The trial protocol also includes three sub-studies: 1) using a daily electronic symptom diary capable of picking up symptom defined (but potentially unreported) AECOPD, since these are an important prognostic marker (section 3) 2) collecting sputum samples from patients to assess patterns of antibiotic resistance and 3) a qualitative study which will include staff (for example, healthcare staff delivering the intervention) and patients. There is an internal pilot phase, a detailed process evaluation and a cost-effectiveness study. Use of a chart might reduce antibiotic use, and thus might also change patterns of antibiotic resistance long term, such that these are important secondary outcomes. This study is a pragmatic, individually randomized trial, set in primary care, comparing usual care to the use of a sputum colour chart in patients at risk of hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD), with the hypothesis that use of a colour chart will be non-inferior to usual care with respect to hospital admission rate after 12 months of follow-up, this being the primary outcome measure. Why Should I Register and Submit Results?.
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