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AntiCoagulation Tracking InterVention and Evaluation (ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04059965
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : January 13, 2021
Information provided by (Responsible Party):
University of California, San Francisco

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 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
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024

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

Primary Outcome Measures :
  1. Time in Therapeutic Range [ Time Frame: 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 :
  1. Proportion Time in Range [ Time Frame: 6 months ]
    Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.

  2. Time from initiation to therapeutic INR (TWTR) [ Time Frame: Study Period (average of 2 years) ]
    Time to achieve first therapeutic international normalized ratio

  3. Adverse events [ Time Frame: Study Period (average of 2 years) ]
    Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)

Other Outcome Measures:
  1. Time from out-of-range to patient contact (T2C) [ Time Frame: Study Period (average of 2 years) ]
    Time it takes clinicians to respond to abnormal test results

  2. Adherence to monitoring guidelines [ Time Frame: Study Period (average of 2 years) ]
    Proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines

  3. Attendance/ no-show rate [ Time Frame: Study Period (average of 2 years) ]
    Rate of missed appointments

  4. Timely discontinuation of treatment [ Time Frame: Study Period (average of 2 years) ]
    Timeliness of treatment duration assessed as percentage of time on therapy in excess of what was prescribed

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04059965

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Contact: Urmimala Sarkar, MD, MPH 415-206-4273
Contact: Sarah Lisker 628-206-6609

Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Urmimala Sarkar, MD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT04059965    
Other Study ID Numbers: P0534218
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Atrial Fibrillation
Venous Thrombosis
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Hematologic Diseases
Lung Diseases
Respiratory Tract Diseases