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National Quality Improvement Program to Reduce Stroke Risk in Patients with Atrial Fibrillation (AF)
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QUANTUM AF is about reducing occurrences of ischemic stroke in patients with atrial fibrillation (AF) and at risk of stroke. We seek to increase the use of guideline-directed oral anticoagulation (OAC) therapy in this patient population. A high percentage of these patients do not currently receive appropriate OAC therapy. This gap represents a unique opportunity to explore methods to improve quality of care. Study objectives will be achieved through education and quality improvement activities.


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Goals of the Quality Improvement Program/Purpose of the Research Study

Quality Improvement Goals
  • The primary goal of the quality improvement effort within each hospital is the reduction of stroke risk and incidence in patients with AF through improved utilization of guideline-directed anticoagulation therapy.
  • As in the research component of the study, increased adherence to the guideline-directed therapeutic use of OACs will be a key focus, but the downstream quality improvement measures may involve stroke rates, effective transition of care, and better understanding of fall risks, to name a few.
  • Quality improvement outcome goals will be defined by each participating QI Arm hospital.
Purpose of Research Study:
  • The purpose of the research study is to evaluate the impact of a hospital‐based Quality Improvement (QI) program on the use of guideline‐recommended oral anticoagulation (OAC) in hospitalized patients with atrial fibrillation (AF) who are at risk for ischemic stroke.
  • The primary study measure will be the use of OAC the day before or the day of discharge from the hospital.
  • The primary measure comparison will be the change in the proportion of patients treated with OAC, from baseline to final collection periods, in each of the two study arms..
This Is How We Get It Done
Premier: Simple… It is What We Do

  • Promote reflection and self-assessment
  • Provide timely, specific feedback
  • Continuous learning and improvement
  • Assess learner and system needs
  • Define and lead to verifiable outcomes
  • Motivate learners
  • Make it relevant to practice
  • Promote interaction and engagement

What is the Opportunity at Your Hospital?


Consistent Under-treatment Across all Sites

Despite effective medications, stroke risk calculators, and evidence-based guidelines, approximately 49% of eligible patients do not receive guideline-directed anticoagulation therapy, placing them at higher risk for stroke.1 Where do you think you fall in this graphical depiction of actual Premier Healthcare Database (PHD) data on OAC rates at 801 Premier member hospitals?




ED Visits, Readmissions, Hospitalizations

Cost of Care

With higher rates of ED visits and hospitalizations comes increased cost of care and economic burden on the health care system.







Frequently Asked Questions

Study Background
What does the name QUANTUM-AF stand for?
  • Quantify Use of ANTicoagUlation to improve Management of Atrial Fibrillation
What is the purpose of the study, and what are the goals?
  • Patients with atrial fibrillation (Afib) have a higher risk of stroke than non-Afib patients. This risk has been shown to be reduced with the use of oral anticoagulation therapy (OAC).
  • A high percentage of patients who have Afib and are at risk of stroke, do not currently receive appropriate OAC therapy. This gap represents a unique opportunity to explore methods to improve quality of care.
  • One aim of the QUANTUM AF study is to help reduce occurrences of ischemic stroke in patients with Afib who are at risk of stroke. Toward that end, this project seeks to increase the use of guideline-directed OAC therapy in this patient population.
  • The primary study measure will be the use of OAC the day before or the day of discharge from the hospital.
  • The primary measure comparison will be the change in the proportion of patients treated with OAC, from baseline to final collection periods.
When does this study start/stop?
  • The anticipated study period will be from September 2017 through December 2020.
  • Individual sites will participate over a 20-month period within that overall study period.
What is the study type/design?
  • This is a cluster-randomized study
    • Hospitals (rather than individual subjects) are randomized into two study arms:

      1. Quality Improvement Program Arm (QI): The institutions randomized to this arm will participate in multiple activities, including team development, educational activities, coaching calls, data and dashboard support, best practice sharing, and QI support to assist in the sites’ development of strategies for this patient population.
      2. Usual Care Arm: Institutions randomized to this arm will continue the current practice around this population and will be used as the control arm of this study.
What is the Difference between Quality Improvement and Quality Improvement Research?
  • Research studies involve systematic, scientific inquiry to answer specific research questions or test hypotheses to be able to create generalizable knowledge.
  • Quality Improvement is continually improving metrics of interests through a series of interventions over time based on prior learnings to attain sustainable change in behavior/performance. Interventions can evolve over time and QI is more fluid.
  • It is proof of effectiveness (research) vs. continuous sustainable improvements (QI)
  • This study will combine the two methodologies.

