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

Leonardo Graever (), Aurora Felice Castro Issa, Viviane Belidio Pinheiro da Fonseca, Marcelo Machado Melo, Gabriel Pesce de Castro da Silva, Isabel Cristina Pacheco da Nóbrega, Leonardo Cançado Monteiro Savassi, Mariana Borges Dias, Maria Kátia Gomes, Jose Roberto Lapa e Silva, Raphael Mendonça Guimarães, Renato Cony Seródio, Anne Frølich, Henrik Gudbergsen, Janus Christian Jakobsen and Helena Dominguez
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Leonardo Graever: Departamento de Clínica Médica, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro 21044-020, Brazil
Aurora Felice Castro Issa: Instituto Nacional de Cardiologia, Rio de Janeiro 22240-006, Brazil
Viviane Belidio Pinheiro da Fonseca: Instituto Nacional de Cardiologia, Rio de Janeiro 22240-006, Brazil
Marcelo Machado Melo: Instituto Nacional de Cardiologia, Rio de Janeiro 22240-006, Brazil
Gabriel Pesce de Castro da Silva: Instituto Nacional de Cardiologia, Rio de Janeiro 22240-006, Brazil
Isabel Cristina Pacheco da Nóbrega: Instituto Nacional de Cardiologia, Rio de Janeiro 22240-006, Brazil
Leonardo Cançado Monteiro Savassi: Departamento de Medicina de Família, Saúde Mental e Coletiva, Universidade Federal de Ouro Preto, Minas Gerais 35400-000, Brazil
Mariana Borges Dias: Ministry of Health, Brasilia 70058-900, Brazil
Maria Kátia Gomes: Departamento de Clínica Médica, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro 21044-020, Brazil
Jose Roberto Lapa e Silva: Departamento de Clínica Médica, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro 21044-020, Brazil
Raphael Mendonça Guimarães: Escola Nacional de Saúde Pública, Rio de Janeiro 21041-210, Brazil
Renato Cony Seródio: Secretaria Municipal de Saúde, Rio de Janeiro 20211-110, Brazil
Anne Frølich: Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, 1353 Copenhagen, Denmark
Henrik Gudbergsen: Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, 1353 Copenhagen, Denmark
Janus Christian Jakobsen: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark & Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, 2200 Copenhagen, Denmark
Helena Dominguez: Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark

IJERPH, 2023, vol. 20, issue 11, 1-16

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.

Keywords: primary health care; telemedicine; heart failure; clinical competence; cluster randomized trial (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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