title: Telemedicine-supported transition of stable coronary artery disease patients from tertiary to primary health care facilities: protocol for a randomized non-inferiority trial.
abstract: Many Brazilian patients with complex diseases who are treated in tertiary referral clinics have been stable for long periods. The main needs of these patients involve monitoring of risk factors and review of drug prescriptions, which could be satisfactorily done in primary care facilities. The goal of this protocol is to evaluate the safety and effectiveness of telemedicine services to support the transition of patients with stable chronic coronary artery disease from the tertiary to the primary level of care.
  
  
  
  We designed a randomized non-inferiority protocol that will include 280 patients with stable coronary artery disease (for at least 12 months). Patients will be selected from the Ischemic Heart Disease Clinic in a tertiary care hospital in southern Brazil. Enrolled participants will be randomized into one of two groups: 12 months of follow-up at the same clinic; or 12 months of follow-up at a primary care facility with clinical support from a telemedicine platform including a toll-free line for physicians (intervention group). In the intervention group, decisions to refer patients to tertiary care during follow-up will be made jointly by primary physicians and medical teleconsultants. The groups will be compared in terms of the primary outcome-maintenance of baseline functional class 1 or 2 after 12 months. Secondary outcomes include control of risk factors and instability of the disease.
  
  
  
  We intend to determine the effectiveness of using telemedicine to qualify the transition of patients with chronic coronary disease from the tertiary to the primary level of care. This should facilitate the access of patients to the healthcare system, since care will be provided closer to their homes, and provide more opportunities for treatment of severe cases at tertiary care hospitals that are often overcrowded.
  
  
  
  ClinicalTrials.gov # NCT02489565 - trial registration date May 13, 2015.
authors.affiliation: Postgraduate Program in Epidemiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil. joannalyra@gmail.com.|National Institute of Health Technology Assessment (IATS), Porto Alegre, Brazil. joannalyra@gmail.com.|Instituto de Avaliação de Tecnologia em Saúde, Hospital de Clínicas de Porto Alegre - Centro de Pesquisas Clínicas, Rua Ramiro Barcelos, 2359 prédio 21 sala 507, Porto Alegre, RS, CEP: 90035-903, Brazil. joannalyra@gmail.com.
authors.forename: Joanna d'Arc Lyra
authors.initials: Jd
authors.lastname: Batista
authors.affiliation: National Institute of Health Technology Assessment (IATS), Porto Alegre, Brazil.|Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
authors.forename: Mariana Vargas
authors.initials: MV
authors.lastname: Furtado
authors.affiliation: Postgraduate Program in Epidemiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
authors.forename: Natan
authors.initials: N
authors.lastname: Katz
authors.affiliation: Postgraduate Program in Epidemiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
authors.forename: Milena Rodrigues
authors.initials: MR
authors.lastname: Agostinho
authors.affiliation: Postgraduate Program in Epidemiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil.|Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
authors.forename: Brasil Silva
authors.initials: BS
authors.lastname: Neto
authors.affiliation: Postgraduate Program in Epidemiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil.|National Institute of Health Technology Assessment (IATS), Porto Alegre, Brazil.
authors.forename: Erno
authors.initials: E
authors.lastname: Harzheim
authors.affiliation: Postgraduate Program in Epidemiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil.|National Institute of Health Technology Assessment (IATS), Porto Alegre, Brazil.|Postgraduate Program in Cardiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
authors.forename: Carisi Anne
authors.initials: CA
authors.lastname: Polanczyk
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D001938:Brazil; D002908:Chronic Disease; D003324:Coronary Artery Disease / Q000628:therapy; D011320:Primary Health Care; D012017:Referral and Consultation; D012107:Research Design; D012307:Risk Factors; D017216:Telemedicine; D062606:Tertiary Care Centers; D000069341:Transitional Care; D000074099:Equivalence Trials as Topic
keywords: Coronary artery disease; Randomized clinical trial; Telemedicine