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J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.

Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials.

Author information

1
Norwich Medical School, University of East Anglia, Norwich, UK.
2
University of Cape Town, Cape Town, South Africa.
3
University of Sao Paulo, Sao Paulo, Brazil.
4
Federal University of Bahia, Salvador, Brazil.
5
City Health Department, Florianopolis, Brazil.
6
University of Leeds, Leeds, UK.
7
Federal University of Santa Catarina, Florianopolis, Brazil.
8
Medical Research Council, Cape Town, South Africa.

Abstract

Background:

Multimorbidity is increasing common in Brazilian adults. Comorbid chronic lung disease, cardiovascular disease and diabetes are often inaccurately diagnosed or ineffectively treated. The Global Alliance against Chronic Respiratory Diseases (GARD) aims to strengthen health systems to prevent and control non-communicable diseases through primary health care. The Practical Approach to Care Kit (PACK Adult) is a clinical decision support tool that provides evidence-supported algorithmic guidelines for screening, diagnosis and treatment of chronic diseases, and is widely used in South Africa. It was adapted for Brazil by family physicians in the Florianopolis City Health Department, which trains clinic doctors and nurses to use it.

Methods:

Effectiveness of PACK Adult training will be evaluated in two pragmatic cluster randomised trials, one enrolling adults with chronic lower respiratory diseases and the other enrolling adults with cardiovascular disease or diabetes. Forty-eight municipal clinics in Florianopolis were randomly allocated to intervention or control arms. In intervention arm clinics, doctors and nurses will receive educational outreach training and the PACK Adult clinical decision support tool. In control arm clinics, doctors and nurses will receive only the tool. Trial outcomes will be measured using patients' electronic medical records during 12 months after completion of basic training. Primary outcomes for the respiratory trial are appropriate prescribing, spirometry and diagnosis rates. Primary outcomes for the cardiovascular trial are testing for cardiovascular risk and diabetes, and systolic blood pressure. Educational outreach to primary care professionals could improve respiratory, cardiovascular and diabetes care in Brazil.

Trial registration:

NCT02786030 and NCT02795910 (https://clinicaltrials.gov/).

KEYWORDS:

Primary health care; asthma; cardiovascular disease (CVD); chronic obstructive pulmonary disease (COPD); diabetes; randomised controlled trial (RCT)

Conflict of interest statement

Conflicts of Interest: The Florianopolis City Health Department has a non-financial interest, and the KTU and BMJ Publishing have a financial interest, in the intervention being shown to be effective. The KTU and BMJ Publishing have entered into a non-profit partnership to explore ways of making annual revisions of the PACK CDST and associated materials globally available, and to provide mentorship support to in-country teams wishing to localise it for their settings. The authors declare that they have no other competing interests.

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