Improving safety and TReatment precision for Acute COPD Exacerbations: Feasibility trial of a primary care assessment pathway using point-of-care testing (TRACE).

Background Treatment of acute exacerbations of COPD (AECOPDs) accounts for 11.5% of antibiotics prescribed in primary care. Up to 40% of COPD patients have repeated courses of oral corticosteroids (OCS). The decision to prescribe relies on symptoms and examination without test corroboration. For patients with COPD who have already had an exacerbation, prescriptions of drug rescue packs are commonly issued by the GP without clinical assessment and then obtained directly from the pharmacist to ensure the earliest possible intervention. These packs are kept at home for use at the onset of symptoms. Evidence for the effectiveness of antibiotics and OCS prescribed for AECOPDs is equivocal. Both drugs have significant disadvantages and adverse effects, being principally drug resistance in the case of antibiotics, and cataracts, osteoporosis and diabetes caused by OCS. Use of point-of-care tests (POCTs) of serum C-reactive protein (CRP) and blood eosinophil count (BEC) before prescription of these drugs for AECOPDs was associated with decreased prescription of antibiotics by 22% and of OCS by 33%, with no evidence of harm. Providing these POCTs for patients with an AECOPD in local community pharmacies would make the tests immediately accessible. Aims This research will assess the feasibility of conducting a cluster randomised controlled trial (RCT) to evaluate and implement a new assessment pathway for AECOPDs that includes rapid biomarker POCTs in community pharmacies. Feasibility tests include assessment of: the willingness of community pharmacists and general practices to test the new pathway; and the obtaining by COPD patients of rescue packs through prescriptions held by community pharmacists at onset of an AECOPD. In the intervention arm, the provision of the medications at the onset of an AECOPD will be subject to the results of POCTs for antibiotics and OCS. The primary outcome will be the proportion of registered COPD patients with a history of an AECOPD who consent to trial participation and attend the pharmacy for prescription. Secondary outcomes will include the number of AECOPDs reported and observed over six months in participants in both arms. Methods A cluster feasibility RCT will be carried out with clustering at practice level. Ten general practices and associated pharmacies will be randomised, five to the intervention arm (POCT) and five to the control arm (usual care). Participants will be asked to attend the pharmacy at onset of symptoms of an AECOPD. Participants in practices randomised to usual care will be provided a rescue pack. Participants in practices randomised to the intervention arm will be given two POCTs (CRP and blood eosinophil count) to identify participants in whom prescription is not indicated. Participants will be contacted 1 month after attendance at the pharmacy and will be followed up over 6 months after consent. Rates of attendance, POCTs carried out, and drugs prescribed will be compared between intervention and usual care arms using appropriate tests. Dissemination Findings will be disseminated through scientific conferences and high-impact journals. If successful, an application will be made to the NIHR HTA program for a full cluster trial.