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Withdrawn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
About this trial
This is an interventional treatment trial for Anticoagulation
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
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
NCT ID
NCT04059965
First Posted
May 27, 2019
Last Updated
August 2, 2022
Sponsor
University of California, San Francisco
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Withdrawn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
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