Clinical trial NCT03058913: OEIS Outcome Data Registry
Official title: OEIS (Outpatient Endovascular and Interventional Society) Outcome Data Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: Outpatient Endovascular and Interventional Society
Sponsor class: OTHER
Collaborators: name: Syntactx
First posted: 2017-02-23
Enrollment: 600000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients meeting the registry diagnostic and procedure inclusion criteria and that are treated at participating facilities by participating clinicians.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Antiplatelet Therapy (ACC/AHA/PAD Coalition)
timeFrame: 30 days
measure: Preventive Care and Screening: Tobacco Use
timeFrame: 30 days
measure: Lipid-Lowering Medications for Patients with PAD
timeFrame: 30 days
measure: Optimal vascular care
timeFrame: 30 days
measure: Preventive Care and Screening: Influenza Immunization.
timeFrame: 30 days
measure: Pneumonia Vaccination Status for Older Adults.
timeFrame: 30 days
measure: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented.
timeFrame: 30 days
measure: Appropriate non-invasive arterial testing for patients with intermittent claudication who are undergoing a lower extremity peripheral vascular intervention.
timeFrame: 30 days
measure: Appropriate non-invasive arterial testing for patients with critical limb ischemia who are undergoing a LE peripheral vascular intervention.
timeFrame: 30 days
measure: Emergent transfer from an outpatient, ambulatory surgical center, or office setting.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hoffman Estates
country: United States
facility: Outpatient Endovascular Interventional Society (OEIS)
state: Illinois
Study officials:
References:
citation: 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.
citation: Murer CG. Significant changes for ASC payment systems. Rehab Manag. 2007 Nov;20(9):42, 44-5. No abstract available.
citation: 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.
citation: Kutscher B. Outpatient care takes the inside track. Mod Healthc. 2012 Aug 6;42(32):24-6. No abstract available.
citation: 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.