Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
NCT ID: NCT02392104
Last Updated: 2019-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2015-03-27
2017-06-25
Brief Summary
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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.
Detailed Description
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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, from 5-6 weeks, to 7-8 weeks, to 11-12 weeks and then continued with 11-12 week visits if INRs continue to remain in goal range and appropriate for the patient. Patient satisfaction will be evaluated at baseline, 6-, 12-, and 24-months. 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention Arm
All patients in the study will be in the intervention arm.
Warfarin
If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.
Interventions
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Warfarin
If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
William S. Middleton Memorial Veterans Hospital
FED
Responsible Party
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Carla Staresinic
Manager, Anticoagulation Services
Principal Investigators
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Carla Staresinic, PharmD
Role: PRINCIPAL_INVESTIGATOR
William S. Middleton Memorial Veterans Hospital
References
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Schoen RR, Nagy MW, Porter AL, Margolis AR. Patient Satisfaction With Extended International Normalized Ratio Follow-up Intervals in a Veteran Population. Ann Pharmacother. 2020 May;54(5):442-449. doi: 10.1177/1060028019889414. Epub 2019 Nov 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-1296
Identifier Type: -
Identifier Source: org_study_id