A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2000
- 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
- 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 Baywood Medical Center
🇺🇸Mesa, Arizona, United States
St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Geisinger Wyoming Valley
🇺🇸Wilkes-Barre, Pennsylvania, United States
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
Banner University Medical Center - Tucson (BUMC-T)
🇺🇸Tucson, Arizona, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
AMITA Adventist Medical Center Bolingbrook
🇺🇸Bolingbrook, Illinois, United States
AMITA Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
AMITA Adventist Medical Center Hinsdale
🇺🇸Hinsdale, Illinois, United States
SSM Health Good Samaritan Hospital
🇺🇸Mount Vernon, Illinois, United States
AMITA St. Alexius Medical Center
🇺🇸Hoffman Estates, Illinois, United States
Ephraim McDowell Regional Medical Center
🇺🇸Danville, Kentucky, United States
AMITA Adventist Medical Center La Grange
🇺🇸La Grange, Illinois, United States
Fremont Health Medical Center
🇺🇸Fremont, Nebraska, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
AtlantiCare
🇺🇸Pomona, New Jersey, United States
Southside Hospital
🇺🇸Bay Shore, New York, United States
Our Lady of Lourdes Hospital
🇺🇸Binghamton, New York, United States
Huntington Hospital
🇺🇸Huntington, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Long Island Jewish Forest Hills
🇺🇸Forest Hills, New York, United States
Long Island Jewish Med Ctr
🇺🇸New Hyde Park, New York, United States
Long Island Jewish Valley Stream
🇺🇸Valley Stream, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Samaritan Medical Center
🇺🇸Watertown, New York, United States
Mercy St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Mercy Lorain Regional Medical Center
🇺🇸Lorain, Ohio, United States
University Hospitals Regional Hospitals
🇺🇸Richmond Heights, Ohio, United States
Mercy Health St Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Mercy St. Anne Hospital
🇺🇸Toledo, Ohio, United States
Saint Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Geisinger Medical Center
🇺🇸Scranton, Pennsylvania, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
St.Luke's University Health Network - St.Luke's Cardiology Associates
🇺🇸Bethlehem, Pennsylvania, United States
Avera McKennan Hospital
🇺🇸Sioux Falls, South Dakota, United States
Hendrick Medical Center
🇺🇸Abilene, Texas, United States
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Methodist Mansfield Medical Center
🇺🇸Mansfield, Texas, United States
Methodist Richardson Medical Center
🇺🇸Richardson, Texas, United States
Methodist Charlton Medical Center
🇺🇸Dallas, Texas, United States
Inova Alexandria Hospital
🇺🇸Alexandria, Virginia, United States
Riverside Regional Medical Center
🇺🇸Newport News, Virginia, United States
Banner North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Inova Health Care Services
🇺🇸Falls Church, Virginia, United States
Banner Estrella
🇺🇸Phoenix, Arizona, United States
The Jewish Hospital - Mercy
🇺🇸Cincinnati, Ohio, United States
Mercy Anderson Hospital
🇺🇸Cincinnati, Ohio, United States
Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
St. Luke's University Health Network
🇺🇸Allentown, Pennsylvania, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
Monongalia County General Hospital Company
🇺🇸Morgantown, West Virginia, United States
Banner University Medical Center - South (BUMC-S)
🇺🇸Tucson, Arizona, United States
Banner Del Webb
🇺🇸Sun City West, Arizona, United States
Penn Medicine - Princeton Health
🇺🇸Plainsboro, New Jersey, United States
Banner Heart Hospital
🇺🇸Mesa, Arizona, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
St Marys Medical Center
🇺🇸Huntington, West Virginia, United States
Banner Thunderbird
🇺🇸Glendale, Arizona, United States
Banner Boswell Medical Center
🇺🇸Sun City, Arizona, United States
Mercy St. Charles Hospital
🇺🇸Oregon, Ohio, United States