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

Terminated

• Conditions: Atrial Fibrillation

• Registration Number: NCT03382613
• Lead Sponsor: Janssen Scientific Affairs, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Study Start: 2017-12-29
• Status Verified: 2019-12
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-03
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods	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 Outcome Measures

Name	Time	Method
Effect of Degree of Engagement in the QI Program	End of study (Month 20)	A performance dashboard will be implemented to aggregate and display performance data.
Percentage of Patients Readmitted to the Same Hospital	Up to 20 months	Percentage 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 Subgroups	End 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 OAC	End 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.

Trial Locations

Locations (61)

Banner Thunderbird; 🇺🇸 Glendale, Arizona, United States

Banner Desert Medical Center; 🇺🇸 Mesa, Arizona, United States

Banner Baywood Medical Center; 🇺🇸 Mesa, Arizona, United States

Banner Heart Hospital; 🇺🇸 Mesa, Arizona, United States

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

Banner Estrella; 🇺🇸 Phoenix, Arizona, United States

Banner Del Webb; 🇺🇸 Sun City West, Arizona, United States

Banner Boswell Medical Center; 🇺🇸 Sun City, Arizona, United States

Banner University Medical Center - South (BUMC-S); 🇺🇸 Tucson, Arizona, United States

Banner University Medical Center - Tucson (BUMC-T); 🇺🇸 Tucson, Arizona, United States

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