Clinical trial NCT03382613: A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation
Official title: Quantify Use of Anticoagulation to Improve Management of AF
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods
timeFrame: Baseline up to 20 months
Secondary outcomes:
measure: Percentage of Patients Readmitted to the Same Hospital
timeFrame: Up to 20 months
measure: Percentage of Patients who Received OAC by Hospital Characteristics Subgroups
timeFrame: End of study (Month 20)
measure: Effect of Tools Components of the QI Program on the use of OAC
timeFrame: End of study (Month 20)
measure: Effect of Degree of Engagement in the QI Program
timeFrame: End of study (Month 20)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Banner Thunderbird
state: Arizona
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Mesa
country: United States
facility: Banner Baywood Medical Center
state: Arizona
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner Estrella
state: Arizona
city: Sun City West
country: United States
facility: Banner Del Webb
state: Arizona
city: Sun City
country: United States
facility: Banner Boswell Medical Center
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center - South (BUMC-S)
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson (BUMC-T)
state: Arizona
city: Greeley
country: United States
facility: Banner North Colorado Medical Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: Bolingbrook
country: United States
facility: AMITA Adventist Medical Center Bolingbrook
state: Illinois
city: Elk Grove Village
country: United States
facility: AMITA Alexian Brothers Medical Center
state: Illinois
city: Hinsdale
country: United States
facility: AMITA Adventist Medical Center Hinsdale
state: Illinois
city: Hoffman Estates
country: United States
facility: AMITA St. Alexius Medical Center
state: Illinois
city: La Grange
country: United States
facility: AMITA Adventist Medical Center La Grange
state: Illinois
city: Mount Vernon
country: United States
facility: SSM Health Good Samaritan Hospital
state: Illinois
city: Danville
country: United States
facility: Ephraim McDowell Regional Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Fremont
country: United States
facility: Fremont Health Medical Center
state: Nebraska
city: Plainsboro
country: United States
facility: Penn Medicine - Princeton Health
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare
state: New Jersey
city: Bay Shore
country: United States
facility: Southside Hospital
state: New York
city: Binghamton
country: United States
facility: Our Lady of Lourdes Hospital
state: New York
city: Forest Hills
country: United States
facility: Long Island Jewish Forest Hills
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Med Ctr
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Valley Stream
country: United States
facility: Long Island Jewish Valley Stream
state: New York
city: Watertown
country: United States
facility: Samaritan Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Jewish Hospital - Mercy
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Anderson Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Lima
country: United States
facility: Mercy St. Rita's Medical Center
state: Ohio
city: Lorain
country: United States
facility: Mercy Lorain Regional Medical Center
state: Ohio
city: Oregon
country: United States
facility: Mercy St. Charles Hospital
state: Ohio
city: Richmond Heights
country: United States
facility: University Hospitals Regional Hospitals
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St Vincent Medical Center
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Anne Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Health Science Center
state: Oklahoma
city: Tulsa
country: United States
facility: Saint Francis Hospital
state: Oklahoma
city: Allentown
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Bethlehem
country: United States
facility: St.Luke's University Health Network - St.Luke's Cardiology Associates
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Scranton
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital
state: South Dakota
city: Abilene
country: United States
facility: Hendrick Medical Center
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Methodist Charlton Medical Center
state: Texas
city: Mansfield
country: United States
facility: Methodist Mansfield Medical Center
state: Texas
city: Richardson
country: United States
facility: Methodist Richardson Medical Center
state: Texas
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Huntington
country: United States
facility: St Marys Medical Center
state: West Virginia
city: Morgantown
country: United States
facility: Monongalia County General Hospital Company
state: West Virginia
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: