远程医疗支持稳定型冠状动脉疾病患者从三级医疗机构向初级卫生保健机构的转诊：一项随机非劣效性试验方案

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

作者信息

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

机构信息

Postgraduate Program in Epidemiology. Federal University of Rio Grande do Sul, Porto Alegre, Brazil.

National Institute of Health Technology Assessment (IATS), Porto Alegre, Brazil.

出版信息

BMC Health Serv Res. 2016 Jul 7;16:227. doi: 10.1186/s12913-016-1469-4.

DOI:10.1186/s12913-016-1469-4

PMID:27387752

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4937581/

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.

摘要

背景

许多在三级转诊诊所接受治疗的患有复杂疾病的巴西患者长期病情稳定。这些患者的主要需求包括危险因素监测和药物处方复查，而这些在基层医疗设施中即可得到满意解决。本方案的目的是评估远程医疗服务对支持稳定型慢性冠状动脉疾病患者从三级医疗向基层医疗过渡的安全性和有效性。

方法/设计：我们设计了一项随机非劣效性方案，将纳入280例稳定型冠状动脉疾病患者（病程至少12个月）。患者将从巴西南部一家三级医院的缺血性心脏病诊所选取。入选的参与者将被随机分为两组：一组在同一诊所进行12个月的随访；另一组在基层医疗设施进行12个月的随访，并通过一个包括医生免费热线的远程医疗平台获得临床支持（干预组）。在干预组中，随访期间将患者转诊至三级医疗的决定将由基层医生和医学远程会诊医生共同做出。将对两组在主要结局方面进行比较，即12个月后维持基线功能分级1级或2级。次要结局包括危险因素控制和疾病不稳定性。