Brazilian Heart Insufficiency with Telemedicine (BRAHIT)
The aim of BRAHIT is to showcase a collaboration model between cardiologists and the primary health system regarding management of patients with heart failure in Rio de Janeiro, globalizable to cardiology care in Brazil.
Rationale
Brazil faces challenges in guaranteeing timely and good quality healthcare for all. Health administration in Brazil is divided into planning areas, often formed by existing neighborhoods, and the expansion of the Primary healthcare system has occurred in a heterogeneous way.
The heterogeneity in Primary care, has created a great resistance among the population and among the specialists themselves, to allow patients to be transferred to Primary healthcare. This transfer is further challenged by health professionals being managed by different administrations. This is the case for cardiology care in Rio de Janeiro where the federal authorities (Ministry of Health) are responsible for most of the highly specialized treatment in the hospitals, while municipalities administrate Primary healthcare programs. This leads to fragmentation of the management of patients with heart diseases, resulting in longer waiting times for specialized medical treatment.
Such a sector fragmentation is also an ongoing problem in Denmark, as, like in Brazil, the administration of the hospitals (Danish regions) is not the same as in the Primary sector (municipalities).
We have chosen the case of patients with heart failure because we can apply well-defined international guidelines for high quality management of heart failure patients as success criteria, that have been endorsed, and adapted in Brazil.
Coodinator
The coordinator of the study is Helena Domínguez, Associate Professor in the Danish partner site, the Department of Biomedical Sciences, the Faculty of Health and Medical Sciences, University of Copenhagen, and Consultant in the Cardiology Department of Bispebjerg and Frederiksberg Hospital.
Tasks
- Design of the telemedicine project and elaboration of the research protocol for a clinical trial
- Administration of the budget
- Sub-contracting Danish companies for specific tasks in the project
- Coordination of the partners to achieve the targets
- Coordination of outreach for the general population, for health policies proposals and for publication of scientific results
Partner - Instituto Nacional de Cardiologia (INC)
The partner Instituto Nacional de Cardiologia (INC), Rio de Janeiro, Brazil, is a tertiary hospital for high-specialized treatment of patients with heart disease under the lead of Aurora Issa, Deputy Director of INC. Other investigators in the group are Viviane Belidio and Marcelo Melo.
Tasks
- Submission of the protocol to the Brazilian central Ethics Committee (CONEP)
- Design of the local operation procedures in INC
- Sub-contract of the Primary Care Coordinator, Leonardo Graever, for inclusion of clinics who can participate in the clinical trial and design of data-exchange prototype together with Trifork
- Facilitation of data exchange for heart failure patients from the hospital side
- Facilitation of mobile Palliative Care teams associated to the project
- Elaboration of Master programs for physicians finalizing cardiology specialization
- Qualification of the educational material for patient and caregivers on heart failure
- Qualification of the educational material for doctors in Primary Care elaborated by UFOP
Partner - Universidade Federal de Ouro Preto (UFOP)
The third partner is Universidade Federal de Ouro Preto (UFOP) in the region of Minas Gerais, Brazil, under the lead of Associate Professor Leonardo Savassi.
Sub-contracted Danish Companies
Three Danish companies are sub-contracted in BRAHIT have the following tasks:
- Visikon provides an app solution that uses a simple visual universe to educate patients. In BRAHIT, Visikon elaborates specific education for patients and caregivers, to understand the causes and treatment of heart failure.
- Cortrium provides compact sensors, that are easy for patients to use, for continuous monitoring of heart rhythm.
- Trifork uses their expertise on secure and smooth data exchange across sectors to store in a data-warehouse in BRAHIT, as a model for global use in Brazil. Data are made available to the patients, who can grant permission to healthcare givers to manage their treatment.
The project is funded by the Danida Research Center, from the Ministry of Foreign Office and is conducted with supporting advice from the Daish Embassy in direct collaboration with the Ministry of Health in Brazil.
BRAHIT is basically inspired on the cardio-relay model for shared-care of heart patients currently being applied in another project in Denmark (REAEL – Reaching the Frail Elderly), supported by Grand Solutions, a governmental grant through the Innovation Foundation, Denmark. Elements of REAFEL are directly applied in BRAHIT.
