AntiCoagulation Tracking InterVention and Evaluation

Stroke Clinical Trial

— ACTIVE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04059965
• Other study ID #: P0534218
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation
• Atrial Fibrillation
• Atrial Flutter
• Deep Vein Thrombosis
• Embolism
• Hypercoagulability
• Pulmonary Embolism
• Pulmonary Embolus/Emboli
• Stroke
• Thrombophilia
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Panel Management for Anticoagulation Therapy
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 Care
Patients will receive standard, protocolized care in their respective anticoagulation clinics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Adherence to monitoring guidelines	Proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines	Study Period (average of 2 years)
Other	Attendance/ no-show rate	Rate of missed appointments	Study Period (average of 2 years)
Other	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)
Primary	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	Proportion Time in Range	Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.	6 months
Secondary	Time from initiation to therapeutic INR (TWTR)	Time to achieve first therapeutic international normalized ratio	Study Period (average of 2 years)
Secondary	Adverse events	Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)	Study Period (average of 2 years)