N/A
Completed N=50
Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
Anticoagulation
Source: ClinicalTrials.gov NCT02392104 ↗
Enrolled (actual)
50
Serious AEs
30.0%
Results posted
Dec 2019
Primary outcomePrimary: Rates of Participant Accrual — 107; 51; 50 Participants
Summary
The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.
All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol. Patient satisfaction will be evaluated at various points throughout the study. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Participant Accrual |
107; 51; 50 | — |
| PRIMARY Number of Participants Able to be Scheduled for at Least One 12-week Interval |
36 | — |
| PRIMARY Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals |
15 | — |
| SECONDARY Change in Frequency of Appointments From Baseline to End of Study |
12.67; 10.43 | — |
| SECONDARY Bleeding and Thromboembolic Events From Baseline |
2; 6; 16 | — |
| SECONDARY Change in Time in Therapeutic Range From Baseline |
-12.2; -7.3; -4.4 | — |
| SECONDARY Patient Satisfaction Through Total DASS Score |
42.89; 43.99; 38.83; 46.82 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- requirement for indefinite warfarin therapy
- target INR of 2-3
- stable weekly warfarin dose for the past 6 months (not more than a single, one-time adjustment (boost/omission) in the past 6 months, planned interruption for a procedure or surgery with INR(s) out of range in the past 6 months would not exclude a patient)
- a patient of the Madison VA anticoagulation clinic for the previous 12 months
Exclusion Criteria
- consistently drink ≥4 alcoholic beverages/day or a documented episode of alcohol binging in the past 6 months
- diagnosis of cancer and on active chemotherapy/radiotherapy in the past 3 months
- life expectancy of < 1 year
- enrolled in other investigational drug protocols
- only receiving anticoagulation care at the Madison VA for part of the year (e.g. snowbirds)
- receiving visiting nurse services for INR monitoring
- thrombocytopenia (<100K) within past 12 months
- history of bleeding or thromboembolism requiring medical intervention within past 6 months
- treatment for active liver disease (e.g. hepatitis)
- diagnosis or documentation in EMR suggesting cognitive impairment
- activated power of attorney
- inability to provide informed consent
- non-English speaking
- unstable mental health disorder that impairs judgment
- history of non-adherence to anticoagulation clinic policies and procedures (i.e. missed appointments, self-adjustment of warfarin dose, nonadherence, etc.).
Data sourced from ClinicalTrials.gov (NCT02392104). 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. Informational only — not medical advice.