AntiCoagulation Tracking InterVention and Evaluation

Not Applicable

Withdrawn

• Conditions: Hypercoagulability; Deep Vein Thrombosis; Stroke; Pulmonary Embolus/Emboli; Anticoagulation; Atrial Fibrillation; Atrial Flutter
• Interventions: Other: Panel Management for Anticoagulation Therapy; Other: Usual Care

• Registration Number: NCT04059965
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Study Start: 2022-10-01
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults (age ≥18 years)
• those prescribed an anticoagulation medication at Zuckerberg San Francisco General Hospital or University of California, San Francisco Health

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Exclusion Criteria

• Minors (age<18)
• those not prescribed anticoagulation medication at ZSFG or UCSF Health

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Panel Management for Anticoagulation Therapy	This cohort of patients will receive panel management through a customize software that integrates with the electronic health record
Control Arm	Usual Care	This cohort of patients will receive usual care

Primary Outcome Measures

Name	Time	Method
Time in Therapeutic Range	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion Time in Range	6 months	Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.
Time from initiation to therapeutic INR (TWTR)	Study Period (average of 2 years)	Time to achieve first therapeutic international normalized ratio
Adverse events	Study Period (average of 2 years)	Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)