Study Participation
Which hospitals are eligible to participate in this study?
  • A total of 150 hospitals will participate in this study. There will be roughly 75 hospitals in each arm, and each hospital will have a minimum population of 70 patients per quarter with a primary or secondary diagnosis of Afib.
  • Study hospitals must be active QualityAdvisor™ (QA) participants, submitting data regularly to Premier’s benchmarking tool for a period of at least 6 months prior to their start in the study.
  • While participation in the Premier Healthcare Database is not a requirement, sites that have opted-out of the PHD will be required to sign a contract rider that gives the study team permission to de-identify their QA data for the purposes of the study.
How much work is involved with participation in the study?
  • The workload will vary from institution to institution based on the randomization arm and the activities developed at the site level.
  • In sites randomized to the Usual Care arm, light reporting workload should be expected beyond current practice.
  • In sites randomized to the QI Program arm, the workload should be similar to work invested in other QI activities at the site, with the following exceptions:
    • Because QUANTUM AF is a research project, there will be additional regulatory components (e.g. IRB submissions, etc.) that the research team will support. Hospitals will have support for these activities form Janssen and/or Premier as needed
    • Premier will provide resources such as education, coaching, and data and dashboard analysis to help each site succeed in the program (similar to other Premier QI Collaboratives). Participants will participate in 5 online webinars, which include case scenarios and expert panel sessions, scheduled for 60 minutes each. There will also be coaching and feedback conference calls, scheduled for 60 minutes each to provide ongoing feedback and recommendations for change.
    • Each site will identify important leadership positions as well as other team members who can help with study participation.
Do all participating sites perform the same activities in the study?
  • No, there will be two arms in the study: QI Program hospitals and Usual Care hospitals. There are different activities for each arm of the study.
  • Randomization will occur as groups of hospitals contract to participate in the study.
  • This is a self-directed study. Exact activities will vary by site according to what each site decides works best for them. Standard activities for all sites in the QI arm include webinars, coaching calls, chart review and analysis, and regular data upload.
Why would a hospital/institution want to participate? What is the value proposition for participation?
  • Potential for stroke rate reduction
  • Potential for improved care for this patient population
  • Potential for improved guideline adherence
  • Participation in a nationally recognized research effort
  • Site payments to help cover the costs of the study
  • Involvement could potentially benefit work in other improvement areas such as readmission reduction, falls management, or transition of care initiatives, as examples.
For what periods of time will data be collected on my patients?
  • Data will be extracted from patient records for the following timeframes, and updated monthly through the study period.
    • A baseline period including the 3 months prior to study start
    • During study preparatory period from month 1 thru month 4
    • Additionally, up to 15 months of data following the initiation of the preparatory phase, will be reviewed to determine patient history of atrial fibrillation and stroke.
Will I have access to the study results?
  • Following conclusion of the study, results will be shared with participating sites, who will be at liberty to share as they desire within their organization.
  • Study results will also be submitted for publication in a peer-reviewed journal.
How are hospitals compensated?
  • The study sponsor will compensate each site based on confirmation of the site’s completion of various protocol-required tasks
  • The amount of the compensation will be determined and negotiated directly between the sponsor (Janssen) and the participating site.

Sponsorship
Who is the sponsor of this project?
  • Janssen Scientific Affairs, LLC
Why is Janssen sponsoring this study?
  • Both Premier and Janssen believe this study can have a positive impact on the treatment of AF patients by increasing the guideline-directed use of anticoagulation therapy in AF patients at risk of stroke.
  • Prospective studies in which Premier Research Services participates are at the therapeutic areas level, and are never drug specific.
  • Although the sponsor has been involved with the study design, the study will undergo IRB review, and Premier's internal compliance and legal teams have already evaluated and approved it.
  • The sponsor will not have access to hospital or patient-specific information and will not be involved in the hospital recruiting processes. However, once the hospital self-identifies to Janssen via the online Feasibility Questionnaire, they will help coordinate IRB submission and site contracting for selected sites.
What data will Janssen have access to?
  • At the end of the study, Janssen will receive aggregated results of analysis at the study level and de-identified results at the hospital level generated from the research. The intent will be to show performance achieved in relation to the Research Question.
  • The sponsor will have access to only the aggregated and de-identified data, and hospital identifiers will also be removed.

