Anticoagulation, Thromboembolism
Conditions
Brief summary
Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care? Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of time the INR is within target range will be compared between the two groups. Thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.
Interventions
PROCEDUREmedical care delivery model
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* completion of \>3 months of warfarin * indefinite warfarin therapy
Exclusion criteria
* patients who currently receive \>25% of INR determinations per year from local labs * extended absences from VA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent time in therapeutic range (TTR) using modified version of Rosendaal method | — |
Secondary
| Measure | Time frame |
|---|---|
| Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life | — |
Countries
United States
Outcome results
None listed