Feasibility and acceptability of conducting a trial of a C-reactive protein point of care test assisted management strategy for patients presenting with acute exacerbations of chronic obstructive pulmonary disease in UK primary care

Conference: 
SAPC ASM 2015 - Oxford - Evidence and innovation in primary care
Talk Code: 
EP2D.8

The problem

Better targeting of antibiotics for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represents a major opportunity for antimicrobial stewardship. Over 70% of patients presenting with AECOPD in primary care are prescribed an antibiotic. Current antibiotic prescribing recommendations for GPs in the UK are based on symptoms alone. However, these have insufficient diagnostic accuracy to predict which patients can safely be managed without antibiotics.C-reactive protein (CRP) Point-Of-Care Tests (POCTs) are widely available and commonly used to help guide antibiotic prescribing decisions, including for AECOPD in primary care in a number of European countries. However, CRP testing in conjunction with clinical examination has not yet been evaluated. We have developed a CRP algorithm based on best available evidence and consensus statements by a panel of experts. Our main trial will establish whether a CRP-POCT used within the remits of our proposed algorithm can be used to target antibiotic treatment for AECOPD in primary care.However, recruiting participants with acute conditions in primary care is difficult. We therefore conducted a feasibility pilot study to assess recruitment, acceptability, adherence, and retention.

The approach

The study comprises a two-arm individually-randomised trial including patients consulting with an AECOPD in UK primary care. Eligible patients are randomised either to management according to best current practice alone, or to best current practice with the addition of a CRP-POCT.The feasibility study was conducted in 15 practices in Wales over a six month period. The primary aims were to assess recruitment rate, adherence to allocated intervention, and the proportion of patients in whom we are able to measure both co-primary outcomes.Progression onto the full trial requires the following criteria to be met: an average recruitment rate of at least 1.5 participants per practice per month, at least 80% of participants receiving their allocated intervention, and having primary outcome data on at least 80% of participants. We also conducted qualitative evaluations to identify barriers and facilitators to use of the CRP-POCT and participation in the study.

Findings

Recruitment commenced in January 2015, with feasibility assessed in early June 2015. Both quantitative and preliminary qualitative findings from the feasibility study will be presented. We will also highlight any challenges encountered during the set-up of the study, and how these were overcome.Consequence: We will demonstrate the feasibility and acceptability to conduct a trial of CRP-POCT assisted management of patients presenting with AECOPD in primary care. Should feasibility be demonstrated, the main trial will involve recruiting 650 participants from 60 practices across Wales, Oxford, and London, and aim to determine whether or not CRP-POCT assisted management results in a reduction of antibiotic consumption without negatively impacting on health-related quality of life.

Credits

  • David Gillespie, Maastricht University, Maastricht, The Netherlands
  • Nick Francis, Maastricht University, Maastricht, The Netherlands
  • Margaret Barnard, Maastricht University, Maastricht, The Netherlands
  • Jochen Cals, University of South Wales, Pontypridd, UK
  • David Cohen, Oxford University, Oxford, UK
  • Micaela Gal, Maastricht University, Maastricht, The Netherlands
  • Kerenza Hood, Maastricht University, Maastricht, The Netherlands
  • Carlos Llor, University of Tromsø, Tromsø, Norway
  • Hasse Melbye, King’ s College London, London, UK
  • Gurudutt Naik, Maastricht University, Maastricht, The Netherlands
  • Jacqueline Nuttall, Maastricht University, Maastricht, The Netherlands
  • Rhiannon Phillips, Maastricht University, Maastricht, The Netherlands
  • Patrick White, Public Health Wales, Cardiff, UK
  • Mandy Wootton
  • Fasihul Alam, Oxford University, Oxford, UK
  • Janine Bates, Maastricht University, Maastricht, The Netherlands
  • Rachel Breen, Maastricht University, Maastricht, The Netherlands
  • Nigel Kirby, Maastricht University, Maastricht, The Netherlands
  • Amina Singh-Mehta, Maastricht University, Maastricht, The Netherlands
  • Christopher Butler, Primary Healthcare Centre Jaume I, Tarragona, Spain