Electronic intervention to reduce antibiotic prescribing (eCRT2 Study)
Research type
Research Study
Full title
Electronically delivered, multi-component intervention to reduce unnecessary antibiotic prescribing in primary care. Cluster randomised trial using electronic health records (eCRT2 Study)
IRAS ID
163504
Contact name
Martin Gulliford
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Design: Cluster randomised trial using the electronic health records (EHRs) of the Clinical Practice Research Datalink (CPRD).
Setting: General practices in England, Scotland, Wales and Northern Ireland.
Target population: General population of all ages.
Inclusion Criteria: All persons currently registered with participating CPRD general practices. Exclusions: none.
Health technology being assessed: There will be two trial arms. The Control trial arm practices will continue with usual clinical care. Practices in the Intervention trial arm will receive complex multi-component interventions, delivered remotely, as follows: i) feedback of each practice’s antibiotic prescribing results in relation to peers, through monthly updated antibiotic prescribing reports estimated from CPRD data; ii) delivery of educational and decision support tools to support policies of no-antibiotic prescribing or delayed prescribing; iii) ‘three minute webinars’ to explain and promote effective utilisation of the intervention materials. The intervention will continue for 12 months.
Measurement of costs and outcomes: Outcomes will be evaluated from CPRD EHRs. The primary outcome will be the number of antibiotic prescriptions for RTI per 1,000 patient years. Secondary outcomes will be: the RTI consultation rate; the proportion of consultations for respiratory tract infection (RTI) with an antibiotic prescribed; sub-groups of age; different categories of respiratory infections; and quartiles of intervention utilisation. Safety outcomes will be diagnoses of pneumonia and lower respiratory tract infection, peritonsillar abscess, mastoiditis, skin infections and bacterial infections. Total health care utilisation will be estimated from CPRD data, using methods reported previously, and compared between trial arms.
Sample size calculation: The 120 trial practices may include more than 1.2 million individual participants, allowing very precise estimation of cluster-level statistics. Family practice-specific proportions will be included in a cluster-level analysis, adjusting for pre-intervention values. There will be more than 80% power to detect an absolute reduction in antibiotic prescription for RTI of 12 per 1,000 registered patient years.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1730
Date of REC Opinion
23 Oct 2014
REC opinion
Favourable Opinion