Integrated Primary Care for Chronic Lung Disease: PACK Brazil
PACKBrazilR
1 other identifier
interventional
1,950
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 30, 2016
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedApril 27, 2018
April 1, 2018
12 months
May 25, 2016
April 26, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Asthma composite score
For participants with asthma the composite score will comprise points awarded for: i) a first prescription of an inhaled corticosteroid (ICS) or ICS+ long-acting bronchodilator (LABA) combination, or a change in prescription, stepping up from short acting bronchodilator (SABA) to ICS or from ICS to long acting bronchodilator(LABA)+ICS combination; or stepping down from LABA+ICS to ICS, or from ICS to SABA (scoring one point if at least one of these occurs); and ii) request for spirometry (one point). The composite score will be the sum of these points, and will thus range from 0-2. The composite scores for each patient for all visits during the year will be averaged.
During first year of follow-up
COPD composite score
For participants with COPD the composite score with comprise points awarded for: i) a first prescription of SABA, ICS, or ICS+LABA; or a change in prescription, stepping up from SABA to LABA or LABA to ICS+LABA, or stepping down from LABA+ICS to LABA, or from LABA to SABA (scoring one point if at least one of these occurs) and ii) request for spirometry (one point). The composite score will be the sum of these, and will thus also range from 0-2.
During first year of follow-up
Asthma-or-COPD diagnosis rate
Among all participants aged 18 years and over attending each clinic, the number of patients in whom either asthma or COPD is diagnosed for the first time
During first year of follow-up
Secondary Outcomes (9)
Hospital admission rate for asthma
During first year of follow-up
Hospital admission rate for COPD
During first year of follow-up
Cardiovascular disease diagnoses
During first year of follow-up
Diabetes mellitus diagnosis
During first year of follow-up
Smoking cessation prescriptions
During first year of follow-up
- +4 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALDoctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) and outreach education training. First trainers will be trained, then trainers will 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.
Control
ACTIVE COMPARATORDoctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will not receive outreach education training.
Interventions
Printed copies of the patient management tool (PMT) and outreach education training
Printed copies of the patient management tool (PMT) without outreach education training
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of chronic lower respiratory diseases (ICD10: J40-J47) recorded in electronic medical records since January 1st 2010
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulo General Hospitallead
- University of Sao Paulocollaborator
- Santa Catarina Federal Universitycollaborator
- University of Cape Towncollaborator
- Federal University of Bahiacollaborator
- Medical Research Council, South Africacollaborator
- University of East Angliacollaborator
Study Sites (1)
Florianopolis City Health Department
Florianópolis, Santa Catarina, 88.040-400, Brazil
Related Publications (3)
Shekar S, Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Zonta R, Pacheco de Andrade M, Zepeda J, Cornick RV, Wattrus C, Georgeu-Pepper D, Anderson LF, Lombard C, Fairall LR. Effects of PACK training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians during 2 years of implementation in Florianopolis, Brazil: extended follow-up after a pragmatic cluster randomised controlled trial with a stepped-wedge design. BMJ Glob Health. 2024 Oct 28;9(Suppl 3):e013819. doi: 10.1136/bmjgh-2023-013819.
PMID: 39467591DERIVEDBachmann 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.
PMID: 31908865DERIVEDBachmann 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.
PMID: 30174920DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Max Bachmann, MBChB PhD
University of East Anglia
- PRINCIPAL INVESTIGATOR
Eric Bateman, MBChB MD
University of Cape Town
- PRINCIPAL INVESTIGATOR
Rafael Stelmach, MD PhD
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2016
First Posted
May 30, 2016
Study Start
April 1, 2017
Primary Completion
March 31, 2018
Study Completion
March 31, 2019
Last Updated
April 27, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share