This project aims to improve the management of heart failure in challenged populations.
As in REAFEL, Primary Care doctors request support from the hospital cardiologists on a chat-like function for deciding on need for evaluation and for adjustment on medicine for heart failure. The patients, who may be isolated in areas with difficult access, such as so-called “favelas”, slum quarters in Rio de Janeiro, receive visits from “community agents”, who are neighbors that have received a three-month training to gather observations on the patient condition (pain, breathless, etc.). These community agents make a focused report in the Primary care clinic and return to the patient, for assisting on gathering medications, bringing information, etc. In BRAHIT, Primary Care doctors can communicate with the heart specialists at the Instituto Nacional de Cardiologia hospital (INC) using messaging and teleconferences as needed.
The patients receive heart medicines and educational guidance from their Primary Care doctors, delivered through help from the community agents. These community agents deliver point-of-care devices and sensors during their visits at the patient’s home, that the patient uses to gather information on blood pressure, weight, heart rhythm, etc., that allows Primary Care doctors to adjust the treatment. Mobile Palliative Care teams who deliver specialized home-care are involved and guided by the cardiologist team in the same telemedicine platform in BRAHIT.
Online educational programs for Primary Care doctors, elaborated by the UFOP team, are qualified by the project coordinator and the INC cardiologists. These programs are made available for Primary Care on demand.
BRAHIT applies mixed methods to provide evidence on how successful is BRAHIT for this purpose. This includes ethnographic studies on site, a pilot phase, to make the model feasible, followed by cluster-randomization of Primary Care units stratified according to units with certified Family doctors and units with non-specialized doctors. Clusters are randomized to use of the cardio-relay model or conventional care, where community agents also are involved in patient support.
The general hypothesis in BRAHIT is that the cardio-relay collaboration model, using telemedicine aid, can improve the quality of care management of chronic heart disease, and reach out to weak patients.
Clinical trial
In the cluster-randomization phase of the project, we test the hypothesis that the proportion of patients receiving correct heart medications for heart failure will increase from 30% to 60% in patients managed according to the BRAHIT model. Furthermore, we hypothesize, that use of the BRAHIT model will result in a reduction of readmissions for heart failure in 90 days after discharge from 50% (current proportion of readmissions) to 30% (secondary end-point).
Follow-up
To quantify use of target medications, we construct a BRAHIT score based on changes of clinical parameters, where best condition is 0 points and increasing points indicate worsening.
- NYHA: improved or I (0 points) / no improvement (1 point) / worsening (2 points)
- Weight: closer to target or on-target (0 points) / no change +/- 1.9 Kg since last measurement (1 point), increase 2 Kg or more (2 points)
- ACE-I/ARB: Target dose (0 points) / tried but not reached target or not tolerated (1 point) / Never used (2 points)
- Betablockers: Target dose (0 points) / tried but not reached target or not tolerated (1 point) / Never used (2 points)
- Mineralocorticoid antagonist: Target dose or not indicated (0 points) / tried but not reached target or not tolerated (1 point) / Never used (2 points)
We will register prospectively available success parameters for heart failure management, that includes the components of the BRAHIT score at baseline, and after six and 12 months. Moreover, we will collect the following additional parameters:
- Use of loop diuretics and thiazides
- Occurrence of fainting
- Hospital admission
- Occurrence of atrial fibrillation
- Cardiac death
- Death of any cause, including unknown cause
Each patient record will have the option “unknown”, when no data are available at each follow-up timepoint, to provide an indicator for data quality in the trial.
Participants experience
Patient experience is analyzed through semi-structured interviews based on responses to a brief questionnaire to reveal patient-reported outcomes.
Clinicians experience will be analyzed from focus groups interviews with participants in the study, gathering a group of cardiologists, primary care certified and non-certified Family doctors, Primary care nurses and Community agents.
e-Health literacy studies on patients with heart failure and increased knowledge in Primary Care will be pursued but are beyond the targets of BRAHIT.
