Anticoagulation, Atrial Fibrillation, Atrial Flutter, Deep Vein Thrombosis, Hypercoagulability, Pulmonary Embolus/Emboli, Stroke
Conditions
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.
Interventions
OTHERPanel 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
OTHERUsual Care
Patients will receive standard, protocolized care in their respective anticoagulation clinics
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Therapeutic Range | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Study Period (average of 2 years) | Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke) |
| Proportion Time in Range | 6 months | Simple ratio of proportion of time patient's International Normalized Ratio is in goal range. |
| Time from initiation to therapeutic INR (TWTR) | Study Period (average of 2 years) | Time to achieve first therapeutic international normalized ratio |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time from out-of-range to patient contact (T2C) | Study Period (average of 2 years) | Time it takes clinicians to respond to abnormal test results |
| Adherence to monitoring guidelines | Study Period (average of 2 years) | Proportion of patients who receive follow-up in a timely manner as defined by treatment guidelines |
| Attendance/ no-show rate | Study Period (average of 2 years) | Rate of missed appointments |
| Timely discontinuation of treatment | Study Period (average of 2 years) | Timeliness of treatment duration assessed as percentage of time on therapy in excess of what was prescribed |
Outcome results
None listed