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

NCT02392104 | Completed Results DMC

• 1 other identifier: 2014-1296
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anticoagulation

Keywords

International Normalized Ratio; Warfarin

Outcome Measures

Primary Outcomes (3)

• Rates of Participant Accrual

  Number of participants who enroll vs. number of individuals invited

  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

  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

  24 months

Secondary Outcomes (4)

• Change in Frequency of Appointments From Baseline to End of Study

  12 and 24 months

• Bleeding and Thromboembolic Events From Baseline

  24 months

• Change in Time in Therapeutic Range From Baseline

  6, 12, and 24 months

• Patient Satisfaction Through Total DASS Score

  baseline, 6 months, 12 months, 24 months

Other Outcomes (1)

• Frequency and Type of Protocol Deviations From Both Participants and Study Staff

  Up to 2.25 years

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Drug: Warfarin

Interventions

Warfarin DRUG

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.

Also known as: Coumadin

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• William S. Middleton Memorial Veterans Hospital: lead
• University of Wisconsin, Madison: collaborator

Related Publications (1)

• 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.

  PMID: 31752504 DERIVED

MeSH Terms

Interventions

Warfarin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Andrea Porter, PharmD
• Organization: William S. Middleton Memorial Veterans Hospital

andrea.porter@wisc.edu

608-890-0742

Study Officials

• Carla Staresinic, PharmD

  William S. Middleton Memorial Veterans Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager, Anticoagulation Services

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 18, 2015
• Study Start: March 27, 2015
• Primary Completion: June 25, 2017
• Study Completion: June 25, 2017
• Last Updated: December 11, 2019
• Results First Posted: December 11, 2019

Record last verified: 2019-11