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Anticoagulants are a leading cause of acute injury from adverse drug events, leading to ~20,000 serious injuries reported to the Food and Drug Administration per year and more than 220,000 emergency department visits annually. Therefore, we propose to implement a health information technology (HIT) population management tool at two distinct anticoagulation clinics that will allow the care team to assign and track tasks essential for timely patient monitoring. We will examine its effect on anticoagulation management outcomes through a randomized trial, hypothesizing that such interventions can be effective as well as cost-effective strategies to improve patient safety in the context of anticoagulation management services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | This cohort of patients will receive panel management through a customize software that integrates with the electronic health record |
|
| Control Arm | Active Comparator | This cohort of patients will receive usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panel Management for Anticoagulation Therapy | Other | Patients in the intervention arm will receive notifications reminding them of upcoming labs and appointments. We hypothesize this will improve adherence and therapeutic control and reduce risk for bleeds and/or strokes |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Therapeutic Range | Using the Rosendaal method, we will assess the proportion of the treatment duration that the patient's International Normalized Ratio is within the goal therapeutic range. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Time in Range | Simple ratio of proportion of time patient's International Normalized Ratio is in goal range. | 6 months |
| Time from initiation to therapeutic INR (TWTR) | Time to achieve first therapeutic international normalized ratio |
| Measure | Description | Time Frame |
|---|---|---|
| Time from out-of-range to patient contact (T2C) | Time it takes clinicians to respond to abnormal test results | Study Period (average of 2 years) |
| Adherence to monitoring guidelines | Proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urmimala Sarkar, MD, MPH | University of California, San Francisco | Principal Investigator |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D011655 | Pulmonary Embolism |
| D004617 | Embolism |
| D020246 | Venous Thrombosis |
| D020521 | Stroke |
| D019851 | Thrombophilia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Usual Care | Other | Patients will receive standard, protocolized care in their respective anticoagulation clinics |
|
| Study Period (average of 2 years) |
| Adverse events | Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke) | Study Period (average of 2 years) |
| Study Period (average of 2 years) |
| Attendance/ no-show rate | Rate of missed appointments | Study Period (average of 2 years) |
| Timely discontinuation of treatment | Timeliness of treatment duration assessed as percentage of time on therapy in excess of what was prescribed | Study Period (average of 2 years) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D013927 | Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |