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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Carla Staresinic, William S. Middleton Memorial Veterans Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anticoagulation
Intervention Drug: Warfarin
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Extended INR Follow-up Interval Group
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 50 [1]
Completed 39
Not Completed 11
Reason Not Completed
discontinuation of warfarin             3
bleeding event             1
transferred care to another doctor             2
INR goal range changed             1
admitted to skilled nursing facility             3
INRs drawn by visiting nurse services             1
[1]
one participant enrolled but was removed prior to starting study protocol
Arm/Group Title Intervention Arm
Hide Arm/Group Description

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

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.

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
71.4  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
1
   2.0%
Male
49
  98.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
49
  98.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
HAS-BLED score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants
1.8  (0.9)
[1]
Measure Description: The HAS-BLED score evaluates a patient's bleeding risk. HAS-BLED is the official name of the tool to assess risk. Scores range from 0-9. Scores of 3 or higher indicate a high bleeding risk.
1.Primary Outcome
Title Rates of Participant Accrual
Hide Description Number of participants who enroll vs. number of individuals invited
Time Frame up to 2.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
107 invited to participate in the study, not all enrolled or started the study
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients invted
107
 100.0%
Patient enrolled in study
51
  47.7%
Patients analyzed for study
50
  46.7%
2.Primary Outcome
Title Number of Participants Able to be Scheduled for at Least One 12-week Interval
Hide Description This outcome will determine the number of participants able to be scheduled for at least one 12-week interval
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
36
  72.0%
3.Primary Outcome
Title Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals
Hide Description The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
15
  30.0%
4.Secondary Outcome
Title Change in Frequency of Appointments From Baseline to End of Study
Hide Description This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
44 participants remained in the study at 12 months
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: visits per 12 months
Planned anticoagulation visits (baseline) 12.67  (2.56)
Planned anticoagulation visits (0-12 months) 10.43  (3.58)
5.Secondary Outcome
Title Bleeding and Thromboembolic Events From Baseline
Hide Description This outcome will determine the number of bleeding and thromboembolic events from baseline
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: events
Number of thromboembolic events 2
Number of major bleeding events 6
Number of serious bleeding events 16
6.Secondary Outcome
Title Change in Time in Therapeutic Range From Baseline
Hide Description The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)
Time Frame 6, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
49 participants at 12 months, 44 participants at 24 months
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: change in percentage of TTR
6 months Number Analyzed 50 participants
-12.2  (26.4)
12 months Number Analyzed 49 participants
-7.3  (18.3)
24 months Number Analyzed 44 participants
-4.4  (13.2)
7.Secondary Outcome
Title Patient Satisfaction Through Total DASS Score
Hide Description 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).
Time Frame baseline, 6 months, 12 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 42.89  (12.08)
6 months 43.99  (11.75)
12 months 38.83  (11.53)
24 months 46.82  (15.16)
8.Other Pre-specified Outcome
Title Frequency and Type of Protocol Deviations From Both Participants and Study Staff
Hide Description This outcome determines the frequency and type of protocol deviations from both participants and study staff
Time Frame Up to 2.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
634 eligible participant visits
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 50
Overall Number of Units Analyzed
Type of Units Analyzed: Participant visits
634
Measure Type: Number
Unit of Measure: percentage of visits
extended interval visits scheduled correctly 94.3
Deviations too short 3.0
Deviations too long 2.7
Time Frame 24 months
Adverse Event Reporting Description

Major bleeding was defined as a fatal or symptomatic bleed into a critical area or organ, bleeding leading to hospitalization, or transfusion of two units or more of packed red blood cells. This definition is the standard definition used by the Anticoagulation Clinic to report events.

Serious bleeding was defined as bleeding leading to emergency or urgent care visit or additional testing required.

 
Arm/Group Title Intervention Arm
Hide Arm/Group Description

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

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.

All-Cause Mortality
Intervention Arm
Affected / at Risk (%)
Total   0/50 (0.00%)    
Hide Serious Adverse Events
Intervention Arm
Affected / at Risk (%) # Events
Total   15/50 (30.00%)    
Blood and lymphatic system disorders   
Multiple myeloma   1/50 (2.00%)  1
Cardiac disorders   
Aortic valve disease   2/50 (4.00%)  2
Chest pain - cardiac   1/50 (2.00%)  2
Heart failure   3/50 (6.00%)  5
Gastrointestinal disorders   
Colitis   1/50 (2.00%)  1
Colonic hemorrhage   1/50 (2.00%)  1
Hemorrhoidal hemorrhage   1/50 (2.00%)  1
Hemorrhoids   2/50 (4.00%)  2
Small intestinal obstruction   1/50 (2.00%)  1
Upper gastrointestinal hemorrhage   1/50 (2.00%)  1
Infections and infestations   
Bronchial infection   1/50 (2.00%)  1
Lung infection   1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders   
Arthritis   1/50 (2.00%)  1
Back pain   1/50 (2.00%)  1
Renal and urinary disorders   
Severe AKI   1/50 (2.00%)  1
Urinary retention   1/50 (2.00%)  1
Urinary tract pain   1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary hypertension   1/50 (2.00%)  1
Skin and subcutaneous tissue disorders   
RLE cellulitis   1/50 (2.00%)  1
Vascular disorders   
Thromboembolic event   1/50 (2.00%)  2
Post-op monitoring for vascular procedure   1/50 (2.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Arm
Affected / at Risk (%) # Events
Total   19/50 (38.00%)    
Blood and lymphatic system disorders   
Major bleeding   6/50 (12.00%)  6
Serious bleeding   16/50 (32.00%)  22
Vascular disorders   
Thromboembolism   1/50 (2.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrea Porter, PharmD
Organization: William S. Middleton Memorial Veterans Hospital
Phone: 608-890-0742
EMail: andrea.porter@wisc.edu
Layout table for additonal information
Responsible Party: Carla Staresinic, William S. Middleton Memorial Veterans Hospital
ClinicalTrials.gov Identifier: NCT02392104    
Other Study ID Numbers: 2014-1296
First Submitted: February 25, 2015
First Posted: March 18, 2015
Results First Submitted: October 16, 2019
Results First Posted: December 11, 2019
Last Update Posted: December 11, 2019