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Integrated Primary Care for Chronic Lung Disease: PACK Brazil (PACKBrazilR)

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ClinicalTrials.gov Identifier: NCT02786030
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
University of Sao Paulo
Santa Catarina Federal University
University of Cape Town
Federal University of Bahia
Medical Research Council, South Africa
University of East Anglia
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Behavioral: Outreach education training Behavioral: No outreach education training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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)
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Doctors 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.
Behavioral: Outreach education training
Printed copies of the patient management tool (PMT) and outreach education training

Active Comparator: Control
Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will not receive outreach education training.
Behavioral: No outreach education training
Printed copies of the patient management tool (PMT) without outreach education training




Primary Outcome Measures :
  1. Asthma composite score [ Time Frame: During first year of follow-up ]
    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.

  2. COPD composite score [ Time Frame: During first year of follow-up ]
    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.

  3. Asthma-or-COPD diagnosis rate [ Time Frame: During first year of follow-up ]
    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


Secondary Outcome Measures :
  1. Hospital admission rate for asthma [ Time Frame: During first year of follow-up ]
    Hospital admission rate for asthma in each clinic

  2. Hospital admission rate for COPD [ Time Frame: During first year of follow-up ]
    Hospital admission rate for COPD in each clinic

  3. Cardiovascular disease diagnoses [ Time Frame: During first year of follow-up ]
    Number of patients with asthma or COPD in whom cardiovascular disease (ICD10 code I00-I99) is diagnosed for the first time

  4. Diabetes mellitus diagnosis [ Time Frame: During first year of follow-up ]
    Number of patients with asthma or COPD in whom diabetes mellitus (ICD10 code E10-E14) is diagnosed for the first time

  5. Smoking cessation prescriptions [ Time Frame: During first year of follow-up ]
    Number of participants in whom nicotine replacement therapy, nortryptiline, or bupropion are prescribed

  6. CVD risk assessment [ Time Frame: During first year of follow-up ]
    Number of participants in whom blood pressure is recorded, or for whom cholesterol, glucose, or electrocardiogram tests are recorded

  7. Depression diagnosis [ Time Frame: During first year of follow-up ]
    Number of participants in whom depression (ICD10 code F32-F34) is diagnosed for the first time

  8. Depression treatment [ Time Frame: During first year of follow-up ]
    Number of participants in whom medication for depression (tricyclic and related antidepressants, selective serotonin re-uptake inhibitors, and monoamine oxidase inhibitors) is prescribed for the first time

  9. Death [ Time Frame: During first year of follow-up ]
    Number of participants who died



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786030


Contacts
Contact: Matheus Andrade, MD +55 48 3239-1547 mpandradetrabalho@gmail.com
Contact: Ronaldo Zonta, MD +55 48 32391545 ronaldozonta@gmail.com

Locations
Brazil
Florianopolis City Health Department Recruiting
Florianopolis, Santa Catarina, Brazil, 88.040-400
Contact: Matheus Pacheco de Andrade, MD    +55 48 3239-1547    mpandrade.trabalho@gmail.com   
Contact: Ronaldo Zonta, MD    +55 48 3239-1545    ronaldozonta@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
University of Sao Paulo
Santa Catarina Federal University
University of Cape Town
Federal University of Bahia
Medical Research Council, South Africa
University of East Anglia
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02786030     History of Changes
Other Study ID Numbers: PACKBrazil1
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases