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Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial

Anke Lenferink, Job van der Palen, Paul D.L.P.M. van der Valk, Paul Cafarella, Anneke van Veen, Stephen Quinn, Catharina G.M. Groothuis-Oudshoorn, Morton G. Burt, Mary Young, Peter A. Frith, Tanja W. Effing
European Respiratory Journal 2019 54: 1802134; DOI: 10.1183/13993003.02134-2018
Anke Lenferink
1Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands
2Dept of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands
3College of Medicine and Public Health, Flinders University, Adelaide, Australia
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  • For correspondence: a.lenferink@mst.nl
Job van der Palen
1Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands
4Dept of Research Methodology, Measurement, and Data-Analysis, Faculty of Behavioural, Management and Social Sciences, University of Twente, Enschede, The Netherlands
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Paul D.L.P.M. van der Valk
1Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands
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Paul Cafarella
3College of Medicine and Public Health, Flinders University, Adelaide, Australia
5Dept of Respiratory Medicine, Southern Adelaide Local Health Network, Adelaide, Australia
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Anneke van Veen
6Dept of Pulmonary Medicine, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands
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Stephen Quinn
7Dept of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia
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Catharina G.M. Groothuis-Oudshoorn
2Dept of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands
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Morton G. Burt
3College of Medicine and Public Health, Flinders University, Adelaide, Australia
8Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Adelaide, Australia
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Mary Young
9Dept of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, Australia
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Peter A. Frith
3College of Medicine and Public Health, Flinders University, Adelaide, Australia
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  • ORCID record for Peter A. Frith
Tanja W. Effing
3College of Medicine and Public Health, Flinders University, Adelaide, Australia
5Dept of Respiratory Medicine, Southern Adelaide Local Health Network, Adelaide, Australia
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Abstract

This international randomised controlled trial evaluated whether COPD patients with comorbidities, trained in using patient-tailored multidisease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).

COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification II–IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression) were randomised to a patient-tailored self-management intervention (n=102) or UC (n=99). Daily symptom diaries were completed for 12 months. The primary outcome “COPD exacerbation days per patient per year” was assessed using intention-to-treat analyses.

No significant difference was observed in the number of COPD exacerbation days per patient per year (self-management: median 9.6 (interquartile range (IQR) 0.7–31.1); UC: median 15.6 (IQR 3.0–40.3); incidence rate ratio (IRR) 0.87 (95% CI 0.54; 1.39); p=0.546). There was a significantly shorter duration per COPD exacerbation for self-management (self-management: median 8.1 (IQR 4.8–10.1) days; UC: median 9.5 (IQR 7.0–15.1) days; p=0.021), with no between-group differences in the total number of respiratory hospitalisations (IRR 0.76 (95% CI 0.42; 1.35); p=0.348), but a lower probability of ≥1 for respiratory-related hospitalisation compared to UC (relative risk 0.55 (95% CI 0.35; 0.87); p=0.008). No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); relative risk 0.55 (95% CI 0.17; 1.84)).

Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.

Abstract

Patient-tailored exacerbation action plans for COPD patients with comorbidities do not reduce exacerbation days, but reduce exacerbation duration and risk of having at least one respiratory-related hospitalisation during follow-up, without excess mortality http://bit.ly/2Mi8Fhc

Footnotes

  • This study is registered in the public Australian New Zealand Clinical Trials Registry (ACTRN12612000514808). All relevant data are presented within the paper and its supplementary files. All data are from the COPE-III study, whose authors may be contacted at Medisch Spectrum Twente, Dept of Pulmonary Disease, Enschede, The Netherlands. A copy of the patient-tailored diary and action plan can be requested from the corresponding author. Furthermore, detailed methods including a statistical analysis plan are published elsewhere.

  • This article has supplementary material available from erj.ersjournals.com

  • Support statement: This study was supported by the Lung Foundation Netherlands (grant number 3.4.11.061), Lung Foundation Australia (Australian Lung Foundation Boehringer Ingelheim COPD Research Fellowship 2010), Repat Foundation, GlaxoSmithKline (unrestricted grant) and Stichting Astma Bestrijding. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Conflict of interest: A. Lenferink reports grants from Stichting Astmabestrijding (SAB) and GlaxoSmithKline (unrestricted grant), during the conduct of the study.

  • Conflict of interest: J. van der Palen reports grants from Netherlands Lung Foundation, during the conduct of the study.

  • Conflict of interest: P.D.L.P.M. van der Valk has nothing to disclose.

  • Conflict of interest: P. Cafarella has nothing to disclose.

  • Conflict of interest: A. van Veen has nothing to disclose.

  • Conflict of interest: S. Quinn has nothing to disclose.

  • Conflict of interest: C.G.M. Groothuis-Oudshoorn has nothing to disclose.

  • Conflict of interest: M.G. Burt has nothing to disclose.

  • Conflict of interest: M. Young has nothing to disclose.

  • Conflict of interest: P.A. Frith has nothing to disclose.

  • Conflict of interest: T.W. Effing reports grants from The Repat Foundation, Australian Lung Foundation and Dutch Asthma Foundation, during the conduct of the study.

  • Received April 6, 2018.
  • Accepted July 22, 2019.
  • Copyright ©ERS 2019
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Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial
Anke Lenferink, Job van der Palen, Paul D.L.P.M. van der Valk, Paul Cafarella, Anneke van Veen, Stephen Quinn, Catharina G.M. Groothuis-Oudshoorn, Morton G. Burt, Mary Young, Peter A. Frith, Tanja W. Effing
European Respiratory Journal Nov 2019, 54 (5) 1802134; DOI: 10.1183/13993003.02134-2018

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Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial
Anke Lenferink, Job van der Palen, Paul D.L.P.M. van der Valk, Paul Cafarella, Anneke van Veen, Stephen Quinn, Catharina G.M. Groothuis-Oudshoorn, Morton G. Burt, Mary Young, Peter A. Frith, Tanja W. Effing
European Respiratory Journal Nov 2019, 54 (5) 1802134; DOI: 10.1183/13993003.02134-2018
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