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Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation

11. januar 2021 opdateret af: University of North Carolina, Chapel Hill

Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation: a Pilot Study

More than 80% of individuals in the U.S. start maintenance hemodialysis (HD) with a central venous catheter, despite substantial evidence that starting HD with an arteriovenous (AV) access improves quality of life, lowers mortality, and decreases healthcare costs. Health system- and patient-level barriers contribute to low rates of AV access creation prior to HD initiation. Evidence-based, pre-dialysis interventions to improve these low rates and associated clinical outcomes are lacking.

A Vascular Access Navigation and Education Quality Improvement Program will be implemented in the Geisinger Danville, PA chronic kidney disease clinic. Individuals who choose to participate in a research sub-study of the program will complete questionnaires to assess their vascular access care knowledge and confidence before and after participation in the quality improvement program.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

46

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Danville Nephrology Clinic

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Patients:

  • Receive care at the Geisinger Danville Nephrology Clinic
  • Age ≥ 18 years
  • eGFR ≤ 25 mL/min/1.73 m and 2-year kidney failure risk score >10% based on kidney failure risk equation, or nephrologist recommendation for vascular access
  • Participation in the Vascular Access Navigation and Education Quality Improvement Program

Providers: Professional involved in dialysis vascular access care (e.g., nephrologist, surgeon, kidney disease clinic nurse, etc.) at Geisinger in Danville, PA

Exclusion Criteria

Patients:

  • Too far into the vascular access creation process to benefit from the intervention (e.g. completed vascular access surgery appointment or has a surgery appointment scheduled within the next 4 weeks),
  • Inability to consent, or
  • Inability to complete interviews in English

Providers: None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Eksperimentel: Vascular access quality improvement program participants
All participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.
Andet: Vascular Access Navigation and Education Quality Improvement Program
A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
Tidsramme: Pre- and post-intervention, a total of up to 7 months
Patient confidence in ability to navigate the vascular access creation process. Measured using 3 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence in navigating vascular access care.
Pre- and post-intervention, a total of up to 7 months
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
Tidsramme: Pre- and post-intervention, a total of up to 7 months
Patient confidence in ability to self-manage kidney disease. Measured using a modified version of the 8-item Perceived Kidney Disease Self-Management Scale (score range: 8-40). Higher scores reflect higher confidence in self-management of patient's kidney disease.
Pre- and post-intervention, a total of up to 7 months
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
Tidsramme: Pre- and post-intervention, a total of up to 7 months
Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0-10). Higher scores reflect higher knowledge of vascular access.
Pre- and post-intervention, a total of up to 7 months
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
Tidsramme: Pre- and post-intervention, a total of up to 7 months
Provider confidence in ability to help patients navigate the vascular access creation process. Measured using 11 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence supporting patients through the vascular access care process.
Pre- and post-intervention, a total of up to 7 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of North Carolina, Chapel Hill

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Duke University
Geisinger Clinic

Efterforskere

  • Ledende efterforsker: Jennifer Flythe, MD, MPH, University of North Carolina, Chapel Hill
  • Ledende efterforsker: Jamie Green, MD, MS, Geisinger Clinic
  • Ledende efterforsker: Ebony Boulware, MD, MPH, Duke 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

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 (Faktiske)

30. juli 2019

Primær færdiggørelse (Faktiske)

30. april 2020

Studieafslutning (Faktiske)

22. juni 2020

Datoer for studieregistrering

Først indsendt

26. juni 2019

Først indsendt, der opfyldte QC-kriterier

23. juli 2019

Først opslået (Faktiske)

25. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. januar 2021

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18-1912
  • 1R21DK116115 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data generated in this study are protected under data use agreements among Geisinger, Duke University, and the University of North Carolina at Chapel Hill. We cannot directly share the source data without written approval from these institutions. If scientists are interested in accessing de-identified study data, we will work with all institutions to obtain the necessary data use agreement modifications.

IPD-delingstidsramme

Starting 6 months after publication, pending data use agreement modifications.

IPD-delingsadgangskriterier

Principal Investigators will review all requests for data, per data use agreement modifications.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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