CuidAR: reducing hospitalizations and costs with Asthma in Brazil

INTERVENTION: SP1.101.750.121.365 This is an open‐label, parallel, two‐arm (1:1 allocation), cluster‐ randomized, superiority trial. It consists of the implementation and analysis of the effectiveness and cost‐effectiveness of an educational training protocol for asthma management in primary care of the unified health system (Clinical Protocol and Therapeutic Guidelines for Asthma in Brazil, 2021). Participants who have been monitored for at least 3 months in 30 primary health units, covering all macro‐regions of Brazil, will be evaluated. These basic units will be randomly distributed into two groups (15:15), intervention (with educational training for asthma management in primary health care) and control (real‐life usual care). This study will include 1,440 participants aged =6 and =65 years, of both sexes, with a medical diagnosis of uncontrolled asthma. The participants included will be followed up by the study team for 6 months. Their participation will consist in authorizing the collection of clinical and sociodemographic data from their previous outpatient and hospital visits and during the entire follow‐up (3 visits, with completion of questionnaires and assessment of pulmonary function tests ), in addition to responding to telephone interviews carried out by the study team (intervention group). In addition, at the inclusion visit and at each follow‐up visit, participants will complete questionnaires on asthma control and quality of life. In the intervention group, the multidisciplinary team will be trained remotely through distance classes and will be trained on the topics 1) Definition, diagnosis, and risks of asthma; 2) Treatment; and 3) Pulmonary function tests. CONDITION: Asthma PRIMARY OUTCOME: It is expected to find a 50% reduction in the hospitalization rate in the intervention group, evaluated through the number of hospital admissions reported/proved by the research participants. Data will be collected from the 12 months before inclusion in the study and six months after inclusion of the participant in the research INCLUSION CRITERIA: Participants of both sexes, aged between =6 and =65 years at the time of study entry; Medical diagnosis of asthma; Asthma Control Test or Childhood Asthma Control Test with a score < 20; Previous history of two or more episodes of exacerbation; use of bronchodilators and systemic corticosteroids in the last 12 months; Possibility of access by the study team through the patient's personal phone and/or guardians; Patient followed up for at least 3 months in the basic health unit. SECONDARY OUTCOME: A higher percentage of disease control is expected to be observed in the intervention group (score > 20), as measured by the asthma control test applied at inclusion visits and at follow‐up visits It is expected to find a 50% reduction in the number of emergency admissions in the intervention group, as measured by the number of admissions reported/proven by the research participants. Data will be collected 12 months before the intervention and 6 months after the participant's inclusion in the research It is expected to find a 50% reduction in the number of unscheduled visits to the basic health unit in the intervention group, evaluated through the number of visits to the basic health unit without official pre‐scheduling reported/proven by the research participants. Data will be collected 12 months before the intervention and 6 months after the participant's inclusion in the research It is expected to find an improvement in lung function, as assessed by spirometry examination with an increase of at least 5% in respiratory amplitude measured at inclusion visits and at follow‐up visits It is expected to observe a percentage of at least 10% better quality of life in the intervention group, measured using the asthma quality of life questionnaire applied at inclusion and follow‐up visits