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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODAFL0001 | Other Identifier | Janssen Scientific Affairs, LLC |
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Operating Company decided to stop study due to strategic realignment and budgetary reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Thunderbird | Glendale | Arizona | 85306 | United States | ||
| Banner Desert Medical Center |
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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) |
| Mesa |
| Arizona |
| 85202 |
| United States |
| Banner Baywood Medical Center | Mesa | Arizona | 85206 | United States |
| Banner Heart Hospital | Mesa | Arizona | 85206 | United States |
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States |
| Banner Estrella | Phoenix | Arizona | 85037 | United States |
| Banner Boswell Medical Center | Sun City | Arizona | 85351 | United States |
| Banner Del Webb | Sun City West | Arizona | 85375 | United States |
| Banner University Medical Center - South (BUMC-S) | Tucson | Arizona | 85713 | United States |
| Banner University Medical Center - Tucson (BUMC-T) | Tucson | Arizona | 85724 | United States |
| Banner North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| AMITA Adventist Medical Center Bolingbrook | Bolingbrook | Illinois | 60440 | United States |
| AMITA Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| AMITA Adventist Medical Center Hinsdale | Hinsdale | Illinois | 60521 | United States |
| AMITA St. Alexius Medical Center | Hoffman Estates | Illinois | 60169 | United States |
| AMITA Adventist Medical Center La Grange | La Grange | Illinois | 60525 | United States |
| SSM Health Good Samaritan Hospital | Mount Vernon | Illinois | 62864 | United States |
| Ephraim McDowell Regional Medical Center | Danville | Kentucky | 40422 | United States |
| St. Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | United States |
| Fremont Health Medical Center | Fremont | Nebraska | 68025 | United States |
| Penn Medicine - Princeton Health | Plainsboro | New Jersey | 08536 | United States |
| AtlantiCare | Pomona | New Jersey | 08240 | United States |
| Southside Hospital | Bay Shore | New York | 11706 | United States |
| Our Lady of Lourdes Hospital | Binghamton | New York | 13905 | United States |
| Long Island Jewish Forest Hills | Forest Hills | New York | 11375 | United States |
| Huntington Hospital | Huntington | New York | 11743 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Long Island Jewish Med Ctr | New Hyde Park | New York | 11040 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| Long Island Jewish Valley Stream | Valley Stream | New York | 11580 | United States |
| Samaritan Medical Center | Watertown | New York | 13601 | United States |
| The Jewish Hospital - Mercy | Cincinnati | Ohio | 45236 | United States |
| Mercy Anderson Hospital | Cincinnati | Ohio | 45255 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Mercy St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Mercy Lorain Regional Medical Center | Lorain | Ohio | 44053 | United States |
| Mercy St. Charles Hospital | Oregon | Ohio | 43616 | United States |
| University Hospitals Regional Hospitals | Richmond Heights | Ohio | 44143 | United States |
| Mercy Health St Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Mercy St. Anne Hospital | Toledo | Ohio | 43623 | United States |
| Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Saint Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| St. Luke's University Health Network | Allentown | Pennsylvania | 18102 | United States |
| St.Luke's University Health Network - St.Luke's Cardiology Associates | Bethlehem | Pennsylvania | 18015 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Geisinger Medical Center | Scranton | Pennsylvania | 18510 | United States |
| Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania | 18711 | United States |
| AnMed Health | Anderson | South Carolina | 29621 | United States |
| Avera McKennan Hospital | Sioux Falls | South Dakota | 57105 | United States |
| Hendrick Medical Center | Abilene | Texas | 79601 | United States |
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Methodist Charlton Medical Center | Dallas | Texas | 75237 | United States |
| Methodist Mansfield Medical Center | Mansfield | Texas | 76063 | United States |
| Methodist Richardson Medical Center | Richardson | Texas | 75082 | United States |
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | United States |
| Inova Health Care Services | Falls Church | Virginia | 22042 | United States |
| Riverside Regional Medical Center | Newport News | Virginia | 23601 | United States |
| St Marys Medical Center | Huntington | West Virginia | 25702 | United States |
| Monongalia County General Hospital Company | Morgantown | West Virginia | 26505 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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