AnticoagulationNCT02392104
Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
A study testing Warfarin in people with Anticoagulation, run by William S. Middleton Memorial Veterans Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- What is being tested?
- Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2015to 25 Jun 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.).
About this study
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.
Read the 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.
- Conditions
- Anticoagulation
- Being tested
- Warfarin
- Keywords
- International Normalized Ratio, Warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Coumadin
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | All patients in the study will be in the intervention arm. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Participant Accrual
Number of participants who enroll vs. number of individuals invited
Measured: up to 2.25 years
Number of Participants Able to be Scheduled for at Least One 12-week Interval
This outcome will determine the number of participants able to be scheduled for at least one 12-week interval
Measured: 24 months
Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals
The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals
Measured: 24 months
Secondary outcomes (4)
Change in Frequency of Appointments From Baseline to End of Study
This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)
Measured: 12 and 24 months
Bleeding and Thromboembolic Events From Baseline
This outcome will determine the number of bleeding and thromboembolic events from baseline
Measured: 24 months
Change in Time in Therapeutic Range From Baseline
The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)
Measured: 6, 12, and 24 months
Patient Satisfaction Through Total DASS Score
Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale ("not at all" = 1, "very much" = 7).
Measured: baseline, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start27 Mar 2015
- Primary completion25 Jun 2017
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- William S. Middleton Memorial Veterans Hospital
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Carla Staresinic, William S. Middleton Memorial Veterans Hospital
- Investigators
- Carla Staresinic, PharmD, Principal investigator, William S. Middleton Memorial Veterans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392104
- Sponsor's protocol ID
- 2014-1296
- Status last verified
- Nov 2019
- First submitted
- 25 Feb 2015
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 31752504