Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
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|ClinicalTrials.gov Identifier: NCT02392104|
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : November 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Anticoagulation||Drug: Warfarin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service|
|Actual Study Start Date :||March 27, 2015|
|Actual Primary Completion Date :||June 25, 2017|
|Actual Study Completion Date :||June 25, 2017|
Experimental: Intervention Arm
All patients in the study will be in the intervention arm.
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.
- Rates of participant accrual [ Time Frame: up to 2.25 years ]Number of participants who enroll vs. number of individuals invited
- Change in frequency of appointments from baseline to end of study [ Time Frame: up to 2 years ]
- Bleeding and thromboembolic events from baseline [ Time Frame: 6, 12, and 24 months ]
- Time in therapeutic range from baseline [ Time Frame: 6, 12, and 24 months ]
- Patient satisfaction [ Time Frame: baseline, 6 months, 12 months, 24 months ]
- Frequency and type of protocol deviations from both participants and study staff [ Time Frame: Up to 2.25 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392104
|Principal Investigator:||Carla Staresinic, PharmD, BCACP||William S. Middleton Memorial Veterans Hospital|