- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06182475
Erhöhung der Gerechtigkeit bei Lebendspende-Nierentransplantationen durch effektive Kommunikation zwischen Patient und Anbieter (EPPComm)
Das Ziel dieser klinischen Studie besteht darin, die Kommunikation zwischen schwarzen und kaukasischen Patienten und ihren Transplantationsanbietern während der Konsultationen zur Transplantationsbewertung zu verstehen und die Beziehungen zwischen diesen kommunikativen Elementen und Patienten- und Anbieterfaktoren, patientenberichteten Ergebnissen und Lebendspendertransplantationsergebnissen zu bewerten – Lebendspender Überweisungen, Bewertungen und Transplantationen. Wir werden diese Erkenntnisse nutzen, um die Entwicklung eines Kommunikationstrainings für Transplantationsanbieter zu unterstützen und die Auswirkungen des Trainings auf die Kommunikation der Anbieter über Lebendspende-Nierentransplantationen mit schwarzen und kaukasischen Patienten und die Ergebnisse von Lebendspender-Transplantationen zu testen.
Die wichtigsten Fragen, die beantwortet werden sollen, sind:
- Wie unterscheidet sich der Einsatz instrumenteller, relationaler und affektiver Kommunikation durch Patienten und Anbieter während der Transplantationsberatung je nach Patienten- und Anbieterfaktoren, vom Patienten berichteten Ergebnissen und der ethnischen Zugehörigkeit des Patienten?
- Welche Elemente der instrumentellen, relationalen und affektiven Kommunikation werden die Ergebnisse des Prozesses der Lebendspendernierentransplantation (LDKT) vorhersagen (LD-Anfragen und -Bewertungen sowie tatsächliche LDKTs)?
Die Teilnehmer werden gebeten, vor und nach der Transplantationskonsultation kurze Umfragen auszufüllen und der Audioaufzeichnung der Konsultation zuzustimmen.
Diese Daten werden verwendet, um eine Schulung zu entwickeln, um Anbieter über die wichtigsten Kommunikationsfaktoren aufzuklären, die die Ergebnisse des LDKT-Prozesses spezifisch für schwarze und kaukasische Patienten vorhersagen, und um Anleitungen für deren Anwendung bei Patientenkonsultationen bereitzustellen. Anschließend werden die Forscher die Ergebnisse der Kommunikation und der Patientenberichte sowie des LDKT-Prozesses zwischen geschulten und ungeschulten Anbietern vergleichen, um festzustellen, ob die Schulung Auswirkungen auf die Anfragen und Bewertungen von Lebendspendern sowie auf die tatsächlichen LDKTs hat.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Heather M Gardiner, PHD
- Telefonnummer: 215-204-3294
- E-Mail: heather.gardiner@temple.edu
Studieren Sie die Kontaktsicherung
- Name: Joie D Cooper, MS
- E-Mail: joie.cooper@temple.edu
Studienorte
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New Jersey
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Livingston, New Jersey, Vereinigte Staaten, 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, Vereinigte Staaten, 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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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- (1) zur Untersuchung einer Nierentransplantation im Cooperman Barnabas Medical Center (CBMC) oder im Temple University Hospital (TUH) erscheinen
- (2) Englisch sprechen
- (3) nach eigenen Angaben schwarzer oder kaukasischer Abstammung sein
- (4) mindestens 18 Jahre alt sein.
Einschließlich Patienten, die:
- bereits zuvor eine Nierentransplantation erhalten haben
- Patienten mit eingeschränkten Englischkenntnissen, sofern sie über einen Übersetzer mit dem Arzt sprechen
- Patienten, die an externen Satellitenstandorten untersucht wurden, die sich tatsächlich nicht am CBMC oder an der TUHS befinden.
Alle Transplantationsnephrologen, Krankenschwestern und Sozialarbeiter, die in den Nierentransplantationsprogrammen des CBMC und der TUH beschäftigt sind und aktiv an der Patientenbeurteilung für eine Transplantation beteiligt sind, können an der Studie teilnehmen. Anbieter, die sich weigern, die digitale Audioaufzeichnung der Transplantationsberatung zu gestatten, werden als nicht teilnahmeberechtigt erachtet.
