunikation af patienter og udbydere under transplantationskonsultationen sig efter patient- og udbyderfaktorer, patientrapporterede resultater og patientetnicitet?
- Hvilke elementer af instrumentel, relationel og affektiv kommunikation vil forudsige resultaterne af levende donor nyretransplantation (LDKT) (LD-forespørgsler og -evalueringer og faktiske LDKT'er)?
Deltagerne vil blive bedt om at udfylde korte undersøgelser før og efter transplantationskonsultationen og give tilladelse til, at konsultationen kan lydoptages.
Disse data vil blive brugt til at udvikle en uddannelse til at uddanne udbydere i de vigtigste kommunikationsfaktorer, der forudsiger LDKT-procesresultater, der er specifikke for sorte og kaukasiske patienter, og give vejledning om deres anvendelse under patientkonsultationer. Forskere vil derefter sammenligne kommunikation og patientrapporterede og LDKT-procesresultater mellem trænede og utrænede udbydere for at se, om træningen har nogen effekt på levende donorforespørgsler og -evalueringer og faktiske LDKT'er.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Heather M Gardiner, PHD
- Telefonnummer: 215-204-3294
- E-mail: heather.gardiner@temple.edu
Undersøgelse Kontakt Backup
- Navn: Joie D Cooper, MS
- E-mail: joie.cooper@temple.edu
Studiesteder
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New Jersey
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Livingston, New Jersey, Forenede Stater, 07039
- Cooperman Barnabas Medical Center
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Kontakt:
- Francis Weng, MD
- Telefonnummer: 973-322-8216
- E-mail: Francis.Weng@rwjbh.org
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19122
- Temple University
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Kontakt:
- Heather M Gardiner (Traino), PhD, MPH
- Telefonnummer: 215-204-8330
- E-mail: heather.gardiner@temple.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- (1) møde op til en nyretransplantationsevaluering på Cooperman Barnabas Medical Center (CBMC) eller Temple University Hospital (TUH)
- (2) taler engelsk
- (3) være af selvrapporteret sort eller kaukasisk etnicitet
- (4) være ≥18 år gammel.
Herunder patienter, der:
- har modtaget tidligere nyretransplantationer
- patienter med begrænsede engelskkundskaber, så længe de taler med lægen via en oversætter
- patienter evalueret på offsite satellit-lokationer, som faktisk ikke er på CBMC eller TUHS.
Alle transplantationsnefrologer, sygeplejersker og socialrådgivere ansat ved nyretransplantationsprogrammerne på CBMC og TUH, som er aktivt involveret i patientevalueringer for transplantation, vil være berettiget til deltagelse i undersøgelsen. Udbydere, der nægter at tillade digital lydoptagelse af transplantationskonsultationen, vil blive betragtet som ikke-kvalificerede.
Ekskluderingskriterier:
- (1) er ikke-verbale eller på anden måde ude af stand til at tale med udbydere
- (2) er allerede opført til nyretransplantation på CBMC eller TUHS eller på et andet transplantationscenter
- (3) har begrænset engelskkundskab og taler direkte med lægen på et andet sprog end engelsk.
Patienter, der (1) har modtaget et tilbud om at donere en nyre fra et familiemedlem eller en ven, eller (2) eksplicit har bedt et familiemedlem eller en ven om at overveje at tjene som LD, vil blive udelukket, sammen med alle patienter, der nægter at tillade digital lydoptagelse af transplantationskonsultationen vil også blive anset for ikke at være berettiget til at deltage.
Følgende særlige populationer vil blive udelukket: voksne, der ikke kan give samtykke, personer, der endnu ikke er voksne (spædbørn, børn, teenagere), fanger og personer, der ikke forstår engelsk.
Det er usandsynligt, at nogen kvindelig patient vil være gravid, mens de venter på en nyretransplantation; vi vil dog ikke udelukke gravide.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: EPPCom Udbyderuddannelse
Et meget engagerende og interaktivt 60-minutters træningsprogram for personlig kommunikation vil blive udviklet som en del af dette projekt.
Deltagende transplantationsudbydere vil udfylde en kort online-undersøgelse før (før) og efter (efter) deltagelse i træningen.
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Der vil blive udviklet et pensum for at uddanne patienter om LDKT og fremme søgningen efter potentielle levende donorer og samtidig understøtte patienternes værdier og kulturelle præferencer.
Studieordningen vil bestå af to komponenter: didaktisk undervisning og færdighedsbaseret kommunikation.
Den didaktiske komponent giver bevis for virkningen af patient-leverandørkommunikation og LDKT-procesresultater for sorte og kaukasiske patienter.
Den færdighedsbaserede komponent vil opbygge kommunikationssikkerhed og lede diskussioner om LDKT.
Den giver instruktioner til de vigtigste kommunikationsfærdigheder, der er nødvendige for selvsikkert at lindre patienters bekymringer om LDKT/levende donation og motiverer patienter til at søge efter levende donor.
Følgende vil blive dækket: at give LDKT-information/besvare spørgsmål, fremhæve LDKT-fordele, tilbagevise forkert information om levende donationer og opmuntre patienter til at søge levende donorer.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Live donorforespørgsler
Tidsramme: Gennem studieafslutning, 4 år
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Om potentielle donorer returnerer en udfyldt donorhenvisningsformular til patientens transplantationsprogram (ja/nej)
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Gennem studieafslutning, 4 år
|
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Live donor evalueringer
Tidsramme: Gennem studieafslutning, 4 år
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Hvorvidt potentiel donor optræder personligt til donorevalueringen (ja/nej)
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Gennem studieafslutning, 4 år
|
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Levende donor nyretransplantation
Tidsramme: Gennem studieafslutning, 4 år
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Om patienten modtager en levende donor nyretransplantation (ja/nej)
|
Gennem studieafslutning, 4 år
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Francis Weng, MD, St. Barnabas Medical Center
Publikationer og nyttige links
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- Waterman AD, Robbins ML, Paiva AL, Peipert JD, Kynard-Amerson CS, Goalby CJ, Davis LA, Thein JL, Schenk EA, Baldwin KA, Skelton SL, Amoyal NR, Brick LA. Your Path to Transplant: a randomized controlled trial of a tailored computer education intervention to increase living donor kidney transplant. BMC Nephrol. 2014 Oct 14;15:166. doi: 10.1186/1471-2369-15-166.
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Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Nyreinsufficiens
- Patologiske tilstande, tegn og symptomer
- Nyresvigt, kronisk
- Nyreinsufficiens, kronisk
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