Chronic Respiratory Failure Clinical Trial
Official title:
Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.
In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM programme (supported by continuous availability of a call centre and a pulsed oxygen system) is cost/effective saving health care resources.
Background: Integrated care and strict follow up have been recommended for frail patients
with chronic respiratory failure (CRF) discharged at home.
Objectives: To evaluate impact and costs on health care resources of a telemedicine
programme (TM) for severe patients discharged at home with oxygen and/or home mechanical
ventilation (HMV) with a high risk of hospital readmission.
Design: Prospective randomised controlled trial. Setting: Respiratory Rehabilitation Unit S.
Maugeri Foundation between May 2004 and March 2007.
Participants: 240 CRF patients will be randomised into an intervention group (TM) and a
control Group, which received current usual care (educational plan, 3 months outpatient
visits).
Interventions: one year TM with continuous (h 24) on call accessibility to a nurse and/or a
pulmonologist, a web-based call centre and a pulse oxymetry tracing.
Main outcome measures: survival, admissions to emergency room (ER), hospitalisations, urgent
general practitioner (GP) calls, home relapses; probability to remain free from the above
events will be also compared among groups. TM and health Care System costs as customer
satisfaction will be also collected.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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