| Objectives | Outcome measures | Time point(s) of evaluation of this outcome measure |
---|---|---|---|
Primary | To determine whether the addition of a CRP POCT (with training on test use and advice on interpretation) to usual care for managing AECOPD leads to a reduction in antibiotic consumption for AECOPD compared to usual care alone | Antibiotic consumption (any consumption of antibiotics for AECOPD vs. no consumption of antibiotics for AECOPD) | First 4 weeks post randomisation |
Primary | To determine whether the addition of a CRP POCT (with training on test use and advice on interpretation) to usual care for managing AECOPD leads to a reduction in antibiotic consumption for AECOPD without negatively impacting on COPD health status compared to usual care alone | Recovery in terms of COPD health status as assessed using the Clinical COPD Questionnaire (CCQ) total scores | 2 weeks post randomisation |
Secondary | To assess the effect of using a CRP POCT for AECOPD in primary care on: | Prevalence of potentially pathogenic bacteria (including S. pneumoniae, Haemophilus spp. and Enterobacteriacae) cultured from sputum at 4 weeks and the proportion of bacteria that are resistant | 4 weeks post-randomisation |
 |  | Prevalence of commensal organisms cultured from throat swabs at 4 weeks and proportion of bacteria that are resistant | 4 weeks post randomisation |
 |  | COPD health status over time measured using the CCQ total score | At weeks 1, 2 and 4 post randomisation |
 |  | CCQ symptoms domain | At weeks 1, 2 and 4 post randomisation |
 |  | CCQ function state domain | At weeks 1, 2 and 4 post randomisation |
 |  | CCQ mental state domain | At weeks 1, 2 and 4 post randomisation |
 |  | Total antibiotic consumption (number of days antibiotics consumed for AECOPD/any reason) | First 4 weeks post randomisation |
 |  | Health utility measured using the EuroQol-5D (EQ-5D) | At weeks 1, 2 and 4 and at month 6 post randomisation |
 |  | All-cause antibiotic consumption | During the first 4 weeks post randomisation |
 |  | Antibiotic prescribing | At the index consultation |
 |  | Antibiotic prescribing | During the first 4 weeks post randomisation |
 |  | Use of other COPD treatments including orally administered steroids | During the first 4 weeks post randomisation |
 |  | Adverse effects potentially attributable to antibiotics prescribed for the exacerbation | During the first 4 weeks post randomisation |
 |  | Primary and secondary care consultations, including hospitalisations | At week 4 and month 6 |
 |  | Costs (total NHS cost) and cost-effectiveness | At month 6 |
 |  | Incidence of pneumonia (measured by patient and GP report) | At week 4 and month 6 |
 |  | Disease-specific, health-related quality of life over time measured using the CRQ-SAS (dyspnoea, fatigue, emotion function, mastery and total scores) | At month 6 |