Trial Outcomes & Findings for Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care (NCT NCT00703963)

NCT ID: NCT00703963

Last Updated: 2014-08-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: baseline to 3 months
• Results posted on: 2014-08-28

Participant Flow

Subjects were recruited from the Mayo Clinic, Rochester, Minnesota from June 2007 to January 2009.

Participant milestones

Measure	Usual Care Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
Overall Study STARTED	100	100
Overall Study COMPLETED	93	86
Overall Study NOT COMPLETED	7	14

Reasons for withdrawal

Measure	Usual Care Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
Overall Study Withdrawal by Subject	7	13
Overall Study Physician Decision	0	1

Baseline Characteristics

Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care

Baseline characteristics by cohort

Measure	Usual Care n=100 Participants Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing n=100 Participants Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.	Total n=200 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	55 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	33 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	67 Participants n=7 Participants	127 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 3 months

Outcome measures

Measure	Usual Care n=93 Participants Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing n=86 Participants Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
Mean Percentage of Time in Therapeutic Range	48 percentage of time Standard Deviation 25	53 percentage of time Standard Deviation 27

SECONDARY outcome

Timeframe: baseline to 3 months

Outcome measures

Measure	Usual Care n=93 Participants Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing n=86 Participants Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
Mean Percentage of INR Tests Within the Therapeutic Range	45 percentage of tests Standard Deviation 22	52 percentage of tests Standard Deviation 22

SECONDARY outcome

Timeframe: baseline to 3 months

Outcome measures

Measure	Usual Care n=93 Participants Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing n=86 Participants Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
Mean Number of INR Tests Performed	10 INR tests Standard Deviation 6	14 INR tests Standard Deviation 9

Adverse Events

Usual Care

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Patient Self Testing

Serious events: 8 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=93 participants at risk Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing n=86 participants at risk Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
Vascular disorders Transient ischemic attack	1.1% 1/93 • Subjects were followed up for 90 days after hospital dismissal.	2.3% 2/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Possible transient ischemic attack	1.1% 1/93 • Subjects were followed up for 90 days after hospital dismissal.	0.00% 0/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Hemothorax	0.00% 0/93 • Subjects were followed up for 90 days after hospital dismissal.	2.3% 2/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Evacuation of subdural hematoma	0.00% 0/93 • Subjects were followed up for 90 days after hospital dismissal.	1.2% 1/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Bloody pericardial effusion	1.1% 1/93 • Subjects were followed up for 90 days after hospital dismissal.	2.3% 2/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Pulmonary embolism	0.00% 0/93 • Subjects were followed up for 90 days after hospital dismissal.	1.2% 1/86 • Subjects were followed up for 90 days after hospital dismissal.

Other adverse events

Measure	Usual Care n=93 participants at risk Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Patient Self Testing n=86 participants at risk Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
Eye disorders Temporary visual change	2.2% 2/93 • Subjects were followed up for 90 days after hospital dismissal.	0.00% 0/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Bleeding after shaving	1.1% 1/93 • Subjects were followed up for 90 days after hospital dismissal.	0.00% 0/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Epistaxis	1.1% 1/93 • Subjects were followed up for 90 days after hospital dismissal.	0.00% 0/86 • Subjects were followed up for 90 days after hospital dismissal.
Vascular disorders Bleeding scalp	0.00% 0/93 • Subjects were followed up for 90 days after hospital dismissal.	1.2% 1/86 • Subjects were followed up for 90 days after hospital dismissal.

Additional Information

Dr. Hartzell V. Schaff

Mayo Clinic

Phone: 507-255-7068

Email: schaff@mayo.edu

Results disclosure agreements

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