Stroke Clinical Trial
— ACTIVEOfficial title:
AntiCoagulation Tracking InterVention and Evaluation: Using a Customized Panel Management Platform to Improve Outcomes for Patients on Anticoagulation
Verified date | August 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time from out-of-range to patient contact (T2C) | Time it takes clinicians to respond to abnormal test results | Study Period (average of 2 years) | |
Other | Adherence to monitoring guidelines | Proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines | Study Period (average of 2 years) | |
Other | Attendance/ no-show rate | Rate of missed appointments | Study Period (average of 2 years) | |
Other | Timely discontinuation of treatment | Timeliness of treatment duration assessed as percentage of time on therapy in excess of what was prescribed | Study Period (average of 2 years) | |
Primary | 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. | 6 months | |
Secondary | Proportion Time in Range | Simple ratio of proportion of time patient's International Normalized Ratio is in goal range. | 6 months | |
Secondary | Time from initiation to therapeutic INR (TWTR) | Time to achieve first therapeutic international normalized ratio | Study Period (average of 2 years) | |
Secondary | Adverse events | Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke) | Study Period (average of 2 years) |
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