Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service

Anticoagulation Clinical Trial

Official title:

Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392104
• Other study ID #: 2014-1296
• Status: Completed
• Phase: N/A
• Start date: March 27, 2015
• Est. completion date: June 25, 2017

Study information

• Verified date: November 2019
• Source: William S. Middleton Memorial Veterans Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 25, 2017
• Est. primary completion date: June 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Anticoagulation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
William S. Middleton Memorial Veterans Hospital	University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency and Type of Protocol Deviations From Both Participants and Study Staff	This outcome determines the frequency and type of protocol deviations from both participants and study staff	Up to 2.25 years
Primary	Rates of Participant Accrual	Number of participants who enroll vs. number of individuals invited	up to 2.25 years
Primary	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	24 months
Primary	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	24 months
Secondary	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)	12 and 24 months
Secondary	Bleeding and Thromboembolic Events From Baseline	This outcome will determine the number of bleeding and thromboembolic events from baseline	24 months
Secondary	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)	6, 12, and 24 months
Secondary	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).	baseline, 6 months, 12 months, 24 months