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
Results First Posted : December 11, 2019
Last Update Posted : December 11, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | February 25, 2015 | |||
First Posted Date ICMJE | March 18, 2015 | |||
Results First Submitted Date ICMJE | October 16, 2019 | |||
Results First Posted Date ICMJE | December 11, 2019 | |||
Last Update Posted Date | December 11, 2019 | |||
Actual Study Start Date ICMJE | March 27, 2015 | |||
Actual Primary Completion Date | June 25, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Rates of Participant Accrual [ Time Frame: up to 2.25 years ] Number of withdrawals and reasons for withdrawal from protocol or study
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Frequency and Type of Protocol Deviations From Both Participants and Study Staff [ Time Frame: Up to 2.25 years ] This outcome determines the frequency and type of protocol deviations from both participants and study staff
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | ||||
Brief Title ICMJE | Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service | |||
Official Title ICMJE | Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service | |||
Brief 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. |
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Detailed Description | 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, 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Anticoagulation | |||
Intervention ICMJE | Drug: 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 Name: Coumadin
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Study Arms ICMJE | Experimental: Intervention Arm
All patients in the study will be in the intervention arm.
Intervention: Drug: Warfarin
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
51 | |||
Original Estimated Enrollment ICMJE |
75 | |||
Actual Study Completion Date ICMJE | June 25, 2017 | |||
Actual Primary Completion Date | June 25, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02392104 | |||
Other Study ID Numbers ICMJE | 2014-1296 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Carla Staresinic, William S. Middleton Memorial Veterans Hospital | |||
Study Sponsor ICMJE | William S. Middleton Memorial Veterans Hospital | |||
Collaborators ICMJE | University of Wisconsin, Madison | |||
Investigators ICMJE |
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PRS Account | William S. Middleton Memorial Veterans Hospital | |||
Verification Date | November 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |