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 : May 31, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3733 participants|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
Show 27 Study Locations
|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|