AntiCoagulation Tracking InterVention and Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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AntiCoagulation Tracking InterVention and Evaluation: Using a Customized Panel Management Platform to Improve Outcomes for Patients on Anticoagulation

Conditions
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Pulmonary Embolus/Emboli, Anticoagulation, Atrial Fibrillation, Atrial Flutter, Deep Vein Thrombosis, Stroke, Hypercoagulability

Intervention / Treatment
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* Other: Panel Management for Anticoagulation Therapy
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age ≥18 years) those prescribed an anticoagulation medication at Zuckerberg San Francisco General Hospital or University of California, San Francisco Health Exclusion Criteria: Minors (age<18) those not prescribed anticoagulation medication at ZSFG or UCSF Health

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>This cohort of patients will receive panel management through a customize software that integrates with the electronic health record | Other: Panel Management for Anticoagulation Therapy<br>* 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<br>|
| Active Comparator: Control Arm<br>This cohort of patients will receive usual care | Other: Usual Care<br>* Patients will receive standard, protocolized care in their respective anticoagulation clinics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Study Period (average of 2 years) | 
| Adverse events | Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke) | Study Period (average of 2 years) |