- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Matheus Andrade, MD
- Numéro de téléphone: +55 48 3239-1547
- E-mail: mpandradetrabalho@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Ronaldo Zonta, MD
- Numéro de téléphone: +55 48 32391545
- E-mail: ronaldozonta@gmail.com
Lieux d'étude
-
-
Santa Catarina
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Florianopolis, Santa Catarina, Brésil, 88.040-400
- Recrutement
- Florianopolis City Health Department
-
Contact:
- Matheus Pacheco de Andrade, MD
- Numéro de téléphone: +55 48 3239-1547
- E-mail: mpandrade.trabalho@gmail.com
-
Contact:
- Ronaldo Zonta, MD
- Numéro de téléphone: +55 48 3239-1545
- E-mail: ronaldozonta@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Copies imprimées de l'outil de gestion des patients (PMT) et de la formation d'éducation de proximité
|
Comparateur actif: Control
Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will not receive outreach education training.
|
Copies imprimées de l'outil de gestion des patients (PMT) sans formation d'éducation de proximité
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Asthma composite score
Délai: 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.
|
During first year of follow-up
|
COPD composite score
Délai: 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.
|
During first year of follow-up
|
Asthma-or-COPD diagnosis rate
Délai: 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
|
During first year of follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hospital admission rate for asthma
Délai: During first year of follow-up
|
Hospital admission rate for asthma in each clinic
|
During first year of follow-up
|
Hospital admission rate for COPD
Délai: During first year of follow-up
|
Hospital admission rate for COPD in each clinic
|
During first year of follow-up
|
Cardiovascular disease diagnoses
Délai: 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
|
During first year of follow-up
|
Diabetes mellitus diagnosis
Délai: 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
|
During first year of follow-up
|
Smoking cessation prescriptions
Délai: During first year of follow-up
|
Number of participants in whom nicotine replacement therapy, nortryptiline, or bupropion are prescribed
|
During first year of follow-up
|
CVD risk assessment
Délai: 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
|
During first year of follow-up
|
Depression diagnosis
Délai: During first year of follow-up
|
Number of participants in whom depression (ICD10 code F32-F34) is diagnosed for the first time
|
During first year of follow-up
|
Depression treatment
Délai: 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
|
During first year of follow-up
|
Death
Délai: During first year of follow-up
|
Number of participants who died
|
During first year of follow-up
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Max Bachmann, MBChB PhD, University of East Anglia
- Chercheur principal: Eric Bateman, MBChB MD, University of Cape Town
- Chercheur principal: Rafael Stelmach, MD PhD, University of São Paulo
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PACKBrazil1
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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