PACE study

Hand holding syringe

Assessing whether a simple point of care test can help provide more accurate prescription decisions for patients with chronic obstructive pulmonary disease (COPD).

Background

Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease.

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.

C-reactive protein point-of-care testing (CRP-POCT) is a promising tool to help guide antibiotic treatment decisions, but the use of a CRP POCT to safely guide antibiotic treatment decisions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care has not been previously evaluated.

Acute exacerbations and antibiotics

People with COPD often experience a sudden worsening of symptoms, known as acute exacerbations 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.

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 a likelihood of patient benefit.

A simple finger prick test could help target treatment

C-reactive protein is a protein in the blood that can quickly be measured from a finger prick blood sample using a point of care test. 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. The main challenge in this study is the difficulty in recruiting acutely unwell patients into a study during a busy general practice appointment schedule.

Study design

PACE is a two-arm individually randomised controlled trial.

Patients with acute exacerbations of chronic obstructive pulmonary disease will be randomised to be managed by current best practice (NICE guideline informed) alone or with the addition of a CRP POCT and protocol-based training in test use and interpretation to guide decisions about the use of antibiotic treatment for AECOPD.

A pilot study was carried out in the first six months of the study, during which lessons were learnt in respect of how best to manage the initial consultation and resulted in amendment to the case report forms and eligibility criteria to enable a shorter baseline appointment.

Involving the public and patients

Two representatives from the Involving People organisation sit on the monthly trial management group meetings, one of them being a co-applicant on the study. Their contribution has been invaluable in many aspects and in particular in relation to developing patient materials.

Research impact

The key output will be a clear understanding of the cost-effectiveness of the addition of a CRP POCT to current best clinical practice in improving antibiotic stewardship for AECOPD in primary care.

Funder: Health Technology Assessment (HTA) Programme

Chief Investigators: Professor Chris Butler and Dr Nick Francis