Effectiveness of Telemedicine in Reducing Hospitalizations in Patients Discharged from the Hospital Due to Heart Failure: A Randomized Clinical Trial Protocol
Edmar Geraldo Ribeiro, L. Brant, Lilian Cristina Rezende, R. Teixeira, Laura Carvalho Parreiras, T. Franco, A. Ribeiro, D. Malta
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Abstract
Fundament: Telemedicine for follow-up in heart failure (HF) patients is effective in reducing hospitalizations, total and cardiovascular mortality. However, few studies were conducted in low and middle income, where lower access to technology and illiteracy could impact the results. Objective: To assess the effectiveness of associating telemedicine strategies, when compared to usual care, in reducing hospitalizations related to HF in patients discharged from the hospital due to HF. Methods: Controlled, randomized, multicenter, parallel-arm clinical trial, with an allocation ratio of 1:1, blinded to outcome evaluation, in which 340 patients who were discharged from public hospitals in Belo Horizonte due to HF will be randomized. Patients will be followed for 6 months and the intervention group will receive, in addition to the usual care, Structured Telephone Support (STS) from a nurse, a doctor, and an educational program. Counseling will be according to a clinical decision tree. The level of significance in the statistical analysis will be 5%. Expected results: Reduction in the number of hospital readmissions and/or in hospitalization time, in addition to developing a software with a clinical decision tree for remote follow-up and patient education about HF adapted to local culture. Conclusions: The intention of this study is to develop a telemedicine strategy and assess whether or not, in addition to the usual care, it is effective in reducing hospitalizations and mortality from HF. If effective, the aforementioned strategy could reduce costs and hospital needs in the Unified Health System (SUS, in Portuguese) for patients with HF. These results will be even more relevant considering the pandemic of COVID-19. © 2022, Sociedade Brasileira de Cardiologia. All rights reserved.
远程医疗在减少因心力衰竭出院患者住院的有效性:一项随机临床试验方案
基础:远程医疗随访心力衰竭(HF)患者是有效的减少住院,总死亡率和心血管死亡率。然而,在低收入和中等收入人群中进行的研究很少,在这些人群中,较低的技术获取机会和文盲可能会影响结果。目的:与常规护理相比,评估联合远程医疗策略在减少因心衰出院的心衰患者因心衰住院的有效性。方法:采用对照、随机、多中心、平行组临床试验,分配比例为1:1,盲法结局评价,随机选取340例贝洛奥里藏特公立医院因HF出院的患者。患者将被随访6个月,干预组除了接受常规护理外,还将接受护士、医生的结构化电话支持(STS)和教育计划。咨询将根据临床决策树进行。统计分析的显著性水平为5%。预期结果:减少再入院次数和/或住院时间,此外还开发了一个具有临床决策树的软件,用于远程随访和适应当地文化的心衰患者教育。结论:本研究的目的是制定一种远程医疗策略,并评估在常规护理之外,远程医疗是否能有效降低心衰住院率和死亡率。如果有效,上述策略可以降低心力衰竭患者在统一卫生系统(SUS,葡萄牙语)中的成本和医院需求。考虑到COVID-19大流行,这些结果将更具相关性。©2022,巴西心脏病学会。版权所有。
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