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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04059965
Other study ID # P0534218
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date September 30, 2025

Study information

Verified date August 2022
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn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

Study Design


Intervention

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
Usual Care
Patients will receive standard, protocolized care in their respective anticoagulation clinics

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Outcome

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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