NCT00032591

The Home INR Study

CSP #481 - The Home INR Study (THINRS)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,922 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.

Detailed description

Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up. Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation. Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost. Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization. Study Abstract: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for PST is that it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events. Original plan was for a study at 32 sites with a total sample size of about 3,200 patients and a length of three years (one for recruitment and two years of follow-up). Final status was 28 sites that randomized 2922 patients in 2.75 years of recruitment with a minimum of two years of follow-up.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Weekly patient self-testing of prothrombin time
OTHER	High quality anticoagulation management (HQACM) with conventional monthly testing	HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.

Timeline

• Start date: 2003-08-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2002-03-28
• Last updated: 2014-04-15
• Results posted: 2014-02-06

Locations

29 sites across 2 countries: United States, Puerto Rico