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Clinical Trials/NCT03382613
NCT03382613TerminatedNot Applicable

Quantify Use of Anticoagulation to Improve Management of AF

Janssen Scientific Affairs, LLC61 sites in 1 country2,000 target enrollmentStarted: December 29, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2,000
Locations
61
Primary Endpoint
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods

Study Overview

Brief Summary

The purpose of this study is to evaluate the impact of a hospital quality improvement (QI) program on the use of guideline-recommended oral anticoagulants (OAC) in hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke. Specifically, the study will determine whether the intervention, compared to Usual Care, will result in a greater increase in the proportion of patients with AF at risk for ischemic stroke who are appropriately treated with OAC.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Inpatient hospitalization
  • Primary or secondary discharge International Classification of Diseases (ICD)-9/10 diagnosis code for AF paroxysmal (I48.0), persistent (I48.1), chronic (I48.2), or unspecified (427.31, I48.91)
  • Proxied Congestive Heart failure (CHA2DS2-VASC) score greater than or equal to (>=) 2 using ICD-9 diagnosis scoring algorithm developed previously. The scoring algorithm will be expanded to include ICD-10 codes
  • Discharged to home, skilled nursing facility, inpatient rehabilitation, or nursing home

Exclusion Criteria

  • Presence of artificial mechanical heart valve by ICD-9/10 diagnosis or procedure code during comorbid identification period or current hospitalization
  • Surgical procedure during hospitalization for open heart surgery, brain, or spine
  • Intravenous heparin given on the day of discharge without warfarin/oral anticoagulant (OAC), antiplatelets, and/or aspirin
  • History of left atrial appendage occlusion, including the Watchman device
  • Any in-hospital (current hospitalization) bleeding identified by ICD-9/10 diagnosis codes

Outcomes

Primary Outcomes

Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods

Time Frame: Baseline up to 20 months

The impact of a hospital quality improvement (QI) program on the use of guideline-recommended oral anticoagulants (OAC) in hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be evaluated by measuring change in the percentage of patients treated with OAC, from baseline to Final Collection Periods.

Secondary Outcomes

  • Effect of Degree of Engagement in the QI Program(End of study (Month 20))
  • Percentage of Patients Readmitted to the Same Hospital(Up to 20 months)
  • Percentage of Patients who Received OAC by Hospital Characteristics Subgroups(End of study (Month 20))
  • Effect of Tools Components of the QI Program on the use of OAC(End of study (Month 20))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (61)

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