What is the clinical evidence from this study?

Study design: RCT. Population: Oral anticoagulation therapy (n=140). Intervention: Home measurement of INR and online reporting vs. Conventional hospital-based treatment with INR measurement every 4 weeks. Primary outcome: Time in therapeutic range (TTR) (difference of 7% points, 95% CI 6.0-7.9, p=<2.2 x 10^-16).

January 23, 2011Open Access

Home Management of Oral Anticoagulation via Telemedicine Versus Conventional Hospital-Based Treatment

Q: What are the key findings of this study?

Home measurement of INR and online reporting once a week significantly increased time in therapeutic range by 7 percentage points (79.7% vs 72.7%) compared to conventional hospital-based monitoring.

HCHenry ChristensenHartford Hospital JLJens-Jacob LauterleinUniversity of Southern Denmark PSPatricia Diana SørensenUniversity of Southern Denmark

Key Result

Home measurement of INR and online reporting once a week significantly increased time in therapeutic range by 7 percentage points (79.7% vs 72.7%) compared to conventional hospital-based monitoring.

Study Design

Type

RCT (n=140)

Blinding

Open-label

Randomization

Randomized to three groups (1:1:1)

Multicenter

Structured PICO

Does home measurement of INR with online reporting and dosing improve time in therapeutic range in patients on oral anticoagulation compared to conventional hospital-based treatment?

Population

140 patients on lifelong oral anticoagulation therapy, capable of using the Internet and a point-of-care INR device, followed for approximately 1 year.

Intervention

Home measurement of INR using the CoaguChek XS system and online reporting/dosing via an expert computer system, performed either once weekly or twice weekly.

Comparator

Conventional treatment with INR measurement in the laboratory every 4 weeks and dose adjustment by letter.

Outcome

Time in therapeutic range (TTR)surrogate

Home-based INR monitoring with weekly online reporting and dosing significantly improves time in therapeutic range compared to conventional monthly laboratory testing.

Main Result

Mean Difference: 7 (95% CI 6–7.9)

Absolute Event Rate: 79.7% vs 72.7%

p-value: p=<2.2 x 10^-16

Limitations

Unblinded trial design
Participants were younger, more engaged, computer literate, and in better health than the general clinic population, potentially introducing selection bias
Relatively small sample size from a single center

Abstract

BACKGROUND AND OBJECTIVE: We have developed an expert computer system for the control of oral anticoagulation therapy, accessible by the patients via their own computer. To investigate if the weekly measurement and dosing of international normalized ratio (INR) at home using the online Internet-based system was superior to conventional treatment, we performed a randomized, controlled trial. PATIENTS AND METHODS: All 669 patients in our anticoagulation clinic were asked to participate in the trial, providing that they had Internet access and could use the CoaguChek XS system. A total of 140 patients were included and randomized to (A) once weekly measurement and report online, (B) twice weekly measurement and report online, and (C) continued conventional treatment with INR measurement in the lab every 4 weeks and dose adjustment by letter. RESULTS: Group A had 79.7% (95% CI 79.0-80.3) of time in therapeutic range (TTR), group B 80.2% (95% CI 79.4-80.9) of TTR, and group C 72.7% (95% CI 71.9-73.4) TTR. Groups A and B perform statistically significantly better than the conventional group C, with a difference of TTR of 7% points (p < 2.2 × 10(-16)), whereas no difference was seen between A and B. CONCLUSION: Home measurement of INR and the reporting and dosing of results online once a week increase TTR from 72% to 79% as compared to conventional computer-assisted monitoring in an anticoagulation clinic.

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