Simon Stewart1, Yih-Kai Chan1, Chiew Wong2, Garry Jennings3, Paul Scuffham4, Adrian Esterman5, Melinda Carrington1. 1. Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia. 2. Non-intervention Cardiology, Western Health, Melbourne, Australia. 3. Baker IDI Heart and Diabetes Institute, Melbourne, Australia. 4. Centre for Applied Health Economics & Menzies Health Institute Queensland, Griffith University, Brisbane, Australia. 5. University of South Australia, Adelaide, Australia and Centre for Research Excellence in Chronic Disease Prevention, James Cook University, Cairns, Australia.
Abstract
AIMS: The aim of this study was to determine the effectiveness of a long-term, nurse-led, multidisciplinary programme of home/clinic visits in preventing progressive cardiac dysfunction in individuals at risk of developing de novo chronic heart failure (CHF). METHODS AND RESULTS: A pragmatic, single-centre (tertiary-referral hospital with specialist cardiological services), open-label, randomized controlled trial with blinded endpoint adjudication was carried out. In total, 624 cardiac inpatients (66 ± 11 years, 71% male, and 70% with CAD) were randomly allocated (1:1) to standard care or the study intervention. The intention-to-treat cohort comprised 310 standard care and 301 intervention participants. During 51.0 ± 8.2 months follow-up, 38/310 (12%) standard care [mean event-free survival 1865 days, 95% confidence interval (CI) 1817-1913 days] vs. 41/301 (14%) intervention participants (1855 days, 95% CI 1804-1906 days) experienced the primary composite endpoint of de novo CHF hospitalization or all-cause mortality (P = 0.574). Although there were no statistically significant differences in the rate of cardiovascular-related and emergency hospitalizations, the NIL-CHF (Nurse-led Intervention for Less Chronic Heart Failure) group accumulated 478 (0.214 ± 0.70 vs. 0.095 ± 0.284 days/participant/month; P = 0.052) and 1097 fewer days of hospital stay (0.391 ± 1.80 vs. 0.199 ± 0.47 days/participant/month; P = 0.023), respectively, compared with standard care. The intervention group also showed better cardiac recovery on echocardiography at 3 years [81/226 (35.8%) vs. 56/225 (24.9%), odds ratio 1.44, 95% CI 1.08-1.92, P = 0.011]. CONCLUSIONS: Relative to a high level of standard care, the NIL-CHF intervention was ineffective in preventing CHF and rehospitalization. On the other hand, it was associated with reduced hospital stay and improved cardiac function over the long term. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (No. 12608000022369).
RCT Entities:
AIMS: The aim of this study was to determine the effectiveness of a long-term, nurse-led, multidisciplinary programme of home/clinic visits in preventing progressive cardiac dysfunction in individuals at risk of developing de novo chronic heart failure (CHF). METHODS AND RESULTS: A pragmatic, single-centre (tertiary-referral hospital with specialist cardiological services), open-label, randomized controlled trial with blinded endpoint adjudication was carried out. In total, 624 cardiac inpatients (66 ± 11 years, 71% male, and 70% with CAD) were randomly allocated (1:1) to standard care or the study intervention. The intention-to-treat cohort comprised 310 standard care and 301 intervention participants. During 51.0 ± 8.2 months follow-up, 38/310 (12%) standard care [mean event-free survival 1865 days, 95% confidence interval (CI) 1817-1913 days] vs. 41/301 (14%) intervention participants (1855 days, 95% CI 1804-1906 days) experienced the primary composite endpoint of de novo CHF hospitalization or all-cause mortality (P = 0.574). Although there were no statistically significant differences in the rate of cardiovascular-related and emergency hospitalizations, the NIL-CHF (Nurse-led Intervention for Less Chronic Heart Failure) group accumulated 478 (0.214 ± 0.70 vs. 0.095 ± 0.284 days/participant/month; P = 0.052) and 1097 fewer days of hospital stay (0.391 ± 1.80 vs. 0.199 ± 0.47 days/participant/month; P = 0.023), respectively, compared with standard care. The intervention group also showed better cardiac recovery on echocardiography at 3 years [81/226 (35.8%) vs. 56/225 (24.9%), odds ratio 1.44, 95% CI 1.08-1.92, P = 0.011]. CONCLUSIONS: Relative to a high level of standard care, the NIL-CHF intervention was ineffective in preventing CHF and rehospitalization. On the other hand, it was associated with reduced hospital stay and improved cardiac function over the long term. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (No. 12608000022369).
Authors: Naomi Aerts; Sibyl Anthierens; Peter Van Bogaert; Lieve Peremans; Hilde Bastiaens Journal: Int J Environ Res Public Health Date: 2022-07-11 Impact factor: 4.614
Authors: Mercedes Gomez Del Pulgar; Miguel Angel Cuevas-Budhart; Sonsoles Hernández-Iglesias; Maria Kappes; Veronica Andrea Riquelme Contreras; Esther Rodriguez-Lopez; Alina Maria De Almeida Souza; Maximo A Gonzalez Jurado; Almudena Crespo Cañizares Journal: Public Health Rev Date: 2022-09-14