ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CR108407
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03382613
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Atrial Fibrillation

Study Type : Observational
Estimated Enrollment : 3733 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantify Use of Anticoagulation to Improve Management of AF
Actual Study Start Date : December 29, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods [ Time Frame: 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 :
  1. Percentage of Patients Readmitted to the Same Hospital [ Time Frame: 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.

  2. Percentage of Patients who Received OAC by Hospital Characteristics Subgroups [ Time Frame: 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.

  3. Effect of Tools Components of the QI Program on the use of OAC [ Time Frame: 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.

  4. Effect of Degree of Engagement in the QI Program [ Time Frame: End of study (Month 20) ]
    A performance dashboard will be implemented to aggregate and display performance data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382613


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Show 49 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC

Additional Information:
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT03382613     History of Changes
Other Study ID Numbers: CR108407
NOPRODAFL0001 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes