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A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation

Quantify Use of Anticoagulation to Improve Management of AF

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03382613
Acronym
QUANTUM AF
Enrollment
2000
Registered
2017-12-26
Start date
2017-12-29
Completion date
2019-12-03
Last updated
2019-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

None listed

Sponsors

Janssen Scientific Affairs, LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection PeriodsBaseline up to 20 monthsThe 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

MeasureTime frameDescription
Percentage of Patients Readmitted to the Same HospitalUp to 20 monthsPercentage of patients readmitted to the same hospital for all-cause readmissions, stroke-related readmissions, cardiovascular (CV)-related readmissions, and bleeding- related readmissions will be evaluated.
Percentage of Patients who Received OAC by Hospital Characteristics SubgroupsEnd of study (Month 20)Use of OAC at the end of study by hospital characteristics subgroups (that is, patients care mix, infrastructure-bed size, staffing, academic status, location, urban/rural, provider) will be determined.
Effect of Tools Components of the QI Program on the use of OACEnd of study (Month 20)The effect of the educational process-based components of the QI program relative to the Usual Care arm on the use of OAC will be evaluated.
Effect of Degree of Engagement in the QI ProgramEnd of study (Month 20)A performance dashboard will be implemented to aggregate and display performance data.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026