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Randomized Controlled Trial
. 2011 Jan 21;6(1):e14515.
doi: 10.1371/journal.pone.0014515.

A new multidisciplinary home care telemedicine system to monitor stable chronic human immunodeficiency virus-infected patients: a randomized study

Affiliations
Randomized Controlled Trial

A new multidisciplinary home care telemedicine system to monitor stable chronic human immunodeficiency virus-infected patients: a randomized study

Agathe León et al. PLoS One. .

Abstract

Background: Antiretroviral therapy has changed the natural history of human immunodeficiency virus (HIV) infection in developed countries, where it has become a chronic disease. This clinical scenario requires a new approach to simplify follow-up appointments and facilitate access to healthcare professionals.

Methodology: We developed a new internet-based home care model covering the entire management of chronic HIV-infected patients. This was called Virtual Hospital. We report the results of a prospective randomised study performed over two years, comparing standard care received by HIV-infected patients with Virtual Hospital care. HIV-infected patients with access to a computer and broadband were randomised to be monitored either through Virtual Hospital (Arm I) or through standard care at the day hospital (Arm II). After one year of follow up, patients switched their care to the other arm. Virtual Hospital offered four main services: Virtual Consultations, Telepharmacy, Virtual Library and Virtual Community. A technical and clinical evaluation of Virtual Hospital was carried out.

Findings: Of the 83 randomised patients, 42 were monitored during the first year through Virtual Hospital (Arm I) and 41 through standard care (Arm II). Baseline characteristics of patients were similar in the two arms. The level of technical satisfaction with the virtual system was high: 85% of patients considered that Virtual Hospital improved their access to clinical data and they felt comfortable with the videoconference system. Neither clinical parameters [level of CD4+ T lymphocytes, proportion of patients with an undetectable level of viral load (p = 0.21) and compliance levels >90% (p = 0.58)] nor the evaluation of quality of life or psychological questionnaires changed significantly between the two types of care.

Conclusions: Virtual Hospital is a feasible and safe tool for the multidisciplinary home care of chronic HIV patients. Telemedicine should be considered as an appropriate support service for the management of chronic HIV infection.

Trial registration: Clinical-Trials.gov: NCT01117675.

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Conflict of interest statement

Competing Interests: A León, C Cáceres, E Fernández, P Chausa, M Martin, C Codina, A Rousaud, A Milinkovic, M Laguno, M Larrousse, L Zamora, and EJ Gómez have no potential conflicts of interests. Neus Canal is employed by a commercial company, Health Economics and Outcomes Research IMS Health. E Martinez, F García, J Blanch and JL Blanco have received research grants from Abbott, Bristol-Myers Squibb, and Gilead Sciences. J Mallolas and JM Miro have received research grants from Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences and Roche. JM Gatell has received honoraria or research grants from Bristol-Myers Squibb, MSD, GlaxoSmithKline, Gilead Sciences, Tibotec, Roche, Boehringerngelheim, Abbott and Pfizer. This does not alter our adherence to all the PLoS ONE policies on sharing data and materials."

Figures

Figure 1
Figure 1. Architecture of the Virtual Hospital.
The architecture of this web-based system has two parts. The first was the hospital infrastructure, where we added our server to the existing demilitarised zone (DMZ) of the hospital, which was protected by a firewall and integrated into the hospital's information system network. Health professionals accessed this server via the hospital's intranet. The second part was the home infrastructure, where the patient accessed the server via a basic broadband connection and, for security reasons, through a virtual private network (VPN).
Figure 2
Figure 2. Electronic Health Record.
A. This figure shows the Virtual Consultation menu, where users select appointments conducted via standard care, videoconferencing, chat sessions or message exchanges. An electronic diary is also available so that at the end of the appointment, the patient and the professional could set a time for the next one. B. Here it shows an example of a teleconference appointment. Electronic Health Record contains demographic, epidemiological and clinical data (Hepatitis B or C coinfections; CD4 cell count and HIV-1 plasma viral load evolution; HAART-compliance and tolerance; comments of the infectious diseases physician) and is available to both professionals and patients during any of the sessions.
Figure 3
Figure 3. Telepharmacy.
A. Telepharmacy allows the pharmacist to receive electronic prescriptions, to perform virtual consultations about compliance, adverse events or interactions, and to send the antiretroviral medication to the patient's home by courier. B. This figure shows how professionals track patient's HAART-history. C. In this section, the patients can also visualise the evolution of their own treatments on charts and consult basic information on the antiretroviral drugs available.
Figure 4
Figure 4. Patient availability.
91 patients were assessed for eligibility, but four were excluded due to a lack of broadband, while a further four declined to participate. Of the remaining 83 randomised patients, 42 were monitored during the first year through Virtual Hospital (Arm I) and 41 through standard care (Arm II). Patients switched their care arm in year two of the study. Over the two years of follow-up, seven patients (8%) discontinued the study: two were lost to follow-up (one left the country and one was whereabouts unknown), two left the Virtual Hospital because they disapproved of the system, two developed tumours (one non-Hodgkin lymphoma and one hepatocellular carcinoma), and one patient was killed in a traffic accident. Overall, 76 patients (92%) completed the study.

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