Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial

Introduction Bronchiectasis is no longer considered rare or irreversible in children, yet it remains relatively under-researched and neglected in respiratory health globally. Bronchiectasis (including chronic suppurative lung disease) causes substantial morbidity for patients and significant impact...

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Main Authors: Anne B Chang, Peter S Morris, Stephanie T Yerkovich, Julie M Marchant, Anne Cook, Kobi L Schutz, Lesley Versteegh, Jack Roberts
Format: Article
Language:English
Published: BMJ Publishing Group 2021-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/12/e049007.full
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author Anne B Chang
Peter S Morris
Stephanie T Yerkovich
Julie M Marchant
Anne Cook
Kobi L Schutz
Lesley Versteegh
Jack Roberts
author_facet Anne B Chang
Peter S Morris
Stephanie T Yerkovich
Julie M Marchant
Anne Cook
Kobi L Schutz
Lesley Versteegh
Jack Roberts
author_sort Anne B Chang
collection DOAJ
description Introduction Bronchiectasis is no longer considered rare or irreversible in children, yet it remains relatively under-researched and neglected in respiratory health globally. Bronchiectasis (including chronic suppurative lung disease) causes substantial morbidity for patients and significant impact on caregivers, especially during acute respiratory exacerbations. In other chronic respiratory diseases (eg, asthma), empowering consumers with an individualised plan for management of acute exacerbations improves clinical outcomes. However, in the absence of any such data specific to bronchiectasis, action management plans are rarely currently used in children or adults with bronchiectasis. We hypothesise that providing an individualised bronchiectasis action management plan (BAMP) to children with bronchiectasis reduces non-scheduled doctor consultations, compared with not having a BAMP.Methods and analysis This multicentre, parallel, double-blind, randomised trial involving three urban Australian hospitals commenced in June 2018 and will include 198 children, aged <19 years with bronchiectasis who had 2 or more exacerbations in the previous 18 months. Children will be randomised to having an individualised BAMP or standard care (a decoy clinic letter). Primary caregivers will then be followed up monthly for 12 months. The primary outcome is the rate of acute non-scheduled doctor visits for respiratory exacerbations by 12 months. The main secondary outcomes are cough-specific quality of life scores at 6 and 12 months, overall exacerbation rate over 12 months, and proportion of children who received timely influenza vaccination by 30 May annually.Ethics and dissemination The Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Heath Research and Queensland Children’s Hospital approved the study. The results of the trial will be submitted for publication and the BAMP made available free online.Trial registration number Australia and New Zealand Clinical Trials Register ACTRN12618000604202.
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spelling doaj-art-19d1436e4b454c8d86a941c4bb6e71af2025-08-20T02:21:45ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-049007Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trialAnne B Chang0Peter S Morris1Stephanie T Yerkovich2Julie M Marchant3Anne Cook4Kobi L Schutz5Lesley Versteegh6Jack Roberts76 Queensland Children`s Respiratory Centre, Royal Children`s Hospital, Brisbane, Queensland, AustraliaChild and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, AustraliaQueensland Lung Transplant Service, Department of Thoracic Medicine, The Prince Charles Hospital, Chermside, Queensland, AustraliaAustralian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Queensland, AustraliaAustralian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Queensland, AustraliaChild Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, AustraliaChild and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, AustraliaAustralian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Queensland, AustraliaIntroduction Bronchiectasis is no longer considered rare or irreversible in children, yet it remains relatively under-researched and neglected in respiratory health globally. Bronchiectasis (including chronic suppurative lung disease) causes substantial morbidity for patients and significant impact on caregivers, especially during acute respiratory exacerbations. In other chronic respiratory diseases (eg, asthma), empowering consumers with an individualised plan for management of acute exacerbations improves clinical outcomes. However, in the absence of any such data specific to bronchiectasis, action management plans are rarely currently used in children or adults with bronchiectasis. We hypothesise that providing an individualised bronchiectasis action management plan (BAMP) to children with bronchiectasis reduces non-scheduled doctor consultations, compared with not having a BAMP.Methods and analysis This multicentre, parallel, double-blind, randomised trial involving three urban Australian hospitals commenced in June 2018 and will include 198 children, aged <19 years with bronchiectasis who had 2 or more exacerbations in the previous 18 months. Children will be randomised to having an individualised BAMP or standard care (a decoy clinic letter). Primary caregivers will then be followed up monthly for 12 months. The primary outcome is the rate of acute non-scheduled doctor visits for respiratory exacerbations by 12 months. The main secondary outcomes are cough-specific quality of life scores at 6 and 12 months, overall exacerbation rate over 12 months, and proportion of children who received timely influenza vaccination by 30 May annually.Ethics and dissemination The Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Heath Research and Queensland Children’s Hospital approved the study. The results of the trial will be submitted for publication and the BAMP made available free online.Trial registration number Australia and New Zealand Clinical Trials Register ACTRN12618000604202.https://bmjopen.bmj.com/content/11/12/e049007.full
spellingShingle Anne B Chang
Peter S Morris
Stephanie T Yerkovich
Julie M Marchant
Anne Cook
Kobi L Schutz
Lesley Versteegh
Jack Roberts
Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial
BMJ Open
title Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial
title_full Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial
title_fullStr Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial
title_full_unstemmed Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial
title_short Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial
title_sort utility of a personalised bronchiectasis action management plan bamp for children with bronchiectasis protocol for a multicentre double blind parallel superiority randomised controlled trial
url https://bmjopen.bmj.com/content/11/12/e049007.full
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