Impact of Teleconsultation on Patients With Type 2 Diabetes in the Brazilian Public Health System: Protocol for a Randomized Controlled Trial (TELEconsulta Diabetes Trial)

Abstract

Background Although the Brazilian Unified Health System (SUS) offers universal health coverage, access to quality care is often limited by social inequality and location. Although telemedicine has been shown to be an important tool in the efforts to overcome this problem, because it can provide access to specialist care and break the geographical barriers to health care, there are no national studies demonstrating its use in public health. Objective This study aims to test the hypothesis that remote consultation can be as effective as standard face-to-face consultation for type 2 diabetes mellitus in the Brazilian public health system and to assess the associated costs related to teleconsultation in public health scenarios, for patients referred from Primary Health Care units of the SUS for specialist care. Methods This is a pragmatic, phase 2, unicentric, open-label, noninferiority, blinded allocation, data-blinded, centrally randomized clinical trial. The inclusion criteria will be adults, both sexes, ≥18 years old, glycated hemoglobin (HbA1c) ≥8%. Outcomes will be evaluated by assessing symptoms, laboratory exams, anthropometric measurements, blood pressure, adverse events, and satisfaction level for 6 months. The costs of the teleconsultation will be assessed using the time-driven activity-based costing (TDABC) method to compare the costs with the face-to-face consultations. The noninferiority margin was set at 0.5%. Assuming an SD of 1.3% for both groups, true difference between the means of zero, and a type I error level of 5% (one-sided), it was estimated that 117 individuals per group would be necessary to achieve 90% power. Statistical analysis of the efficacy will be done using intention-to-treat and per-protocol approaches. Results The results from this trial will be reported according to the CONSORT guidelines. The trial was approved by the institutional review board on October 5, 2019. Data collection started in January 2019 and is expected to finish in 2022. At the time of manuscript submission, 18 participants were recruited. Conclusions Our expectations are that providing remote access to health care will result in improvements in the health and quality of life of patients with type 2 diabetes and reduce costs and that both patients and clinicians will benefit from and be satisfied with this technology. Trial Registration Registro Brasileiro de Ensaios Clínicos RBR-8gpgyd; https://ensaiosclinicos.gov.br/rg/RBR-8gpgyd International Registered Report Identifier (IRRID) DERR1-10.2196/23679

Description of e-Health Initiatives to Reduce Chronic Non-Communicable Disease Burden on Brazilian Health System

“…As in both cases, the consultation is responsible for more than 90% of the total cost, the difference in duration between the two types of consultation will be the determining factor for the difference in costs between them. More details that relate the methodologic and statistic description are outlined in the design paper published before [ 23 ].…”

“…This project’s main objective, until in recruitment phase, is to conduct clinical research to test the hypothesis that teleconsultation is non-inferior to the face-to-face care of patients with diabetes mellitus (DM) type II referred from primary health care (PHC) to specialized care in SUS [ 23 ].…”

The Quality of Medical Care in the Conditions of the COVID-19 Pandemic, with Particular Emphasis on the Access to Primary Healthcare and the Effectiveness of Treatment in Poland

“…The literature also consistently indicates that in the case of some diseases, telemedicine leads to the improvement of health outcomes. In areas such as type 2 diabetes, research shows that telemedicine intervention is comparable to the standards of traditional medical care and does not cause unnecessary risk or harm to patients [102]. Also, neurological and cardiological signs and simple ophthalmic symptoms such as strabismus can be safely diagnosed and treated through teleconsultation [83,88].…”

Análise dos custos da teleconsulta para tratamento de diabetes mellitus no SUS

“…This is a micro-costing analysis that provides information on the cost of a specialized consultation in remote and in-person modalities, with an endocrinologist, for the treatment of type 2 diabetes, considering the non-inferiority of the teleconsultation mode. The analyses come from patients recruited in a randomized, phase II, pragmatic and non-inferiority clinical trial, whose protocol has already been published previously 14 .…”

“…With recent regulations, studies on the topic at a national level are still incipient. It is in this context, of lack of evidence on the effectiveness of teleconsultation in the country, that the Teleconsultation Project of the Hospital Alemão Oswaldo Cruz (HAOC), a randomized clinical trial (RCT) 14 within the scope of the Program to Support the Institutional Development of the SUS (Proadi-SUS), is situated. Its objective is to test the hypothesis of non-inferiority of teleconsultation compared to in-person consultation in patients with type 2 diabetes, as well as to analyze and compare the costs of the two methods in the SUS; the latter objective is the focus of this article.…”