Title : Endocrinological teleconsultation as a strategy in the brazilian public health system: randomized clinical trial
Brazil has approximately 20 million people with Diabetes Mellitus. Early identification and treatment should be a concern of public authorities, to improve glycemic control and reduce it`s deleterious impacts on the individual's health and consequent cost reduction for health systems. Objective: present the partial results of the Teleconsulta Diabetes trial. This is a randomized clinical trial that evaluates the non-inferiority of endocrinological teleconsultation of patients with type 2 diabetes mellitus in the Brazilian public health system, compared to face-to-face consultation. Method: phase 2, single center, randomized, open study with data analyzed by an independent researcher. Inclusion criteria are adults, both sexes, ≥18 years old, glycated hemoglobin (HbA1c) ≥8%. Outcomes are hypoglycemic symptoms, laboratory, anthropometric measurements, blood pressure, adverse events, and satisfaction level after 6 months. Teleconsultation costs will be assessed using the time-driven activity-based costing 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, a true difference between the means of zero, and a type I error level of 5% (one-sided), it was estimated that 1at 125 individuals per group would be necessary to achieve 90% power. Statistical analysis will be done using intention-to-treat and per-protocol approaches. Results: until Dec/2021, 128 participants were included, 64 in the face-to-face group and 64 in the teleconsultation group. 54.84% are female, the mean age of 61 years. The percentage of participants by race was: 79.03% white, 10.50% black and 9.67% pardos (brown-skinned). The interim analysis of the study is scheduled for July/2022, when participant number 125 (which represents half of the sample) will complete the six months of follow-up required to complete the research. Discussion: in addition to being a model of assistance aimed at the public health system, this study covers a modality of telemedicine, teleconsultation, in which access to the specialist is made directly between the user and the doctor, increasing the capillarity of health, with the potential to have a positive impact on the outcomes of this disease. Conclusion: we expect that providing remote access to health care may result in improvements in the health outcomes and quality of life of patients with type 2 diabetes. Furthermore, it might be possible to provide healthcare rat lower costs taking both patients and clinicians to benefit from this technology. This trial is sponsored by PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SISTEMA Único De Saúde), from Brazilian Ministry of Health.
Audience Take Away:
- This trial can help other physicians and health managers to create new strategies to offer specialized care to diabetic patients.
- How will this help the audience in their job? Is this research that other faculty could use to expand their research or teaching? Does this provide a practical solution to a problem that could simplify or make a designer’s job more efficient? Will it improve the accuracy of a design, or provide new information to assist in a design problem? List all other benefits. This trial could help other researchers to develop new strategies to improve access to specialized care, especially in poor countries.