Telemedicine for Patients With Chronic Respiratory Insufficiency

Michele Vitacca

Status

Completed

Conditions

Chronic Respiratory Failure

Treatments

Device: telemedicine program

Study type

Interventional

Funder types

Other

Identifiers

NCT00563745

N°158

Details and patient eligibility

About

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.

Full description

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.

Enrollment

240 patients

Sex

All

Ages

12 to 85 years old

Volunteers

No Healthy Volunteers

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