- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04032613
Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822
- Geisinger Danville Nephrology Clinic
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jennifer Flythe, MD, MPH, University of North Carolina, Chapel Hill
- Hovedetterforsker: Jamie Green, MD, MS, Geisinger Clinic
- Hovedetterforsker: Ebony Boulware, MD, MPH, Duke University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 18-1912
- 1R21DK116115 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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