1 ICEHTM st International Conference on E-HEALTH and TELEMEDICINE October 2011 Nicosia - North Cyprus A Telehomecare monitoring project in Cystic Fibrosis Murgia F, Alghisi F, Majo F, Montemitro E, Lucidi V and Bella S
2 CF and telemedicine 2 In CF follow-up it s known that continuous monitoring of lung function is able to prevent bronchopulmonary exacerbations reducing progressive lung damage responsible of the patient s exitus for lung insufficiency (Rajan S, Saiman L. Pulmonary infections in patients with cystic fibrosis. Semin Respir Infect 2002;17:47-56)
3 Our Experience 3 Since 2001 distance monitoring of lung parameters is used in the follow-up of patients with CF in the Cystic Fibrosis Centre of the Bambino Gesù Children s Hospital - IRCCS - in Rome
4 4 Oxitel: the previous device
5 Bella S, Murgia F and coll: Five years of Telemedicine in Cystic Fibrosis Disease. Clin Ter Nov-Dec;160(6): open label trial in CF patients followed from 2001 to 2005 Intervention: administration of THC in addition to standard therapy Instruments: Vivisol OXITEL M32 and cableconnected One Flow spirometer Outcome measure: FEV1 values over time and data from Hospital admission in same period
6 Bella S, Murgia F and coll: Five years of Telemedicine in Cystic Fibrosis Disease. Clin Ter Nov-Dec;160(6): Results: in CF patients who used Telehomecare toward CF controls: statistically significant reduction of admissions in Day Hospital increase in the use of antibiotic e.v. tendency toward better stability of lung function
7 Our Activity To date 30 patients are included in THC program Instruction of patients and parents by staff on the use of the device and on data transmission Vivitel instrumentation: small (70x80x30 mm), light (100 g), battery alimented (lithium 3 V), projected to be used by patients. spirometry (FVC, FEV1, FEV1%, PEF, FEF 25-75, FET, flow-volume and volume-time curves) pulse oximetry with registration of SaO2, heart rate and enhancement of desaturation events 7
8 the current device 8
9 9 At Home Patient: registration of oxygen saturation and heart rate by night spirometry in the morning, after chest FKT and answering a simple questionnaire regarding some pulmonary symptoms data transmission by home telephone
10 Data Flow Data recording in a dedicated web server 10 Data download by dedicated healthcare professionals in hospital in a protected way Data interpretation by WinspiroPRO Software (also in graphs)
11 In Hospital Healthcare professionals : Download data on a PC connected to the Net. Store data from each patient in a local database. Establishes the timing of transmissions according to the clinical situation, on average 2 times a week. Patients may decide to transmit, even without calling the doctors. THC patients are treated by the same guidelines compared to patients who do not. 11
12 Winspiro Pro 12 Spirometric curves and main parameters (FEV1, FVC, PEF, FEF25-75). Trend of FEV1 in time and comparation of previous parameters with the new ones. Variations are expressed as percentage difference. Pulse oxymetry curves graph of the SaO2 and hearth rate trend (usually all night). Data include mean, minimum and maximum SaO2, T90 and T89
13 Spyrometry 13
14 Pulse Oximetry 14
15 Intervention Parameters 15 we considered significant : Acute reduction of FEV1 (>10% compared to previous value recorded in stable clinical conditions Reductions below 80% of the maximum value of oxygen hemoglobin saturation, reduction of mean SaO2 and increase over 5% of T90.
16 Work Flow 16 Every transmission for each patient is printed and stored in a paper archive. Each patient is called on the phone to gather medical records and to share the results Anamnestic data and graphs obtained are daily discussed in a briefing between CF Centre healthcare professionals for an overall evaluation and to decide on any therapeutic action
17 Decisional Flow 17 Patients with significant decrease of SaO2 and/or FEV1 are invited to transmit soon further test. In some cases antibiotic home therapy is prescribed on the basis of the last sputum culture collected in hospital. In other cases patients are invited in the CF Centre for a clinical evaluation, to perform further testing, or to be admitted. In any case the next data transmission is scheduled
18 Log of transmissions 18 For each transmission are collected by dedicated professionals : Date, time, patient s name, number and type of tests sent, results, brief evaluation, telephone number used to call back the patient, person who answered the operator s call, clinical information reported, any therapeutic measure decided by physicians, name of the doctor who prescribed, eventual need for hospital admission. Every calibration procedure performed or technical assistance needed.
19 Other procedures 19 Monthly summary of the transmitted test and patient s compliance to telemonitoring system are calculated. Data is made available securely on the intranet to the entire staff dedicated to assisting. Data is made available at the request of each patient with a secure system, in accordance with current laws.
20 Device maintenance 20 On every scheduled hospital admission, patients use to bring the device for a check-up and calibration. In case of problem, when it is not possible to fix the instrument in hospital, Vivisol Assistance Service is activated. In some cases is possible to repair the device at patient s home. Any critical arisen during the procedure and their solutions are noted
21 Contacts with Patient and Families Continous training program on the correct use of the device is performed. To facilitate contacts an account was activated. Questionnaires about any issue on the device and on the psychological impact of the procedure are administered. Continuous contacts with Vivisol Assistance are maintained to report any noticed issue with the aim of improve service quality. Healthcare professional dedicated to telehomecare periodically revise data collected for writing report and scientific works. 21
23 Discussion : Compliance 23 During the follow-up, we recorded an average compliance (transmissions/patient days) of about 10%. Considering our recommendation to transmit about twice a week, optimal expected compliance should be 40% (on 5 working days per week). We should consider that chronic patients are overwhelmed by many additional interventions. Certainly compliance must be considered when planning such an intervention and possible related clinical trials.
24 Discussion: contacts and calls 24 After receiving transmission in most cases a contact was soon established, direct or by phone (761contacts/1008 transmissions = 75,5%). On 835 calls usually carried out on cell phone only 588 (70,1%) had a good outcome in the first try. This figure, although slightly increased in our experience, are critical in the procedure and should be improved by acting on organizational aspects of the project.
25 Discussion: lung exacerbations 25 US CF Consensus Conference (1994): presence of clinical symptoms such as cough, dyspnea, increase or change in sputum quality, asthenia with or without decrease of FEV1. Isolated FEV1 decrease should not be considered as a symptom of relapse (Sarfaraz, 2010)
26 Discussion: lung exacerbations 26 It is necessary that each transmission should be integrated with direct contact with patient or parents to recall anamnesis. This data is essential for a correct interpretation of obtained data (even if they are into the normal range). The effectiveness of the questionnaire of symptoms of the device and its practical value is yet to be verified
27 Conclusions 27 Telemedicine represents at today a promising new tool for patients and healthcare professionals, that under certain conditions can improve the quality of assistance and possibly also to reduce costs. It is necessary, however, that its adoption is supported by careful study of validation and a general focus on some new issues arising from them.
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