Telemedicine-supported transition of stable coronary artery disease patients from tertiary to primary health care facilities: protocol for a randomized non-inferiority trial

Joanna d'Arc Lyra Batista, Mariana Vargas Furtado, Natan Katz, Milena Rodrigues Agostinho, Brasil Silva Neto, Erno Harzheim, Carisi Anne Polanczyk, Joanna d'Arc Lyra Batista, Mariana Vargas Furtado, Natan Katz, Milena Rodrigues Agostinho, Brasil Silva Neto, Erno Harzheim, Carisi Anne Polanczyk

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov # NCT02489565 - trial registration date May 13, 2015.

Keywords: Coronary artery disease; Randomized clinical trial; Telemedicine.

Figures

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Fig. 1
Flow Diagram of Study Design

References

    1. Weil BR and Canty Jr JM. Coronary Blood Flow and Myocardial Ischemia. Essential Cardiology. 2013;doi:10.1007/978%E2%80%931%E2%80%934614%E2%80%936705%E2%80%932_22.
    1. Bueno FR, Correa FR, Alves MAS, Bardin MG, Modesto JA, Dourado VZ. Physical exercise capacity and its prognostic value in postoperative cardiac surgery [Portuguese] Fisioter Mov. 2012;25(4):839–47. doi: 10.1590/S0103-51502012000400017.
    1. Mattos LAIP, Berwanger O, Santos ES, Reis HJL, Romano ER, Petriz JLF, et al. Desfechos clínicos aos 30 dias do registro brasileiro das síndromes coronárias agudas (ACCEPT) Arq Bras Cardiol. 2013;100(1):6–13. doi: 10.1590/S0066-782X2013000100003.
    1. Starfield B. Basic concepts in population health and health care. J Epidemiol Community Health. 2011;55:452–54. doi: 10.1136/jech.55.7.452.
    1. Starfield B. Primary care: an increasingly important contributor to effectiveness, equity, and efficiency of health services SESPAS report. Gac Sanit. 2012;26(1):20–6. doi: 10.1016/j.gaceta.2011.10.009.
    1. Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, et al. ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012;126(25):e354–471. doi: 10.1161/CIR.0b013e318277d6a0.
    1. Brazil. Ministry of Health. Portaria n. 2546, 2011. . Accessed 25 June 2015.
    1. Cesar LA, Ferreira JF, Armaganijan D, Gowdak LH, Mansur AP, Bodanese L, et al. Guideline for Stable Coronary Artery Disease. Arq Bras Cardiol. 2014;103(2):1–56. doi: 10.5935/abc.2014S004.
    1. Wilson SR, Scirica BM, Braunwald E, Murphy SA, Karwatowska-Prokopczuk E, Buros JL, et al. Efficacy of ranolazine in patients with chronic angina observations from the randomized, double-blind, placebo-controlled MERLIN-TIMI (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Segment Elevation Acute Coronary Syndromes) 36 Trial. J Am Coll Cardiol. 2009;53(17):1510–6. doi: 10.1016/j.jacc.2009.01.037.
    1. Canadian Cardiovascular Society Functional Classification of Angina. Cardiovascular Disability: Updating the Social Security Listings. 2010. . Accessed 20 July 2015.
    1. Damasceno F, Reategui E, Schmitz CAA, Harzheim E, Epstein D. Supporting Teleconsulting with Text Mining: Continuing Professional Development in the TelehealthRS Project In: Collaboration and Technology. Berlin: Springer; 2014. pp. 97–104.
    1. U.S. Department of Health and Human Services, National Institutes of Health. NIH Publication n. 05–3290. 2005. . Accessed 13 July 2015
    1. Fratini JG, Saupe R, Massaroli A. Referência e contra referência: contribuição para a integralidade em saúde. Cienc Cuid Saude. 2008;7(1):65–72.
    1. Davis DA, Thomson MA, Oxman AD, Haynes RB. Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA. 1995;274(9):700–5. doi: 10.1001/jama.1995.03530090032018.
    1. Gusso G, Lopes JMC. Tratado de Medicina de Família e Comunidade – 2 Volumes: Princípios, Formação e Prática. 1. Porto Alegre: Artmed; 2012.

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