ACTIVE: AntiCoagulation Tracking InterVention and Evaluation

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04059965

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation Atrial Fibrillation Atrial Flutter Pulmonary Embolus/Emboli Deep Vein Thrombosis Stroke Hypercoagulability	Other: Panel Management for Anticoagulation Therapy Other: Usual Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm 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 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
Active Comparator: Control Arm This cohort of patients will receive usual care	Other: Usual Care Patients will receive standard, protocolized care in their respective anticoagulation clinics

Arm

Intervention/Treatment

Experimental: Intervention Arm

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

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

Active Comparator: Control Arm

This cohort of patients will receive usual care

Other: Usual Care

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

Outcome Measures

Primary Outcome Measures

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

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)

Other Outcome Measures

Time from out-of-range to patient contact (T2C) [Study Period (average of 2 years)]
Time it takes clinicians to respond to abnormal test results
Adherence to monitoring guidelines [Study Period (average of 2 years)]
Proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines
Attendance/ no-show rate [Study Period (average of 2 years)]
Rate of missed appointments
Timely discontinuation of treatment [Study Period (average of 2 years)]
Timeliness of treatment duration assessed as percentage of time on therapy in excess of what was prescribed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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