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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 : August 16, 2019
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The overarching goal of this project is to assess the impact and cost-effectiveness of system-level and patient-facing interventions on anticoagulation treatment and characterize the current state of safety for Direct Oral Anticoagulants (DOACs). The investigators focus on examining implementation factors and cost-effectiveness, which are critical to helping health care decision-makers prioritize finite resources, particularly in safety-net health systems where a disproportionate number of Agency for Healthcare Research and Quality's Priority Populations—low-income and racial/ ethnic minority groups—receive care. Therefore, the investigators propose to implement an Health Information Technology (HIT) population management tool with patient-facing outreach and team-based workflow, the AntiCoagulation Tracking InterVention and Evaluation (ACTIVE), and examine its effect on anticoagulation management outcomes in two diverse settings - a safety net hospital and a large academic medical center - hypothesizing that such interventions can be cost-effective strategies to improve patient safety.

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 : 950 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 : April 1, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2023

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 ]

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

  2. Time from initiation to therapeutic INR (TWTR) [ Time Frame: 6 months ]
    time to achieve first therapeutic international normalized ratio

  3. Adverse events (bleeds, deep vein thrombosis/pulmonary embolism, stroke) [ Time Frame: through study completion, an average of 2 years ]
    bleeds, strokes, pulmonary embolism, deep vein thrombosis

Other Outcome Measures:
  1. Timely discontinuation of treatment [ Time Frame: through study completion, an average of 2 years ]
    timeliness of treatment duration assessed as percentage of time on therapy in excess of what was prescribed

  2. Attendance/No-Show Rate [ Time Frame: through study completion, an average of 1 year ]
    rate of missed appointments

  3. Adherence to monitoring guidelines [ Time Frame: through study completion, an average of 1 year ]
    proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines

  4. Time from out-of-range to patient contact (T2C) [ Time Frame: through study completion, an average of 1 year ]
    time it takes clinicians to respond to abnormal test results

Information from the National Library of Medicine

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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: Gato Gourley, MSc 415-206-5277

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     History of Changes
Other Study ID Numbers: P0534218
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
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