- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02786030
Integrated Primary Care for Chronic Lung Disease: PACK Brazil (PACKBrazilR)
Integrated Primary Care for Chronic Lung Diseases in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit in Brazil (PACK Brazil)
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Matheus Andrade, MD
- Telefonszám: +55 48 3239-1547
- E-mail: mpandradetrabalho@gmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Ronaldo Zonta, MD
- Telefonszám: +55 48 32391545
- E-mail: ronaldozonta@gmail.com
Tanulmányi helyek
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Santa Catarina
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Florianopolis, Santa Catarina, Brazília, 88.040-400
- Toborzás
- Florianopolis City Health Department
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Kapcsolatba lépni:
- Matheus Pacheco de Andrade, MD
- Telefonszám: +55 48 3239-1547
- E-mail: mpandrade.trabalho@gmail.com
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Kapcsolatba lépni:
- Ronaldo Zonta, MD
- Telefonszám: +55 48 3239-1545
- E-mail: ronaldozonta@gmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: 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.
|
A betegkezelési eszköz (PMT) és a megkereső oktatási tréning nyomtatott példányai
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Aktív összehasonlító: Control
Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will not receive outreach education training.
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A betegkezelési eszköz (PMT) nyomtatott példányai tájékoztató képzés nélkül
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Asthma composite score
Időkeret: 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.
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During first year of follow-up
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COPD composite score
Időkeret: During first year of follow-up
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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
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Asthma-or-COPD diagnosis rate
Időkeret: During first year of follow-up
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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
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During first year of follow-up
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Hospital admission rate for asthma
Időkeret: During first year of follow-up
|
Hospital admission rate for asthma in each clinic
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During first year of follow-up
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Hospital admission rate for COPD
Időkeret: During first year of follow-up
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Hospital admission rate for COPD in each clinic
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During first year of follow-up
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Cardiovascular disease diagnoses
Időkeret: During first year of follow-up
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Number of patients with asthma or COPD in whom cardiovascular disease (ICD10 code I00-I99) is diagnosed for the first time
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During first year of follow-up
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Diabetes mellitus diagnosis
Időkeret: During first year of follow-up
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Number of patients with asthma or COPD in whom diabetes mellitus (ICD10 code E10-E14) is diagnosed for the first time
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During first year of follow-up
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Smoking cessation prescriptions
Időkeret: During first year of follow-up
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Number of participants in whom nicotine replacement therapy, nortryptiline, or bupropion are prescribed
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During first year of follow-up
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CVD risk assessment
Időkeret: During first year of follow-up
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Number of participants in whom blood pressure is recorded, or for whom cholesterol, glucose, or electrocardiogram tests are recorded
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During first year of follow-up
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Depression diagnosis
Időkeret: During first year of follow-up
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Number of participants in whom depression (ICD10 code F32-F34) is diagnosed for the first time
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During first year of follow-up
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Depression treatment
Időkeret: During first year of follow-up
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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
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During first year of follow-up
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Death
Időkeret: During first year of follow-up
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Number of participants who died
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During first year of follow-up
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Együttműködők és nyomozók
Együttműködők
Nyomozók
- Kutatásvezető: Max Bachmann, MBChB PhD, University of East Anglia
- Kutatásvezető: Eric Bateman, MBChB MD, University of Cape Town
- Kutatásvezető: Rafael Stelmach, MD PhD, University of Sao Paulo
Publikációk és hasznos linkek
Általános kiadványok
- Bachmann 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.
- Bachmann 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- PACKBrazil1
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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