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Efficacy and Costs of Telehealth for the Management of COPD: A Multicenter, Randomized Controlled Trial
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A4546 - Efficacy and Costs of Telehealth for the Management of COPD: A Multicenter, Randomized Controlled Trial
Author Block: J. B. Soriano1, F. García-Río2, E. Vázquez Espinosa1, J. Díaz de Atauri3, L. López Yepes3, R. Galera Martínez4, G. Peces Barba5, M. Pérez Warnisher5, M. García Salmones6, G. Segrelles6, I. Ramos7, J. Conforto7, P. Gonzalez7, S. Jafri8, J. Ancochea1; 1Hospital Universitario de la Princesa, Madrid, Spain, 2Servicio de Neumología, Hospital Universitario La Paz, Madrid, Spain, 3Hospital 12 de Octubre, Madrid, Spain, 4Hospital Universitario La Paz, Madrid, Spain, 5Fundación Jiménez Díaz, Madrid, Spain, 6Hospital Rey Juan Carlos, Madrid, Spain, 7Linde Healthcare España, Madrid, Spain, 8The Linde Group, Munich, Germany.
RATIONALE: Increasing attention has been placed on identifying and validating innovative COPD care models such as Telehealth (TH), particularly for high cost patients with severe COPD and/or frequent acute exacerbations. METHODS: PROMETE II is a multicenter, randomized controlled trial lasting 12-months conducted in five hospitals in Madrid, Spain. Severe stable COPD patients (FEV1 below 50% predicted and 6 weeks without a COPD exacerbation) were randomized to either a specific monitoring protocol with TH or routine clinical practice (RCP). The main objective was to reduce the number of COPD exacerbations leading to ER visits/hospital admissions. RESULTS: 237 COPD patients were recruited, and 229 (96.6%) were randomized to TH (n=115) or RCP (n=114). Participants had a mean±SD age of 71±8 years and 80% were men. There were no statistical differences in the baseline parameters of both groups. There were no statistically significant differences in the primary efficacy analysis of the proportion of participants who had a severe COPD exacerbation leading to ER visits or a hospital admission (59.5% in TH vs. 55.7% in RCP; p=0.556). Similarly, the mean number of exacerbations over the 12-month period was comparable between groups, 1.0 in TH vs. 0.9 in RCP (p=0.286). However, there was a non-significant trend towards a shorter mean total duration of hospitalization in the TH group (18.9±16.4 days) compared to the RCP group (22.3±19.7 days), p=0.353, and of fewer days in the ICU, 6.0±4.6 vs.13.3±11.1 days, p=0.349. At month 12, the number of all-cause deaths was comparable between groups (11 in TH vs. 13 in RCP). Lastly, telehealth was evaluated highly positively by both participating physicians and patients. CONCLUSION: We conclude that remote patient management using this monitoring protocol did not reduce the COPD-related ER visits or hospital admissions compared to routine clinical care within 12 months.
Author Block: J. B. Soriano1, F. García-Río2, E. Vázquez Espinosa1, J. Díaz de Atauri3, L. López Yepes3, R. Galera Martínez4, G. Peces Barba5, M. Pérez Warnisher5, M. García Salmones6, G. Segrelles6, I. Ramos7, J. Conforto7, P. Gonzalez7, S. Jafri8, J. Ancochea1; 1Hospital Universitario de la Princesa, Madrid, Spain, 2Servicio de Neumología, Hospital Universitario La Paz, Madrid, Spain, 3Hospital 12 de Octubre, Madrid, Spain, 4Hospital Universitario La Paz, Madrid, Spain, 5Fundación Jiménez Díaz, Madrid, Spain, 6Hospital Rey Juan Carlos, Madrid, Spain, 7Linde Healthcare España, Madrid, Spain, 8The Linde Group, Munich, Germany.
RATIONALE: Increasing attention has been placed on identifying and validating innovative COPD care models such as Telehealth (TH), particularly for high cost patients with severe COPD and/or frequent acute exacerbations. METHODS: PROMETE II is a multicenter, randomized controlled trial lasting 12-months conducted in five hospitals in Madrid, Spain. Severe stable COPD patients (FEV1 below 50% predicted and 6 weeks without a COPD exacerbation) were randomized to either a specific monitoring protocol with TH or routine clinical practice (RCP). The main objective was to reduce the number of COPD exacerbations leading to ER visits/hospital admissions. RESULTS: 237 COPD patients were recruited, and 229 (96.6%) were randomized to TH (n=115) or RCP (n=114). Participants had a mean±SD age of 71±8 years and 80% were men. There were no statistical differences in the baseline parameters of both groups. There were no statistically significant differences in the primary efficacy analysis of the proportion of participants who had a severe COPD exacerbation leading to ER visits or a hospital admission (59.5% in TH vs. 55.7% in RCP; p=0.556). Similarly, the mean number of exacerbations over the 12-month period was comparable between groups, 1.0 in TH vs. 0.9 in RCP (p=0.286). However, there was a non-significant trend towards a shorter mean total duration of hospitalization in the TH group (18.9±16.4 days) compared to the RCP group (22.3±19.7 days), p=0.353, and of fewer days in the ICU, 6.0±4.6 vs.13.3±11.1 days, p=0.349. At month 12, the number of all-cause deaths was comparable between groups (11 in TH vs. 13 in RCP). Lastly, telehealth was evaluated highly positively by both participating physicians and patients. CONCLUSION: We conclude that remote patient management using this monitoring protocol did not reduce the COPD-related ER visits or hospital admissions compared to routine clinical care within 12 months.
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