N/A
N=1,260,576
Improving Anticoagulation Control in VISN 1
Anticoagulants · Atrial Fibrillation · Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT01653405 ↗Enrolled (actual)
1,260,576
Serious AEs
—
Results posted
Apr 2019
Primary outcome: Primary: Percent Change in Time in Therapeutic Range (TTR) — 2.8; 0.5 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multifaceted behavioral intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Time in Therapeutic Range (TTR) |
2.8; 0.5 | <0.001 sig |
| SECONDARY Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin |
-0.03; -0.01 | 0.43 |
| SECONDARY Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0) |
15; 0 | <0.001 sig |
| SECONDARY Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower) |
15; 2 | <0.001 sig |
| SECONDARY Percentage of Patients With Mean INR Value Between 2.3 - 2.7 |
6; 1 | 0.002 sig |
Summary
Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood clots (including strokes). Too much anticoagulation increases the risk of serious or even fatal bleeding, and too little anticoagulation fails to protect the patient against blood clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the therapeutic range, the range within which they are protected from clots but not at excessive risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following several relatively simple procedures, including following-up promptly when patients are out of range and focusing on educating and supporting patients with poor control. In this study, the investigators will promote these practices at the anticoagulation clinics of the New England VA region, with a goal of improving anticoagulation control.
Eligibility Criteria
Inclusion Criteria
- All patients receiving long-term oral anticoagulation with warfarin within the VA New England Region ("VISN 1")
Exclusion Criteria
- Patients with valvular heart disease, who may have an INR target range other than 2-3. This usually represents between 10-15% of patients receiving anticoagulation.
Data sourced from ClinicalTrials.gov (NCT01653405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.