Study Stopped
Operating Company decided to stop study due to strategic realignment and budgetary reasons
A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation
QUANTUM AF
Quantify Use of Anticoagulation to Improve Management of AF
2 other identifiers
observational
2,000
1 country
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedStudy Start
First participant enrolled
December 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2019
CompletedDecember 26, 2019
December 1, 2019
1.9 years
December 19, 2017
December 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Percentage of Patients Readmitted to the Same Hospital
Up to 20 months
Percentage of Patients who Received OAC by Hospital Characteristics Subgroups
End of study (Month 20)
Effect of Tools Components of the QI Program on the use of OAC
End of study (Month 20)
Effect of Degree of Engagement in the QI Program
End of study (Month 20)
Study Arms (2)
Quality Improvement (QI) Program
Hospitals assigned to the QI program arm will begin the 4-month Preparatory Phase which is designed to introduce the institutional baseline reporting tools and materials related to performance improvement, and gain insight into their gaps in treatment, followed by 15 month Implementation Phase, which will consist of education, process, and engagement activities that are targeted at the hospital and healthcare provider level and then the Measurement Period at which time hospitals will complete a final survey to document specific interventions that were successfully implemented and perform a final retrospective chart review on selected patients.
Usual Care
Hospitals assigned to the Usual Care arm will not participate in the structured QI program but will continue with their standard hospital practice in treating patients with atrial fibrillation (AF) at risk for ischemic stroke. Hospitals will also complete a final survey and final retrospective chart reviews during the Measurement Period.
Eligibility Criteria
Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Banner Thunderbird
Glendale, Arizona, 85306, United States
Banner Desert Medical Center
Mesa, Arizona, 85202, United States
Banner Baywood Medical Center
Mesa, Arizona, 85206, United States
Banner Heart Hospital
Mesa, Arizona, 85206, United States
Banner University Medical Center
Phoenix, Arizona, 85006, United States
Banner Estrella
Phoenix, Arizona, 85037, United States
Banner Boswell Medical Center
Sun City, Arizona, 85351, United States
Banner Del Webb
Sun City West, Arizona, 85375, United States
Banner University Medical Center - South (BUMC-S)
Tucson, Arizona, 85713, United States
Banner University Medical Center - Tucson (BUMC-T)
Tucson, Arizona, 85724, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
AMITA Adventist Medical Center Bolingbrook
Bolingbrook, Illinois, 60440, United States
AMITA Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
AMITA Adventist Medical Center Hinsdale
Hinsdale, Illinois, 60521, United States
AMITA St. Alexius Medical Center
Hoffman Estates, Illinois, 60169, United States
AMITA Adventist Medical Center La Grange
La Grange, Illinois, 60525, United States
SSM Health Good Samaritan Hospital
Mount Vernon, Illinois, 62864, United States
Ephraim McDowell Regional Medical Center
Danville, Kentucky, 40422, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Fremont Health Medical Center
Fremont, Nebraska, 68025, United States
Penn Medicine - Princeton Health
Plainsboro, New Jersey, 08536, United States
AtlantiCare
Pomona, New Jersey, 08240, United States
Southside Hospital
Bay Shore, New York, 11706, United States
Our Lady of Lourdes Hospital
Binghamton, New York, 13905, United States
Long Island Jewish Forest Hills
Forest Hills, New York, 11375, United States
Huntington Hospital
Huntington, New York, 11743, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Med Ctr
New Hyde Park, New York, 11040, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Long Island Jewish Valley Stream
Valley Stream, New York, 11580, United States
Samaritan Medical Center
Watertown, New York, 13601, United States
The Jewish Hospital - Mercy
Cincinnati, Ohio, 45236, United States
Mercy Anderson Hospital
Cincinnati, Ohio, 45255, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Mercy St. Rita's Medical Center
Lima, Ohio, 45801, United States
Mercy Lorain Regional Medical Center
Lorain, Ohio, 44053, United States
Mercy St. Charles Hospital
Oregon, Ohio, 43616, United States
University Hospitals Regional Hospitals
Richmond Heights, Ohio, 44143, United States
Mercy Health St Vincent Medical Center
Toledo, Ohio, 43608, United States
Mercy St. Anne Hospital
Toledo, Ohio, 43623, United States
Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Saint Francis Hospital
Tulsa, Oklahoma, 74136, United States
St. Luke's University Health Network
Allentown, Pennsylvania, 18102, United States
St.Luke's University Health Network - St.Luke's Cardiology Associates
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Avera McKennan Hospital
Sioux Falls, South Dakota, 57105, United States
Hendrick Medical Center
Abilene, Texas, 79601, United States
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Methodist Charlton Medical Center
Dallas, Texas, 75237, United States
Methodist Mansfield Medical Center
Mansfield, Texas, 76063, United States
Methodist Richardson Medical Center
Richardson, Texas, 75082, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Inova Health Care Services
Falls Church, Virginia, 22042, United States
Riverside Regional Medical Center
Newport News, Virginia, 23601, United States
St Marys Medical Center
Huntington, West Virginia, 25702, United States
Monongalia County General Hospital Company
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2017
First Posted
December 26, 2017
Study Start
December 29, 2017
Primary Completion
December 3, 2019
Study Completion
December 3, 2019
Last Updated
December 26, 2019
Record last verified: 2019-12