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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Daiichi Sankyo | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
| Bayer |
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To determine whether a comprehensive evaluation and customized multilevel educational interventions will increase the rate of use of oral anticoagulants and the adherence and persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be differences in the use of oral anticoagulants and the persistence in patients between the control and interventional group. There will be a greater change in the use of oral anticoagulants over one year in the cohort in the intervention sites than the control sites. This will be due to two factors: greater initiation of oral anticoagulants among patients not treated at baseline and greater persistence of treatment for those on treatment at baseline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | educational intervention arm |
|
| control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in proportion of patients taking oral anticoagulants | Change in proportion of patients taking oral anticoagulants from baseline to one year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in proportion of patients able to continue anticoagulation | Change in proportion of patients able to continue anticoagulation for one year | 1 year |
| Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Embolism | 1 year | |
| Transient Ischemic Attack | 1 year | |
| Hospitalizations for cardiovascular causes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher B Granger, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INECO Neurosciencias Orono | Rosario | Santa Fe Province | Argentina | |||
| Federal University of Sao Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28859942 | Derived | Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28. | |
| 27264227 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| INDUSTRY |
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Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation at one year |
| 1 year |
| Death, total | 1 year |
| Stroke, hemorrhagic and non-hemorrhagic | 1 year |
| Major and non-major clinically relevant bleeding | 1 year |
| 1 year |
| Time in therapeutic range for patients on vitamin K antagonists (VKA) | 1 year |
| São Paulo |
| Brazil |
| Peking University First Hospital | Beijing | China |
| St Johns Medical College | Bangalore | India |
| University of Medicina and Pharmacy Carol Davila | Bucharest | Romania |
| Derived |
| Rao MP, Ciobanu AO, Lopes RD, Fox KA, Xian Y, Pokorney SD, Al-Khalidi HR, Jiang J, Kamath DY, Berwanger O, Xavier D, Bahit CM, Tajer C, Vinereanu D, Huo Y, Granger CB. A clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AF): design and rationale. Am Heart J. 2016 Jun;176:107-13. doi: 10.1016/j.ahj.2016.03.011. Epub 2016 Mar 21. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011314 | Preventive Health Services |