- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Danville, Pennsylvania, Förenta staterna, 17822
- Geisinger Danville Nephrology Clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Jennifer Flythe, MD, MPH, University of North Carolina, Chapel Hill
- Huvudutredare: Jamie Green, MD, MS, Geisinger Clinic
- Huvudutredare: Ebony Boulware, MD, MPH, Duke University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 18-1912
- 1R21DK116115 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
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