Rapid respiratory microbiological point-of-care-testing and antibiotic prescribing in primary care: Protocol for the RAPID-TEST randomised controlled trial

Samantha Elizabeth Abbs*, Lindsay Armstrong-Buisseret, Kathy Eastwood, Stephen Granier, Athene Lane, Mandy Lui, Chris Metcalfe, Paul Mitchell, Peter Muir, Matthew Ridd, Jodi Taylor, Lucy Yardley, Grace Young, Alastair D Hay

*Corresponding author for this work

Research output: Contribution to journalProtocol

Abstract

Background:
Antibiotics are prescribed for over 50% of respiratory tract infections in primary care, despite good evidence of there being no benefit to the patient, and evidence of over prescribing driving microbial resistance. The high treatment rates are attributed to uncertainty regarding microbiological cause and clinical prognosis. Point-of-care-tests have been proposed as potential antibiotic stewardship tools, with some providing microbiological results in 15 minutes. However, there is little research on their impact on antibiotic use and clinical outcomes in primary care.

Methods:
This is a multi-centre, individually randomised controlled trial with mixed-methods investigation of microbial, behavioural and antibiotic mechanisms on outcomes in patients aged 12 months and over presenting to primary care in the UK with a suspected respiratory tract infection, where the clinician and/or patient thinks antibiotic treatment may be, or is, necessary. Once consented, all participants are asked to provide a combined nose and throat swab sample and randomised to have a rapid microbiological point-of-care-test or no point-of-care-test. For intervention patients, clinicians review the result of the test, before contacting the patient to finalise treatment. Treatment decisions are made as per usual care in control group patients. The primary outcome is whether an antibiotic is prescribed at this point. All swab samples are sent to the central laboratory for further testing. Patients are asked to complete a diary to record the severity and duration of symptoms until resolution or day 28, and questionnaires at 2 months about their beliefs and intention to consult for similar future illnesses. Primary care medical records are also reviewed at 6-months to collect further infection consultations, antibiotic prescribing and hospital admissions. The trial aims to recruit 514 patients to achieve 90% power with 5% significance to detect a 15% absolute reduction in antibiotic prescribing. Qualitative interviews are being conducted with approximately 20 clinicians and 30 participants to understand any changes in beliefs and behaviour resulting from the point-of-care-test and generate attributes for clinician and patient discrete choice experiments.

Discussion:
This trial will provide evidence of efficacy, acceptability and mechanisms of action of a rapid microbiological point-of-care test on antibiotic prescribing and patient symptoms in primary care.

Trial Registration:
ISRCTN16039192, prospectively registered on 08/11/2022.

Original languageEnglish
Article numbere0302302
Number of pages18
JournalPLoS ONE
Volume19
Issue number5
DOIs
Publication statusPublished - 20 May 2024

Bibliographical note

Publisher Copyright:
© 2024 Abbs et al.

Structured keywords

  • Health and Wellbeing (Psychological Science)
  • HEHP@Bristol

Keywords

  • Humans
  • Anti-Bacterial Agents/therapeutic use
  • Primary Health Care
  • Point-of-Care Testing
  • Respiratory Tract Infections/drug therapy
  • Randomized Controlled Trials as Topic
  • Female
  • Antimicrobial Stewardship/methods
  • Male
  • Point-of-Care Systems

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