Premier Applied Science
Who is Premier?
  • We are a healthcare improvement company uniting an alliance of approximately 3,700 hospitals (74% of U.S. community hospitals) and 130,000 other providers to transform healthcare in the United States. Our provider-centric model allows us to develop products from within our membership and introduce them across the entire member base. Bringing industry-sponsored and grant-funded research opportunities aligning with members’ corporate goals is one of many services we offer. This study is an example of how we work to provide a shared infrastructure for healthcare improvement while cultivating a collaborative approach to addressing common healthcare challenges.
What is Premier’s role?
  • Premier’s role in the project includes project management, site identification and recruitment, coordination of steering committee activities, coordination and development of QI elements, data collection and dashboard development, coordination of manuscripts and publications, as well as other activities.
  • A Premier implementation team will work closely with the study teams participating in the QI program arm to ensure completion of all requirements and activities associated with the various phases of the QI program.
  • The primary data source for the study will be the Premier Healthcare Database (PHD), which is a statistically de-identified, HIPAA-compliant database used for observational studies and retrospective and/or prospective research.
How is this project different from other Premier QI Collaboratives?
  • Although this research study will use the Premier’s Quality Improvement methodology, similar to QUEST and other QI Collaboratives, this is NOT a QUEST initiative.
    • The research measurements are a key and required component of the study.
    • The QI methodology will apply only to institutions randomized to the QI arm.
    • Sites will be compensated by the Study Sponsor for their participation based on the site contract.
    • Peer-reviewed manuscripts are an intended outcome of this project work.
Are continuing education (CE) credits offered for viewing and completing the educational modules?
  • No, continuing education credits are not offered for completing the educational modules or for participation in the study.

More Information
How can I get more information?

Please contact our study recruitment team via the phone or email address listed here: Thank you for your interest in QUANTUM AF.
Study Publications






QUANTUM AF Steering Committee

Christopher B. Granger, MD, FACC, FAHA
(Chair)
Professor of Medicine, Department of Cardiology
Duke University Medical Center
Elaine M. Hylek, MD
(Chair)
Professor of Medicine, Department of Medicine
Boston University School of Medicine
Sean D. Pokorney, MD, MBA
Research Faculty Member
Duke University Medical Center
Kevin J. Anstrom, PhD, MS
Associate Director of Biostatistics and Faculty Director of Data Solutions for Clinical Trials
Duke University Medical Center
Mark Alberts, MD
Physician in Chief
Hartford HealthCare
Peter Berger, MD
Independent Consultant
Michael P. Dorsch, PharmD, MS, FCCP, FAHA, BCPS (AQ Cardiology)
Clinical Associate Professor, University of Michigan College of Pharmacy
Clinical Pharmacist in Cardiology, University of Michigan Health System
University of Michigan
Gregory J. Fermann, MD
Professor of Emergency Medicine
University of Cincinnati College of Medicine
Susan Marx Mashni, Pharm D, BCPS
Chief Pharmacy Officer
Mercy Health
Gerald V. Naccarelli, M.D., FACC, FAHA, FHRS
Bernard Trabin Chair in Cardiology, Professor of Medicine, Chief of the Division of Cardiology, and Director of the Cardiovascular Center
Pennsylvania State University College of Medicine/Milton S. Hershey Medical Center
Eva Kline-Rogers, MS, NP, AACC
Cardiovascular Nurse Practitioner
Co-director for MCORRP (Michigan Cardiovascular Outcomes Research and Reporting Program)
University of Michigan
Kevin Thomas, MD
Associate Professor of Medicine in the Division of Cardiovascular Disease
Duke University Medical Center
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References

  1. Pokorney SD, et al. Low rates of oral anticoagulation use among patients hospitalized with atrial fibrillation and at high risk for stroke. Circulation. 2016; 134:A17636.
  2. McDonald A, et al. Increasing US emergency department visit rates and subsequent hospital admissions for atrial fibrillation from 1993-2004. Ann Emerg Med. 2008;51:58-65.
  3. Dlott J, et al. National assessment of warfarin anticoagulation therapy for stroke prevention in atrial fibrillation. Circulation. 2014;129:1407-1414.
  4. Johnson B, et al. Readmission among hospitalized patients with non valvular atrial fibrillation. Am J Health Syst Pharm. 2013; 70(5):414-422.
  5. Kim MH, et al. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. 2011;4(3):313-320.
  6. Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace 2010;12:1360–1420.
  7. Xian Y, et al. Association of preceding antithrombotic treatment with acute ischemic stroke severity and in-hospital outcomes among patients with atrial fibrillation. JAMA. 2017;317(10):1057-1067.

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