PACE

PACE study video

Background

Diagnostic tests that can be used at the point-of-care to better target antibiotic prescribing for common conditions provide a major opportunity for improving antibiotic stewardship in primary care. About a million people in the UK are diagnosed with COPD, with a probable 2 million more as yet undiagnosed. People with COPD often experience a sudden worsening of symptoms, known as acute exacerbations (AECOPDs), which are typically treated in general practice. AECOPDs are usually treated with antibiotics, although environmental factors and viruses cause many AECOPDs, where antibiotics do not help recovery.

People with COPD frequently express concern that they may be receiving too many antibiotics and that these may be causing them harm. This is particularly important because, in addition to the threats that antimicrobial resistance pose for society as a whole, frequent antibiotics in COPD can generate a population of bacteria in the lungs and elsewhere that become increasingly resistant to antibiotics. This may accelerate progression of the underlying disease and make subsequent AECOPDs harder to treat. However, neither doctors nor patients wish to avoid antibiotics where there is likelihood of patient benefit.

C-reactive protein (CRP)

C-reactive protein (CRP) is a protein in the blood that can quickly be measured from a finger prick blood sample using a ‘point of care test' (POCT). When CRP is low in AECOPD, patients are unlikely to benefit from antibiotics. The PACE study will determine whether GP use of a simple, rapid, one-step CRP POCT in addition to clinical assessment leads to improved antibiotic prescribing decisions for AECOPD in general practice, such that fewer antibiotics are prescribed overall without having adverse effects for patients.

Recruitment

We will recruit 650 patients with AECOPD. Potentially eligible patients will be sent information about the study when general practices register for the study to allow patients to become informed and consider participating before they become unwell with an AECOPD. Those who get an AECOPD and provide consent will be randomly assigned to management using either; 1) current best practice with the addition of a CRP POCT, or 2) current best practice. Participating GPs will be trained in current best practice for AECOPD and interpretation of the CRP POCT results. Antibiotic prescribing decision will be based on clinical judgment, not just the CRP test result. Patients with very severe underlying COPD will not be eligible.

Assessing antibiotic consumption

PACE will determine whether adding the CRP POCT to current best practice reduces antibiotic consumption during the first four weeks after consulting, without negatively impacting on condition specific Health-related Quality of Life, measured at two weeks using the Chronic Respiratory Disease Questionnaire - Self-Administered Standardised. We will also assess whether the CRP-POCT has an impact on the numbers of bacteria resistant to commonly used antibiotics present in sputum at 4 weeks, and symptoms, health-related quality of life, medication, adverse effects, pneumonia requiring hospitalisation, and consultations in primary or secondary health care over the first 4 weeks. We will assess whether the cost of the test can be justified against any improvements in patient care and potential reduction in antibiotic resistance. Interviews with 20 patients and 20 clinicians will gather in-depth feedback on use of the test, which will help plan general uptake should the CRP POCT prove worthwhile.