A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation (QUANTUM AF)

Quantify Use of Anticoagulation to Improve Management of AF

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Banner Thunderbird
    • Mesa, Arizona, United States, 85206
      • Banner Heart Hospital
    • Mesa, Arizona, United States, 85202
      • Banner Desert Medical Center
    • Mesa, Arizona, United States, 85206
      • Banner Baywood Medical Center
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center
    • Phoenix, Arizona, United States, 85037
      • Banner Estrella
    • Sun City, Arizona, United States, 85351
      • Banner Boswell Medical Center
    • Sun City West, Arizona, United States, 85375
      • Banner Del Webb
    • Tucson, Arizona, United States, 85713
      • Banner University Medical Center - South (BUMC-S)
    • Tucson, Arizona, United States, 85724
      • Banner University Medical Center - Tucson (BUMC-T)
  • Colorado
    • Greeley, Colorado, United States, 80631
      • Banner North Colorado Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Britain, Connecticut, United States, 06050
      • The Hospital of Central Connecticut
  • Illinois
    • Bolingbrook, Illinois, United States, 60440
      • AMITA Adventist Medical Center Bolingbrook
    • Elk Grove Village, Illinois, United States, 60007
      • AMITA Alexian Brothers Medical Center
    • Hinsdale, Illinois, United States, 60521
      • AMITA Adventist Medical Center Hinsdale
    • Hoffman Estates, Illinois, United States, 60169
      • AMITA St. Alexius Medical Center
    • La Grange, Illinois, United States, 60525
      • AMITA Adventist Medical Center La Grange
    • Mount Vernon, Illinois, United States, 62864
      • SSM Health Good Samaritan Hospital
  • Kentucky
    • Danville, Kentucky, United States, 40422
      • Ephraim McDowell Regional Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Hospital
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Medical Center
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Fremont Health Medical Center
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Penn Medicine - Princeton Health
    • Pomona, New Jersey, United States, 08240
      • AtlantiCare
  • New York
    • Bay Shore, New York, United States, 11706
      • Southside Hospital
    • Binghamton, New York, United States, 13905
      • Our Lady of Lourdes Hospital
    • Forest Hills, New York, United States, 11375
      • Long Island Jewish Forest Hills
    • Huntington, New York, United States, 11743
      • Huntington Hospital
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Med Ctr
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
    • Valley Stream, New York, United States, 11580
      • Long Island Jewish Valley Stream
    • Watertown, New York, United States, 13601
      • Samaritan Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • The Jewish Hospital - Mercy
    • Cincinnati, Ohio, United States, 45255
      • Mercy Anderson Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Lima, Ohio, United States, 45801
      • Mercy St. Rita's Medical Center
    • Lorain, Ohio, United States, 44053
      • Mercy Lorain Regional Medical Center
    • Oregon, Ohio, United States, 43616
      • Mercy St. Charles Hospital
    • Richmond Heights, Ohio, United States, 44143
      • University Hospitals Regional Hospitals
    • Toledo, Ohio, United States, 43608
      • Mercy Health St Vincent Medical Center
    • Toledo, Ohio, United States, 43623
      • Mercy St. Anne Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Health Science Center
    • Tulsa, Oklahoma, United States, 74136
      • Saint Francis Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
      • St. Luke's University Health Network
    • Bethlehem, Pennsylvania, United States, 18015
      • St.Luke's University Health Network - St.Luke's Cardiology Associates
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Scranton, Pennsylvania, United States, 18510
      • Geisinger Medical Center
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera McKennan Hospital
  • Texas
    • Abilene, Texas, United States, 79601
      • Hendrick Medical Center
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center
    • Dallas, Texas, United States, 75237
      • Methodist Charlton Medical Center
    • Mansfield, Texas, United States, 76063
      • Methodist Mansfield Medical Center
    • Richardson, Texas, United States, 75082
      • Methodist Richardson Medical Center
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Inova Alexandria Hospital
    • Falls Church, Virginia, United States, 22042
      • Inova Health Care Services
    • Newport News, Virginia, United States, 23601
      • Riverside Regional Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St Marys Medical Center
    • Morgantown, West Virginia, United States, 26505
      • Monongalia County General Hospital Company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)

Collaborators and Investigators

• Sponsor: Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2017
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CR108407; NOPRODAFL0001 (Other Identifier: Janssen Scientific Affairs, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No