OEIS Outcome Data Registry

NCT03058913 | Unknown

• 1 other identifier: 2016-OEIS-01
• Study Type: observational
• Target: 600,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (10)

• Antiplatelet Therapy (ACC/AHA/PAD Coalition)

  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

  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

  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

  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.

  30 days

• Pneumonia Vaccination Status for Older Adults.

  30 days

• Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented.

  30 days

• Appropriate non-invasive arterial testing for patients with intermittent claudication who are undergoing a lower extremity peripheral vascular intervention.

  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.

  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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Outpatient Endovascular and Interventional Society: lead
• Syntactx: collaborator

Study Sites (1)

Outpatient Endovascular Interventional Society (OEIS)

Hoffman Estates, Illinois, 60169, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 21433218 BACKGROUND

• Murer CG. Significant changes for ASC payment systems. Rehab Manag. 2007 Nov;20(9):42, 44-5. No abstract available.

  PMID: 18229814 BACKGROUND

• 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.

  PMID: 12117139 BACKGROUND

• Kutscher B. Outpatient care takes the inside track. Mod Healthc. 2012 Aug 6;42(32):24-6. No abstract available.

  PMID: 22953497 BACKGROUND

• 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.

  PMID: 27381926 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Dhru Bhatt

CONTACT

8885486347; DBhatt@association-resources.com

Elizabeth Ouriel

CONTACT

2128786882; eouriel@syntactx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 23, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)