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远程医疗支持对心力衰竭患者初级保健提供者与常规护理的影响:巴西心力衰竭与远程医疗(BRAHIT)研究中的一项实用集群随机试验方案。

Telemedicine Support for Primary Care Providers versus Usual Care in Patients with Heart Failure: Protocol of a Pragmatic Cluster Randomised Trial within the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) Study.

机构信息

Departamento de Clínica Médica, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro 21044-020, Brazil.

Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark.

出版信息

Int J Environ Res Public Health. 2023 May 24;20(11):5933. doi: 10.3390/ijerph20115933.


DOI:10.3390/ijerph20115933
PMID:37297537
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10253100/
Abstract

Heart failure is a prevalent condition and a frequent cause of hospital readmissions and poor quality of life. Teleconsultation support from cardiologists to primary care physicians managing patients with heart failure may improve care, but the effect on patient-relevant outcomes is unclear. We aim to evaluate whether collaboration through a novel teleconsultation platform in the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) project, tested on a previous feasibility study, can improve patient-relevant outcomes. We will conduct a parallel-group, two-arm, cluster-randomised superiority trial with a 1:1 allocation ratio, with primary care practices from Rio de Janeiro as clusters. Physicians from the intervention group practices will receive teleconsultation support from a cardiologist to assist patients discharged from hospitals after admission for heart failure. In contrast, physicians from the control group practices will perform usual care. We will include 10 patients per each of the 80 enrolled practices (n = 800). The primary outcome will be a composite of mortality and hospital admissions after six months. Secondary outcomes will be adverse events, symptoms frequency, quality of life, and primary care physicians' compliance with treatment guidelines. We hypothesise that teleconsulting support will improve patient outcomes.

摘要

心力衰竭是一种普遍存在的疾病,也是导致医院再次入院和生活质量下降的常见原因。心脏病专家为心力衰竭患者提供的远程咨询支持可以改善护理,但对患者相关结局的影响尚不清楚。我们旨在评估在巴西心力衰竭与远程医疗(BRAHIT)项目中通过一种新的远程咨询平台进行合作是否可以改善患者相关结局,该平台在前瞻性可行性研究中进行了测试。我们将开展一项平行组、两臂、集群随机优效性试验,采用 1:1 的分配比例,以里约热内卢的初级保健实践为集群。干预组实践的医生将获得心脏病专家的远程咨询支持,以协助因心力衰竭住院后出院的患者。相比之下,对照组实践的医生将进行常规护理。我们将纳入每个 80 个参与实践的患者(n = 800)。主要结局是 6 个月后死亡率和住院的复合结局。次要结局是不良事件、症状频率、生活质量以及初级保健医生对治疗指南的依从性。我们假设远程咨询支持将改善患者结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad23/10253100/fd6ab51e54e6/ijerph-20-05933-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad23/10253100/fd6ab51e54e6/ijerph-20-05933-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad23/10253100/fd6ab51e54e6/ijerph-20-05933-g001.jpg

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Telemedicine Support for Primary Care Providers versus Usual Care in Patients with Heart Failure: Protocol of a Pragmatic Cluster Randomised Trial within the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) Study.

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引用本文的文献

[1]
Telehealth Support From Cardiologists to Primary Care Physicians in Heart Failure Treatment: Mixed Methods Feasibility Study of the Brazilian Heart Insufficiency With Telemedicine Trial.

JMIR Cardio. 2025-4-17

本文引用的文献

[1]
Benefits of heart failure-specific pharmacotherapy in frail hospitalised patients: a cross-sectional study.

BMJ Open. 2022-9-19

[2]
Management of Medico-Legal Risks in Digital Health Era: A Scoping Review.

Front Med (Lausanne). 2022-1-11

[3]
A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance.

BMJ. 2021-9-30

[4]
Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction: The CONNECT-HF Randomized Clinical Trial.

JAMA. 2021-7-27

[5]
Rationale and design of the AMULET study: A new Model of telemedical care in patients with heart failure.

ESC Heart Fail. 2021-8

[6]
Symptom Status Questionnaire - Heart Failure - Brazilian Version: cross-cultural adaptation and content validation.

Heart Lung. 2021

[7]
Association between the nurse-led program with mental health status, quality of life, and heart failure rehospitalization in chronic heart failure patients.

Medicine (Baltimore). 2021-3-12

[8]
Cardiovascular Risk Factors and Social Development Index.

Front Cardiovasc Med. 2021-2-23

[9]
Psychometric properties of the EQ-5D-5L: a systematic review of the literature.

Qual Life Res. 2021-3

[10]
Social determinants of health and heart failure hospitalizations in Brazil.

Rev Esc Enferm USP. 2020

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