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Trial record 44 of 229 for:    warfarin AND International

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
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Carla Staresinic, William S. Middleton Memorial Veterans Hospital

Tracking Information
First Submitted Date  ICMJE February 25, 2015
First Posted Date  ICMJE March 18, 2015
Last Update Posted Date November 8, 2017
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
 (submitted: March 19, 2015)
Rates of participant accrual [ Time Frame: up to 2.25 years ]
Number of participants who enroll vs. number of individuals invited
Original Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: March 19, 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 months ]
  • Time in therapeutic range from baseline [ Time Frame: 6, 12, and 24 months ]
  • Patient satisfaction [ Time Frame: baseline, 6 months, 12 months, 24 months ]
Original Secondary Outcome Measures  ICMJE
 (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: March 19, 2015)
Frequency and type of protocol deviations from both participants and study staff [ Time Frame: Up to 2.25 years ]
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  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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Arms  ICMJE Experimental: Intervention Arm
All patients in the study will be in the intervention arm.
Intervention: Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2017)
51
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2015)
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:

  • 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  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Carla Staresinic, PharmD, BCACP William S. Middleton Memorial Veterans Hospital
PRS Account William S. Middleton Memorial Veterans Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP