AntiCoagulation Tracking InterVention and Evaluation

NCT ID: NCT04059965

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Arm

This cohort of patients will receive panel management through a customize software that integrates with the electronic health record

Group Type: EXPERIMENTAL

Panel Management for Anticoagulation Therapy

Intervention Type: OTHER

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

Control Arm

This cohort of patients will receive usual care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urmimala Sarkar, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

P0534218

Identifier Type: -

Identifier Source: org_study_id