Telemedicine for Patients With Chronic Respiratory Insufficiency

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.

Conditions
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Chronic Respiratory Failure

Intervention / Treatment
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* Device: telemedicine program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CRF patients discharged from Respiratory Unit with home MV Exclusion Criteria: Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness) Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home Being admitted to a nursing home Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family Refusal to give informed consent

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>Patients were submitted to a Telemedicine program for 1 year | Device: telemedicine program<br>* 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 will be provided.<br>* Other names: home care;|
| No Intervention: Control group<br>Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, ALS, Telemedicine, mechanical ventilation, Integrated care, strict follow up, impact and costs on health care resources, telemedicine programme, home mechanical ventilation (HMV), frail patients, chronic respiratory failure (CRF)