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

Atrial Fibrillation Clinical Trial

— QUANTUM AF  

Official title:

Quantify Use of Anticoagulation to Improve Management of AF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03382613
• Other study ID #: CR108407
• Secondary ID: NOPRODAFL0001
• Status: Terminated
• Start date: December 29, 2017
• Est. completion date: December 3, 2019

Study information

• Verified date: December 2019
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2000
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Hendrick Medical Center	Abilene	Texas
United States	Inova Alexandria Hospital	Alexandria	Virginia
United States	St. Luke's University Health Network	Allentown	Pennsylvania
United States	AnMed Health	Anderson	South Carolina
United States	St. Agnes Hospital	Baltimore	Maryland
United States	Southside Hospital	Bay Shore	New York
United States	St.Luke's University Health Network - St.Luke's Cardiology Associates	Bethlehem	Pennsylvania
United States	Our Lady of Lourdes Hospital	Binghamton	New York
United States	AMITA Adventist Medical Center Bolingbrook	Bolingbrook	Illinois
United States	Mercy Anderson Hospital	Cincinnati	Ohio
United States	The Jewish Hospital - Mercy	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Methodist Charlton Medical Center	Dallas	Texas
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	Ephraim McDowell Regional Medical Center	Danville	Kentucky
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	AMITA Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Inova Health Care Services	Falls Church	Virginia
United States	Long Island Jewish Forest Hills	Forest Hills	New York
United States	Fremont Health Medical Center	Fremont	Nebraska
United States	Banner Thunderbird	Glendale	Arizona
United States	Banner North Colorado Medical Center	Greeley	Colorado
United States	Hartford Hospital	Hartford	Connecticut
United States	AMITA Adventist Medical Center Hinsdale	Hinsdale	Illinois
United States	AMITA St. Alexius Medical Center	Hoffman Estates	Illinois
United States	Huntington Hospital	Huntington	New York
United States	St Marys Medical Center	Huntington	West Virginia
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	AMITA Adventist Medical Center La Grange	La Grange	Illinois
United States	Mercy St. Rita's Medical Center	Lima	Ohio
United States	Mercy Lorain Regional Medical Center	Lorain	Ohio
United States	North Shore University Hospital	Manhasset	New York
United States	Methodist Mansfield Medical Center	Mansfield	Texas
United States	Banner Baywood Medical Center	Mesa	Arizona
United States	Banner Desert Medical Center	Mesa	Arizona
United States	Banner Heart Hospital	Mesa	Arizona
United States	Monongalia County General Hospital Company	Morgantown	West Virginia
United States	SSM Health Good Samaritan Hospital	Mount Vernon	Illinois
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Long Island Jewish Med Ctr	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	New York
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Mercy St. Charles Hospital	Oregon	Ohio
United States	Banner Estrella	Phoenix	Arizona
United States	Banner University Medical Center	Phoenix	Arizona
United States	Penn Medicine - Princeton Health	Plainsboro	New Jersey
United States	AtlantiCare	Pomona	New Jersey
United States	Methodist Richardson Medical Center	Richardson	Texas
United States	University Hospitals Regional Hospitals	Richmond Heights	Ohio
United States	Geisinger Medical Center	Scranton	Pennsylvania
United States	Avera McKennan Hospital	Sioux Falls	South Dakota
United States	Banner Boswell Medical Center	Sun City	Arizona
United States	Banner Del Webb	Sun City West	Arizona
United States	Mercy Health St Vincent Medical Center	Toledo	Ohio
United States	Mercy St. Anne Hospital	Toledo	Ohio
United States	Banner University Medical Center - South (BUMC-S)	Tucson	Arizona
United States	Banner University Medical Center - Tucson (BUMC-T)	Tucson	Arizona
United States	Saint Francis Hospital	Tulsa	Oklahoma
United States	Long Island Jewish Valley Stream	Valley Stream	New York
United States	Samaritan Medical Center	Watertown	New York
United States	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods	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.	Baseline up to 20 months
Secondary	Percentage of Patients Readmitted to the Same Hospital	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.	Up to 20 months
Secondary	Percentage of Patients who Received OAC by Hospital Characteristics Subgroups	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.	End of study (Month 20)
Secondary	Effect of Tools Components of the QI Program on the use of OAC	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.	End of study (Month 20)
Secondary	Effect of Degree of Engagement in the QI Program	A performance dashboard will be implemented to aggregate and display performance data.	End of study (Month 20)