AntiCoagulation Tracking InterVention and Evaluation

NCT04059965 | Withdrawn

• 1 other identifier: P0534218
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion Time in Range

  6 months

• Time from initiation to therapeutic INR (TWTR)

  Study Period (average of 2 years)

• Adverse events

  Study Period (average of 2 years)

Other Outcomes (4)

• Time from out-of-range to patient contact (T2C)

  Study Period (average of 2 years)

• Adherence to monitoring guidelines

  Study Period (average of 2 years)

• Attendance/ no-show rate

  Study Period (average of 2 years)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

ACTIVE COMPARATOR

This cohort of patients will receive usual care

Other: Usual Care

Interventions

Panel Management for Anticoagulation Therapy 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

Intervention Arm

Usual Care OTHER

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Pulmonary Embolism; Embolism; Venous Thrombosis; Stroke; Thrombophilia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Urmimala Sarkar, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: August 16, 2019
• Study Start: October 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share