Ausschlusskriterien:
- (1) nonverbal sind oder aus anderen Gründen nicht in der Lage sind, mit Anbietern zu kommunizieren
- (2) sind bereits für eine Nierentransplantation am CBMC oder TUHS oder einem anderen Transplantationszentrum gelistet
- (3) über begrenzte Englischkenntnisse verfügen und direkt mit dem Arzt in einer anderen Sprache als Englisch sprechen.
Patienten, die (1) von einem Familienmitglied oder Freund das Angebot erhalten haben, eine Niere zu spenden, oder (2) ein Familienmitglied oder einen Freund ausdrücklich gebeten haben, die Tätigkeit als LD in Betracht zu ziehen, werden ebenso ausgeschlossen wie alle Patienten, die sich weigern, digitale Audioaufzeichnungen zuzulassen Personen, die an der Transplantationssprechstunde teilnehmen, sind ebenfalls von der Teilnahme ausgeschlossen.
Die folgenden besonderen Bevölkerungsgruppen werden ausgeschlossen: Erwachsene, die nicht einwilligungsfähig sind, Personen, die noch nicht erwachsen sind (Säuglinge, Kinder, Jugendliche), Gefangene und Personen, die kein Englisch verstehen.
Es ist unwahrscheinlich, dass eine Patientin schwanger wird, während sie auf eine Nierentransplantation wartet. Wir werden jedoch schwangere Frauen nicht ausschließen.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: EPPCom-Anbieterschulung
Im Rahmen dieses Projekts wird ein äußerst ansprechendes und interaktives 60-minütiges persönliches Trainingsprogramm für Kommunikationsfähigkeiten entwickelt.
Teilnehmende Transplantationsanbieter führen vor (vor) und nach (nach) der Teilnahme an der Schulung eine kurze Online-Umfrage durch.
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Es wird ein Lehrplan entwickelt, um Patienten über LDKT aufzuklären und die Suche nach potenziellen Lebendspendern zu fördern und gleichzeitig die Werte und kulturellen Vorlieben der Patienten zu unterstützen.
Der Lehrplan besteht aus zwei Komponenten: didaktischer Ausbildung und kompetenzbasierter Kommunikation.
Die didaktische Komponente liefert Belege für die Auswirkungen der Patienten-Anbieter-Kommunikation und der LDKT-Prozessergebnisse für schwarze und kaukasische Patienten.
Die kompetenzbasierte Komponente wird das Kommunikationsvertrauen stärken und Diskussionen über LDKT leiten.
Es enthält Anweisungen für die wichtigsten Kommunikationsfähigkeiten, die erforderlich sind, um die Bedenken von Patienten bezüglich LDKT/Lebendspende souverän zu zerstreuen, und motiviert Patienten, nach einem Lebendspender zu suchen.
Folgendes wird behandelt: Bereitstellung von LDKT-Informationen/Beantwortung von Fragen, Hervorhebung der LDKT-Vorteile, Widerlegung von Fehlinformationen über Lebendspenden und Ermutigung von Patienten, nach Lebendspendern zu suchen.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Anfragen nach Lebendspendern
Zeitfenster: Bis zum Abschluss des Studiums 4 Jahre
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Ob potenzielle Spender ein ausgefülltes Spenderüberweisungsformular an das Transplantationsprogramm des Patienten zurücksenden (ja/nein)
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Bis zum Abschluss des Studiums 4 Jahre
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Live-Spenderbewertungen
Zeitfenster: Bis zum Abschluss des Studiums 4 Jahre
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Ob der potenzielle Spender persönlich zur Spenderbeurteilung erscheint (ja/nein)
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Bis zum Abschluss des Studiums 4 Jahre
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Nierentransplantation eines Lebendspenders
Zeitfenster: Bis zum Abschluss des Studiums 4 Jahre
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Ob der Patient eine Lebendspende-Nierentransplantation erhält (ja/nein)
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Bis zum Abschluss des Studiums 4 Jahre
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Francis Weng, MD, St. Barnabas Medical Center
Publikationen und hilfreiche Links
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Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Pathologische Prozesse
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Chronische Erkrankung
- Krankheitsattribute
- Niereninsuffizienz
- Pathologische Zustände, Anzeichen und Symptome
- Nierenversagen, chronisch
- Niereninsuffizienz, chronisch
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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