Integrated Primary Care for Chronic Lung Disease: PACK Brazil

Asthma Clinical Trial

— PACKBrazilR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02786030
• Other study ID #: PACKBrazil1
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2016
• Last updated: April 26, 2018
• Start date: April 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2018
• Source: University of Sao Paulo General Hospital
• Contact: Matheus Andrade, MD
• Phone: +55 48 3239-1547
• Email: mpandradetrabalho[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1950
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Outreach education training
Printed copies of the patient management tool (PMT) and outreach education training
• No outreach education training
Printed copies of the patient management tool (PMT) without outreach education training

Locations

Country	Name	City	State
Brazil	Florianopolis City Health Department	Florianopolis	Santa Catarina

Sponsors (7)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Federal University of Bahia, Medical Research Council, South Africa, Santa Catarina Federal University, University of Cape Town, University of East Anglia, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Hospital admission rate for asthma	Hospital admission rate for asthma in each clinic	During first year of follow-up
Secondary	Hospital admission rate for COPD	Hospital admission rate for COPD in each clinic	During first year of follow-up
Secondary	Cardiovascular disease diagnoses	Number of patients with asthma or COPD in whom cardiovascular disease (ICD10 code I00-I99) is diagnosed for the first time	During first year of follow-up
Secondary	Diabetes mellitus diagnosis	Number of patients with asthma or COPD in whom diabetes mellitus (ICD10 code E10-E14) is diagnosed for the first time	During first year of follow-up
Secondary	Smoking cessation prescriptions	Number of participants in whom nicotine replacement therapy, nortryptiline, or bupropion are prescribed	During first year of follow-up
Secondary	CVD risk assessment	Number of participants in whom blood pressure is recorded, or for whom cholesterol, glucose, or electrocardiogram tests are recorded	During first year of follow-up
Secondary	Depression diagnosis	Number of participants in whom depression (ICD10 code F32-F34) is diagnosed for the first time	During first year of follow-up
Secondary	Depression treatment	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	During first year of follow-up
Secondary	Death	Number of participants who died	During first year of follow-up