跳至主要内容
临床试验/NCT04466852
NCT04466852招募中不适用

Otimização do Sistema de Saúde no Brasil Com Telemedicina

University Hospital Bispebjerg and Frederiksberg4 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2020年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
720
试验地点
4
主要终点
composite of all-cause mortality or at least one hospital readmission

研究概览

简要总结

A collaboration gap across sectors is a common problem in Denmark and Brazil. Brazilian Heart Insufficiency with Telemedicine (BRAHIT) will run in parallel with the ongoing Danish Reaching the Frail Elderly project (REAFEL - NCT04162548), supported by the Ministry of Higher Education and Health (Innovationsfonden - Grand Solutions), until 2021. REAFEL seeks a stronger collaboration between primary care and hospital cardiologists to manage frail elderly patients, using teleconsultation and data from mobile devices in Denmark.

Health resources are scarce in Brazil and a pressing need for the Municipal Secretary of Health of Rio de Janeiro is to reduce wait times to access some areas, as cardiology. When patients are stable after undergoing highly complex procedures in a tertiary hospital, are discharged to outpatient treatment at primary care but, a heterogenous expansion of the primary care system in the Rio de Janeiro municipality has created a great resistance from the population, and among cardiologists, to accept continuing cardiology treatment at the primary care system. Enhancing a collaboration between primary care and cardiologists, that is tangible for the patients, can relieve this pressure. The cross-sectorial collaboration in BRAHIT is based on the involvement of Instituto Nacional de Cardiologia (INC), a tertiary cardiology hospital, with primary investigator Aurora Issa (INC) and primary-and homecare in Rio de Janeiro, with primary investigator Leonardo Graever, Primary Care Special Advisor in the Municipality of Rio de Janeiro. The project proposal originates from Denmark and sponsors the project through a Danida grant (Window 2 from the Danish Foreign Ministry - Danida Fellowship Center 18-M03-KU) to the cardiologist Helena Domínguez, as associate professor in the Dept. of Biomedicine, UCPH, and consultant in Bispebjerg-Frederiksberg Hospital.

Being complex public health intervention studies, mixed methods are necessary to evaluate the value gained in the project and to provide research-based policy briefs. The methods include qualitative analyses and a cluster-randomization trial, the latter used for power calculation. Such calculation is based on adequate heart failure medications aggregated in a score constructed for this purpose. Secondary end-point is rate of number of readmissions for any cause, after discharge with heart failure diagnosis.

详细描述

  1. AIM The aim of BRAHIT is to test a new model of care for patients with heart failure in Rio de Janeiro since the investigators can apply well-defined international guidelines for high-quality management of heart failure patients as success criteria, which have been endorsed and adapted in Brazil. Ultimately to provide a policy advice for innovative health management with telemedicine.
  2. BACKGROUND Previous clinical trials that have randomized patients to conventional care or home monitoring with telemedicine solutions have failed to demonstrate a benefit of telemedicine. This is probably due to a selection bias. Accordingly, if only patients with high e-literacy, education and social level are selected for participating in telemedicine studies, it is probable that they have maximum advantage from any treatment, thus making it difficult to assess a benefit with telemedicine. In contrast, weaker patients who truly need a close care remain out of reach for cardiology expertise, remaining under primary care management, with scarce resources.

Another problem is that, once the participants have access to the new healthcare management to be studied, conventional management gets unavoidably changed and comparison is no longer possible. Therefore, in BRAHIT, randomization will not occur at the individual patient level, but through cluster randomization at the organizational level of the primary care clinics. Successful multifaceted programs for heart failure are based on multiple visits to cardiology outpatient clinics, and patients can be safely transferred to Primary Care, but can be too strenuous for frail patients or impossible in remote areas BRAHIT includes quality indicators that allow monitoring quality of care; telemedicine-based tools for patient education, to enhance e-health literacy and innovative communication and data-exchange to support integrated care between health sectors. Telemedicine in BRAHIT can bring cardiology expertise to socially frail patients and, thereby, overcome social inequality.

The Brazilian primary care sector is challenged with long waiting lists for referrals to specialist visits, elective surgeries, and to access higher technology services . This is aggravated in the last years, as Brazil is facing austerity measures.

The Brazilian primary Health Care Model has evolved to almost 60% coverage, based on Family Health Teams, composed by specialized general practitioners, a nurse, nursing technicians and community health agents, while the rest are Family Health Teams with "generalists" (under-graduated physicians).

The municipality of Rio de Janeiro, as it is particularly suitable for this project, with roughly six million habitants and a large social and cultural diversity. About 80% of the population has access to internet, electronic medical records and communication and information technology and Homecare teams are able to use social media and blogs in communicating with the local population. Therefore, it is feasible to use telemedicine communication in association with homecare teams to reach the entire population living in Rio de Janeiro. Furthermore, in BRAHIT, Primary care physicians training programs on heart failure will be based on action mapping, with adaptive technology-enhanced distance learning. 3. METHODS Participants Patients discharged from Instituto Nacional de Cardiologia (INC) with the heart failure as the primary reason for admittance (ICD-10): (DI-11.0, 13.0, 42.0, 42.6, 42.9, 50.0, 50.1, 50.9) and requests from Primary care to INC on questions for management of patients with heart failure diagnosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Discharge from Hospital with one of the following ICD-10 diagnoses: (DI-11.0,-13.0, 42.0, 42.6, 42.9, 50.0, 50.1, 50.9) and follow-up from INC Hospital

排除标准

  • Patients not willing to participate

结局指标

主要结局

composite of all-cause mortality or at least one hospital readmission

时间窗: six months after discharge

Brasilian Heart Insufficiency with Telemedicine score based on changes in multiple parameters. For the subgroup of heart failure with reduced ejection fraction, best condition is 0 points and increasing points indicate worsening, worst 10 points and for the subgroup with preserved ejection fraction best is 0 points and worst is four points.

次要结局

  • health-related quality of life(baseline and six months after discharge)
  • hospital-free days(within 180 days post-discharge)
  • serious adverse events(six months after discharge)
  • heart failure signs and symptoms frequency and intensity(baseline and six months after discharge)

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena DOMINGUEZ

MD, PhD, Associate Professor

University Hospital Bispebjerg and Frederiksberg

研究点 (4)

Loading locations...

相似试验