- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03058913
OEIS Outcome Data Registry
27. september 2022 opdateret af: Outpatient Endovascular and Interventional Society
OEIS (Outpatient Endovascular and Interventional Society) Outcome Data Registry
This registry is created under the sponsorship of the Outpatient Endovascular and Interventional Society (OEIS) to monitor the clinical course and treatment outcomes of patients undergoing office-based endovascular procedures.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
600000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dhru Bhatt
- Telefonnummer: 8885486347
- E-mail: DBhatt@association-resources.com
Undersøgelse Kontakt Backup
- Navn: Elizabeth Ouriel
- Telefonnummer: 2128786882
- E-mail: eouriel@syntactx.com
Studiesteder
-
-
Illinois
-
Hoffman Estates, Illinois, Forenede Stater, 60169
- Rekruttering
- Outpatient Endovascular Interventional Society (OEIS)
-
Kontakt:
- Jeff Carr
- Telefonnummer: 903-521-6004
- E-mail: jeffcarr@me.com
-
-
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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All patients meeting the registry diagnostic and procedure inclusion criteria and that are treated at participating facilities by participating clinicians.
Beskrivelse
Inclusion Criteria:
- Patient is 18 years of age or older;
- Patient is identified as having undergone a percutaneous transluminal vascular intervention or attempted intervention, in an ambulatory (outpatient) facility, for the treatment of peripheral vascular disease within native arteries or bypass grafts, from the infrarenal aorta distally to the feet.
Exclusion Criteria:
- Patient treated for a non-eligible condition or procedure
- Diagnostic procedures without intervention or attempted interventions
- Serious mental illness that might preclude subject's ability to comply with follow up
- Life expectancy of less than 6 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antiplatelet Therapy (ACC/AHA/PAD Coalition)
Tidsramme: 30 days
|
To collect the clinical variables of Patients undergoing endovascular procedures in an outpatient angiograPercentage of patients with PAD that have been prescribed an antiplatelet medication at the reported encounter.
|
30 days
|
|
Preventive Care and Screening: Tobacco Use
Tidsramme: 30 days
|
Screening and Cessation Intervention.
Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user.
|
30 days
|
|
Lipid-Lowering Medications for Patients with PAD
Tidsramme: 30 days
|
The rate at which patients with documented peripheral artery disease have documentation of a currently prescribed antihyperlipidemic medication treatment.
This may include one of the following: Statin, Bile acid sequestrants, Niacin, Ezetemibe, Fibrates, PCSK9 Inhibitors
|
30 days
|
|
Optimal vascular care
Tidsramme: 30 days
|
This measure is a composite score of appropriate vascular care measures for treatment of PAD.
This measure is a composite result of 1: Antiplatelet Therapy; 2: Preventive Care and Screening: Tobacco Use; and 3: Lipid-Lowering Medications (Statin) for Patients with PAD
|
30 days
|
|
Preventive Care and Screening: Influenza Immunization.
Tidsramme: 30 days
|
30 days
|
|
|
Pneumonia Vaccination Status for Older Adults.
Tidsramme: 30 days
|
30 days
|
|
|
Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented.
Tidsramme: 30 days
|
30 days
|
|
|
Appropriate non-invasive arterial testing for patients with intermittent claudication who are undergoing a lower extremity peripheral vascular intervention.
Tidsramme: 30 days
|
Proportion of patients with non-invasive evaluations present/available prior to lower extremity peripheral vascular interventions in patients with intermittent claudication.
|
30 days
|
|
Appropriate non-invasive arterial testing for patients with critical limb ischemia who are undergoing a LE peripheral vascular intervention.
Tidsramme: 30 days
|
Proportion of patients with non-invasive evaluations present/available prior to LE peripheral vascular interventions in patients with critical limb ischemia.
|
30 days
|
|
Emergent transfer from an outpatient, ambulatory surgical center, or office setting.
Tidsramme: 30 days
|
Rate of emergent transfer from an outpatient, ASC, or office setting to an acute care facility as a result of an invasive peripheral vascular intervention.
|
30 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
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
- Carey K, Burgess JF Jr, Young GJ. Hospital competition and financial performance: the effects of ambulatory surgery centers. Health Econ. 2011 May;20(5):571-81. doi: 10.1002/hec.1617.
- Murer CG. Significant changes for ASC payment systems. Rehab Manag. 2007 Nov;20(9):42, 44-5. No abstract available.
- Lapetina EM, Armstrong EM. Preventing errors in the outpatient setting: a tale of three states. Health Aff (Millwood). 2002 Jul-Aug;21(4):26-39. doi: 10.1377/hlthaff.21.4.26.
- Kutscher B. Outpatient care takes the inside track. Mod Healthc. 2012 Aug 6;42(32):24-6. No abstract available.
- Lin PH, Yang KH, Kollmeyer KR, Uceda PV, Ferrara CA, Feldtman RW, Caruso J, Mcquade K, Richmond JL, Kliner CE, Egan KE, Kim W, Saines M, Leichter R, Ahn SS. Treatment outcomes and lessons learned from 5134 cases of outpatient office-based endovascular procedures in a vascular surgical practice. Vascular. 2017 Apr;25(2):115-122. doi: 10.1177/1708538116657506. Epub 2016 Jul 9.
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)
1. februar 2017
Primær færdiggørelse (Forventet)
1. december 2025
Studieafslutning (Forventet)
1. december 2025
Datoer for studieregistrering
Først indsendt
9. februar 2017
Først indsendt, der opfyldte QC-kriterier
16. februar 2017
Først opslået (Faktiske)
23. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-OEIS-01
Plan for individuelle deltagerdata (IPD)
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