AntiCoagulation Tracking InterVention and Evaluation

University of California, San Francisco

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

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

Interventions

Panel Management for Anticoagulation TherapyOTHER

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

Usual CareOTHER

Patients will receive standard, protocolized care in their respective anticoagulation clinics

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Proportion Time in Range

Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.

Time frame: 6 months

Time from initiation to therapeutic INR (TWTR)

Time to achieve first therapeutic international normalized ratio

Time frame: Study Period (average of 2 years)

Adverse events

Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)

Time frame: Study Period (average of 2 years)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.