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

• ClinicalTrials.gov Identifier: NCT02392104
• Recruitment Status: Completed
• First Posted: March 18, 2015
• Results First Posted: December 11, 2019
• Last Update Posted: December 11, 2019
• Sponsor: William S. Middleton Memorial Veterans Hospital
• Collaborator: University of Wisconsin, Madison
• Information provided by (Responsible Party): Carla Staresinic, William S. Middleton Memorial Veterans Hospital

Tracking Information

• First Submitted Date: February 25, 2015
• First Posted Date: March 18, 2015
• Results First Submitted Date: October 16, 2019
• Results First Posted Date: December 11, 2019
• Last Update Posted Date: December 11, 2019
• Actual Study Start Date: March 27, 2015
• Actual Primary Completion Date: June 25, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2019)

• Rates of Participant Accrual [ Time Frame: up to 2.25 years ]
  Number of participants who enroll vs. number of individuals invited
• Number of Participants Able to be Scheduled for at Least One 12-week Interval [ Time Frame: 24 months ]
  This outcome will determine the number of participants able to be scheduled for at least one 12-week interval
• Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals [ Time Frame: 24 months ]
  The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals

Original Primary Outcome Measures (submitted: March 17, 2015)

Rates of Participant Accrual [ Time Frame: up to 2.25 years ]

Number of withdrawals and reasons for withdrawal from protocol or study

• Change History: Complete list of historical versions of study NCT02392104 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 21, 2019)

• Change in Frequency of Appointments From Baseline to End of Study [ Time Frame: 12 and 24 months ]
  This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)
• Bleeding and Thromboembolic Events From Baseline [ Time Frame: 24 months ]
  This outcome will determine the number of bleeding and thromboembolic events from baseline
• Change in Time in Therapeutic Range From Baseline [ Time Frame: 6, 12, and 24 months ]
  The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)
• Patient Satisfaction Through Total DASS Score [ Time Frame: baseline, 6 months, 12 months, 24 months ]
  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).

Original Secondary Outcome Measures (submitted: March 17, 2015)

• 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 monhts ]
• Time in therapeutic range from baseline [ Time Frame: 6, 12, and 24 months ]
• Patient satisfaction [ Time Frame: baseline, 6 months, 12 months, 24 months ]
• Provider Satisfaction [ Time Frame: baseline, 6 months, 12 monhts, 24 months ]

Current Other Pre-specified Outcome Measures (submitted: November 21, 2019)

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

Original Other Pre-specified Outcome Measures (submitted: March 17, 2015)

• Frequency and Type of Protocol Deviations From Both Participants and Study Staff [ Time Frame: Up to 2.25 years ]
• Provider knowledge [ Time Frame: Baseline ]
• Provider confidence [ Time Frame: Baseline, 2.25 years ]

Descriptive Information

• Brief Title: Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
• Official Title: 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Other Name: Coumadin

Study Arms

Experimental: Intervention Arm

All patients in the study will be in the intervention arm.

Intervention: Drug: Warfarin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2017): 51
• Original Estimated Enrollment (submitted: March 17, 2015): 75
• Actual Study Completion Date: June 25, 2017
• Actual Primary Completion Date: June 25, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02392104
• Other Study ID Numbers: 2014-1296
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Carla Staresinic, William S. Middleton Memorial Veterans Hospital
• Study Sponsor: William S. Middleton Memorial Veterans Hospital
• Collaborators: University of Wisconsin, Madison

Investigators

• Principal Investigator: Carla Staresinic, PharmD; William S. Middleton Memorial Veterans Hospital

• PRS Account: William S. Middleton Memorial Veterans Hospital
• Verification Date: November 2019