search
Back to results

AntiCoagulation Tracking InterVention and Evaluation (ACTIVE)

Primary Purpose

Anticoagulation, Atrial Fibrillation, Atrial Flutter

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Panel Management for Anticoagulation Therapy
Usual Care
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anticoagulation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Arm

    Control Arm

    Arm Description

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

    This cohort of patients will receive usual care

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Proportion Time in Range
    Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.
    Time from initiation to therapeutic INR (TWTR)
    Time to achieve first therapeutic international normalized ratio
    Adverse events
    Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)

    Full Information

    First Posted
    May 27, 2019
    Last Updated
    August 2, 2022
    Sponsor
    University of California, San Francisco
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04059965
    Brief Title
    AntiCoagulation Tracking InterVention and Evaluation
    Acronym
    ACTIVE
    Official Title
    AntiCoagulation Tracking InterVention and Evaluation: Using a Customized Panel Management Platform to Improve Outcomes for Patients on Anticoagulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anticoagulation, Atrial Fibrillation, Atrial Flutter, Pulmonary Embolus/Emboli, Deep Vein Thrombosis, Stroke, Hypercoagulability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    This cohort of patients will receive panel management through a customize software that integrates with the electronic health record
    Arm Title
    Control Arm
    Arm Type
    Active Comparator
    Arm Description
    This cohort of patients will receive usual care
    Intervention Type
    Other
    Intervention Name(s)
    Panel Management for Anticoagulation Therapy
    Intervention Description
    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
    Intervention Name(s)
    Usual Care
    Intervention Description
    Patients will receive standard, protocolized care in their respective anticoagulation clinics
    Primary Outcome Measure Information:
    Title
    Time in Therapeutic Range
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Proportion Time in Range
    Description
    Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.
    Time Frame
    6 months
    Title
    Time from initiation to therapeutic INR (TWTR)
    Description
    Time to achieve first therapeutic international normalized ratio
    Time Frame
    Study Period (average of 2 years)
    Title
    Adverse events
    Description
    Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)
    Time Frame
    Study Period (average of 2 years)
    Other Pre-specified Outcome Measures:
    Title
    Time from out-of-range to patient contact (T2C)
    Description
    Time it takes clinicians to respond to abnormal test results
    Time Frame
    Study Period (average of 2 years)
    Title
    Adherence to monitoring guidelines
    Description
    Proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines
    Time Frame
    Study Period (average of 2 years)
    Title
    Attendance/ no-show rate
    Description
    Rate of missed appointments
    Time Frame
    Study Period (average of 2 years)
    Title
    Timely discontinuation of treatment
    Description
    Timeliness of treatment duration assessed as percentage of time on therapy in excess of what was prescribed
    Time Frame
    Study Period (average of 2 years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Urmimala Sarkar, MD, MPH
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    AntiCoagulation Tracking InterVention and Evaluation

    We'll reach out to this number within 24 hrs