Clinical trial NCT02786030: Integrated Primary Care for Chronic Lung Disease: PACK Brazil
Official title: Integrated Primary Care for Chronic Lung Diseases in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit in Brazil (PACK Brazil)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Santa Catarina Federal University
name: University of Cape Town
name: Federal University of Bahia
name: Medical Research Council, South Africa
name: University of East Anglia
First posted: 2016-05-30
Enrollment: 1950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of respiratory care and respiratory health outcomes, and comorbid conditions, in adults with asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 1250 patients known to have been diagnosed with asthma and 700 with COPD in participating clinics and will be included in the study. The primary endpoints for patients with asthma and COPD, respectively, will be composite scores indicating appropriate prescribing and diagnostic testing. The third primary endpoint, among all adult clinic users, will be rates of new diagnoses of asthma and COPD in each clinic. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate management of comorbid conditions such as cardiovascular risk factors. Eligible patients will be identified and outcomes measured using electronic medical records.

Detailed description: Long-lasting lung diseases like asthma and chronic obstructive lung disease (COPD) - collectively called chronic respiratory disease (CRD) - place a heavy and growing burden on people living in low and middle income countries. Many of them could be healthier if their disease was accurately diagnosed and correctly treated, but many are not. Doctors and nurses working in primary health care clinic are best placed people to diagnose and treat CRD, especially where local clinics are near and free. But this raises three questions: 1. How to ensure that CRDs get the priority they need in overloaded clinics? 2. How to train clinicians to diagnose and manage CRDs without special test equipment? 3. How to ensure rational evidence-based diagnosis and prescribing for CRD?

The investigators have developed a way of improving primary health care for people who have CRD, who often also have other long term health conditions. It is a patient management tool (PMT), that is, a printed manual of flowcharts taking doctors and nurses from symptoms to diagnoses to treatments, tests or referrals, with advice on how to make decisions along the way about diagnoses, tests, treatments and referrals. They are prompted to think of other diseases and health problems that might be undetected or neglected. The package also includes a method of training known as outreach education. First trainers are trained, then trainers train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. The investigators' research in Africa has shown that this approach can be effective, cost effective, feasible and sustainable. It has been rolled out throughout South Africa and other African countries. But it has have not yet been shown to be effective for this combination of diseases (CRDs together with cardiovascular disease, diabetes, tuberculosis and back pain). The investigators have also not tried or evaluate it in Latin American countries, which have different health systems, and have many more doctors providing primary health care. Now co-investigators in the Brazilian city of Florianopolis have decided to put this educational package in place throughout the city, and have agreed to do so as a randomised controlled trial. This will clearly show whether PACK Brazil is effective, cost effective and feasible under Brazilian conditions.

The core of the research will be the randomised controlled trial. 48 primary care clinics in the city will be randomly chosen either 1) to get the whole package of patient management tool plus training, or 2) only to get the patient management tool (which we expect will make little difference without training). The investigators will compare patients in these two groups of clinics to see the effects of the training. They will use the clinics' electronic medical records to identify about 2000 adults diagnosed with asthma or COPD. After the training starts they will follow these patients up for a year, and assess whether they are being appropriately treated and tested. They will also compare the rates of new diagnoses of asthma and COPD in each clinic, and various health indicators.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic lower respiratory diseases (ICD10: J40-J47) recorded in electronic medical records since January 1st 2010

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Asthma composite score
timeFrame: During first year of follow-up
measure: COPD composite score
timeFrame: During first year of follow-up
measure: Asthma-or-COPD diagnosis rate
timeFrame: During first year of follow-up
Secondary outcomes:
measure: Hospital admission rate for asthma
timeFrame: During first year of follow-up
measure: Hospital admission rate for COPD
timeFrame: During first year of follow-up
measure: Cardiovascular disease diagnoses
timeFrame: During first year of follow-up
measure: Diabetes mellitus diagnosis
timeFrame: During first year of follow-up
measure: Smoking cessation prescriptions
timeFrame: During first year of follow-up
measure: CVD risk assessment
timeFrame: During first year of follow-up
measure: Depression diagnosis
timeFrame: During first year of follow-up
measure: Depression treatment
timeFrame: During first year of follow-up
measure: Death
timeFrame: During first year of follow-up
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Florianopolis City Health Department
state: Santa Catarina
Study officials:
affiliation: University of East Anglia
name: Max Bachmann, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Eric Bateman, MBChB MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Rafael Stelmach, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick RV, Wattrus C, Anderson L, Georgeu-Pepper D, Lombard C, Fairall LR. Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianopolis, Brazil. BMJ Glob Health. 2019 Dec 16;4(6):e001921. doi: 10.1136/bmjgh-2019-001921. eCollection 2019.
citation: Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick R, Wattrus C, Anderson L, Lombard C, Fairall LR. 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. J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.