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 Florianópolis, Brazil

Abstract

Introduction: The Practical Approach to Care Kit (PACK) guide was localised for Brazil, where primary care doctors and nurses were trained to use it.

Methods: Twenty-four municipal clinics in Florianópolis were randomly allocated to receive outreach training and the guide, and 24 were allocated to receive only the guide. 6666 adult patients with asthma or chronic obstructive pulmonary disease (COPD) were enrolled, and trial outcomes were measured over 12 months, using electronic medical records. The primary outcomes were composite scores of treatment changes and spirometry, and new asthma and COPD diagnosis rates.

Results: Asthma scores in 2437 intervention group participants were higher (74.8%, 20.4% and 4.8% with scores of 0, 1 and 2, respectively) than in 2633 control group participants (80.0%, 16.8% and 3.2%) (OR for higher score 1.32, 95% CI 1.08 to 1.61, p=0.006). Adjusted for asthma scores recorded in each clinic before training started, the OR was 1.24 (95% CI 1.03 to 1.50, p=0.022). COPD scores in 1371 intervention group participants (77.7%, 17.9% and 4.3% with scores of 0, 1 and 2) did not differ from those in 1181 control group participants (80.5%, 15.8% and 3.7%) (OR 1.21, 95% CI 0.94 to 1.55, p=0.142). Rates of new asthma and COPD diagnoses, and hospital admission, and indicators of investigation, diagnosis and treatment of comorbid cardiovascular disease, diabetes and depression, and tobacco cessation did not differ between trial arms.

Conclusion: PACK training increased guideline-based treatment and spirometry for asthma but did not affect COPD or comorbid conditions, or diagnosis rates.

Trial registration: NCT02786030 (https://clinicaltrials.gov/).

Keywords: educational outreach; implementation research; primary care; respiratory disease.

Conflict of interest statement

Competing interests: We have read and understood BMJ policy on declaration of interests and declare that CW, LRF, DG-P, LA, RVC and EDB are employees of the KTU. RZ and MPdA are employees of the City Health Department, Florianópolis, Brazil. JZ is an ex-employee of the City Health Department, Florianópolis, Brazil and a current holder of full-time PhD studentship from the Brazilian research agency CNPq. AAC reports grants, personal fees and non-financial support from GSK, personal fees and non-financial support from AstraZeneca, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from MEDA, personal fees and non-financial support from Novartis, personal fees and non-financial support from EUROFARMA, personal fees and non-financial support from CHIESI, personal fees and non-financial support from Boston Scientific, outside the submitted work. EDB reports grants to institution for clinical trials from Novartis, Boehringer Ingelheim, Merck, Takeda, GlaxoSmithKline, Hoffmann La Roche, Actelion, Chiesi, Sanofi-Aventis, Cephalon, TEVA and AstraZeneca and personal fees from ICON, Novartis, Cipla, Vectura, Cipla, Menarini, ALK, ICON, Sanofi Regeneron, Boehringer Ingelheim and AstraZeneca, outside the submitted work, and is a Member of Global Initiative for Asthma Board and Science Committee. RS reports grants for clinical trials, personal, institution fees and non-financial support from AstraZeneca, and personal fees and non-financial support from Novartis, Boehringer Ingelheim, CHIESI and EUROFARMA. Since August 2015, the KTU and BMJ have been engaged in a non-profit strategic partnership to provide continuous evidence updates for PACK, expand PACK-related supported services to countries and organisations as requested, and where appropriate license PACK content. The KTU and BMJ co-fund core positions, including a PACK Global Development Director, and receive no profits from the partnership. PACK receives no funding from the pharmaceutical industry. This paper forms part of a Collection on PACK sponsored by the BMJ to profile the contribution of PACK across several countries towards the realisation of comprehensive primary health care as envisaged in the Declarations of Alma Ata and Astana.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Timing of interventions, data collection and follow-up periods.

Figure 2

CONSORT diagram of recruitment and follow-up in intervention and control clinics. COPD, chronic obstructive pulmonary disease.