- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059965
AntiCoagulation Tracking InterVention and Evaluation (ACTIVE)
August 2, 2022 updated by: University of California, San Francisco
AntiCoagulation Tracking InterVention and Evaluation: Using a Customized Panel Management Platform to Improve Outcomes for Patients on Anticoagulation
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
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
|
Patients will receive standard, protocolized care in their respective anticoagulation clinics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion Time in Range
Time Frame: 6 months
|
Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.
|
6 months
|
Time from initiation to therapeutic INR (TWTR)
Time Frame: Study Period (average of 2 years)
|
Time to achieve first therapeutic international normalized ratio
|
Study Period (average of 2 years)
|
Adverse events
Time Frame: Study Period (average of 2 years)
|
Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)
|
Study Period (average of 2 years)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Study Period (average of 2 years)
|
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
|
Study Period (average of 2 years)
|
Attendance/ no-show rate
Time Frame: Study Period (average of 2 years)
|
Rate of missed appointments
|
Study Period (average of 2 years)
|
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
|
Study Period (average of 2 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Urmimala Sarkar, MD, MPH, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2022
Primary Completion (Anticipated)
September 30, 2024
Study Completion (Anticipated)
September 30, 2025
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
August 15, 2019
First Posted (Actual)
August 16, 2019
Study Record Updates
Last Update Posted (Actual)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0534218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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