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

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT03382613

CR108407

NOPRODAFL0001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,000 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Quality Improvement (QI) Program

Description:

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

Description:

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.