Trial Outcomes & Findings for Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service (NCT NCT02392104)

NCT ID: NCT02392104

Last Updated: 2019-12-11

Results Overview

Number of participants who enroll vs. number of individuals invited

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: up to 2.25 years
• Results posted on: 2019-12-11

Participant Flow

Participant milestones

Measure	Extended INR Follow-up Interval Group 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 Study STARTED	50
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Extended INR Follow-up Interval Group 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 Study discontinuation of warfarin	3
Overall Study bleeding event	1
Overall Study transferred care to another doctor	2
Overall Study INR goal range changed	1
Overall Study admitted to skilled nursing facility	3
Overall Study INRs drawn by visiting nurse services	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention Arm n=50 Participants 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.
Age, Continuous	71.4 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
HAS-BLED score	1.8 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants

PRIMARY outcome

Timeframe: up to 2.25 years

Population: 107 invited to participate in the study, not all enrolled or started the study

Number of participants who enroll vs. number of individuals invited

Outcome measures

Measure	Intervention Arm n=107 Participants 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.
Rates of Participant Accrual Number of patients invted	107 Participants
Rates of Participant Accrual Patient enrolled in study	51 Participants
Rates of Participant Accrual Patients analyzed for study	50 Participants

PRIMARY outcome

Timeframe: 24 months

This outcome will determine the number of participants able to be scheduled for at least one 12-week interval

Outcome measures

Measure	Intervention Arm n=50 Participants 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.
Number of Participants Able to be Scheduled for at Least One 12-week Interval	36 Participants

PRIMARY outcome

Timeframe: 24 months

The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals

Outcome measures

Measure	Intervention Arm n=50 Participants 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.
Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals	15 Participants

SECONDARY outcome

Timeframe: 12 and 24 months

Population: 44 participants remained in the study at 12 months

This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)

Outcome measures

Measure	Intervention Arm n=44 Participants 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.
Change in Frequency of Appointments From Baseline to End of Study Planned anticoagulation visits (baseline)	12.67 visits per 12 months Standard Deviation 2.56
Change in Frequency of Appointments From Baseline to End of Study Planned anticoagulation visits (0-12 months)	10.43 visits per 12 months Standard Deviation 3.58

SECONDARY outcome

Timeframe: 24 months

This outcome will determine the number of bleeding and thromboembolic events from baseline

Outcome measures

Measure	Intervention Arm n=50 Participants 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.
Bleeding and Thromboembolic Events From Baseline Number of serious bleeding events	16 events
Bleeding and Thromboembolic Events From Baseline Number of thromboembolic events	2 events
Bleeding and Thromboembolic Events From Baseline Number of major bleeding events	6 events

SECONDARY outcome

Timeframe: 6, 12, and 24 months

Population: 49 participants at 12 months, 44 participants at 24 months

The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)

Outcome measures

Measure	Intervention Arm n=50 Participants 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.
Change in Time in Therapeutic Range From Baseline 6 months	-12.2 change in percentage of TTR Standard Deviation 26.4
Change in Time in Therapeutic Range From Baseline 12 months	-7.3 change in percentage of TTR Standard Deviation 18.3
Change in Time in Therapeutic Range From Baseline 24 months	-4.4 change in percentage of TTR Standard Deviation 13.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Intervention Arm n=48 Participants 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.
Patient Satisfaction Through Total DASS Score baseline	42.89 score on a scale Standard Deviation 12.08
Patient Satisfaction Through Total DASS Score 6 months	43.99 score on a scale Standard Deviation 11.75
Patient Satisfaction Through Total DASS Score 12 months	38.83 score on a scale Standard Deviation 11.53
Patient Satisfaction Through Total DASS Score 24 months	46.82 score on a scale Standard Deviation 15.16

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2.25 years

Population: 634 eligible participant visits

This outcome determines the frequency and type of protocol deviations from both participants and study staff

Outcome measures

Measure	Intervention Arm n=634 participant visits 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.
Frequency and Type of Protocol Deviations From Both Participants and Study Staff extended interval visits scheduled correctly	94.3 percentage of visits
Frequency and Type of Protocol Deviations From Both Participants and Study Staff Deviations too short	3.0 percentage of visits
Frequency and Type of Protocol Deviations From Both Participants and Study Staff Deviations too long	2.7 percentage of visits

Adverse Events

Intervention Arm

Serious events: 15 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention Arm n=50 participants at risk 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.
Blood and lymphatic system disorders Multiple myeloma	2.0% 1/50 • Number of events 1 • 24 months 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.
Cardiac disorders Aortic valve disease	4.0% 2/50 • Number of events 2 • 24 months 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.
Cardiac disorders Chest pain - cardiac	2.0% 1/50 • Number of events 2 • 24 months 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.
Cardiac disorders Heart failure	6.0% 3/50 • Number of events 5 • 24 months 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.
Gastrointestinal disorders Colitis	2.0% 1/50 • Number of events 1 • 24 months 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.
Gastrointestinal disorders Colonic hemorrhage	2.0% 1/50 • Number of events 1 • 24 months 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.
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.0% 1/50 • Number of events 1 • 24 months 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.
Gastrointestinal disorders Hemorrhoids	4.0% 2/50 • Number of events 2 • 24 months 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.
Gastrointestinal disorders Small intestinal obstruction	2.0% 1/50 • Number of events 1 • 24 months 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.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.0% 1/50 • Number of events 1 • 24 months 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.
Infections and infestations Bronchial infection	2.0% 1/50 • Number of events 1 • 24 months 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.
Infections and infestations Lung infection	2.0% 1/50 • Number of events 1 • 24 months 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.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 1/50 • Number of events 1 • 24 months 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.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/50 • Number of events 1 • 24 months 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.
Renal and urinary disorders Severe AKI	2.0% 1/50 • Number of events 1 • 24 months 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.
Renal and urinary disorders Urinary retention	2.0% 1/50 • Number of events 1 • 24 months 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.
Renal and urinary disorders Urinary tract pain	2.0% 1/50 • Number of events 1 • 24 months 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.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	2.0% 1/50 • Number of events 1 • 24 months 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.
Skin and subcutaneous tissue disorders RLE cellulitis	2.0% 1/50 • Number of events 1 • 24 months 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.
Vascular disorders Thromboembolic event	2.0% 1/50 • Number of events 2 • 24 months 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.
Vascular disorders Post-op monitoring for vascular procedure	2.0% 1/50 • Number of events 1 • 24 months 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.

Other adverse events

Measure	Intervention Arm n=50 participants at risk 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.
Vascular disorders Thromboembolism	2.0% 1/50 • Number of events 2 • 24 months 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.
Blood and lymphatic system disorders Major bleeding	12.0% 6/50 • Number of events 6 • 24 months 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.
Blood and lymphatic system disorders Serious bleeding	32.0% 16/50 • Number of events 22 • 24 months 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.

Additional Information

Andrea Porter, PharmD

William S. Middleton Memorial Veterans Hospital

Phone: 608-890-0742

Email: andrea.porter@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place