AntiCoagulation Tracking InterVention and Evaluation (ACTIVE)

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

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 Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Attendance/ no-show rate	Rate of missed appointments	Study Period (average of 2 years)
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)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Urmimala Sarkar, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Thrombosis; Venous Thrombosis; Atrial Flutter; Pulmonary Embolism; Thrombophilia
• Other Study ID Numbers: P0534218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No