Common illnesses including respiratory infections (upper respiratory tract infections [URTIs] and lower respiratory tract infections [LRTIs]), urinary tract infections (UTIs), skin infections and insect bites. Infections and Infestations
Conditions
Interventions
Triage and referral of patients with common illnesses from GP practices to linked pharmacies, who will use diagnostic aids and point-of-care tests where indicated.
The intervention will include evid
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients presenting to ‘index’ general practices with the commonest acute uncomplicated infections including: 1. UTI (women aged 16-65 years) 2. URTI: (adults aged 18-79 years and children aged 1-17 years): sore throat/otitis-media/sinusitis/influenza 3. LRTI: (adults aged 18-79 years and children aged 3-17 years) 4. Skin infections (adults aged 18-79 years and children aged 1–17 years with impetigo and insect bites)
Exclusion criteria
Exclusion criteria: 1. Infection not suspected 2. Pregnancy 3. Known immunological deficiencies 4. Symptoms of serious illness such as rapid deterioration in consciousness level; too unwell to walk 5. Aged under 1 year old or aged under 3 years with suspected UTI 6. Over age 75 years old with 2 or more major co-morbidities 7. Aged > 80 years old 8. Those who do not accept referrals to the partner pharmacies 9. Recurrent/chronic infection defined as: 9.1. LRTI: 2 or more infections in the last year 9.2. UTI: 2 or more episodes in the last 6 months or 3 or more in the last 12 9.3. Impetigo: 2 or more episodes in the last year 9.4. Chronic sinusitis (symptoms for >= 12 weeks) 9.5. Otitis: more than one infection in the last year in adults (aged > 16) and 3 or more/6 months or 4 or more in 12 months in children
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary feasibility outcome measures include: 1. To establish recruitment methods for a future definitive trial by evaluating recruitment and retention of pharmacies and GP practices in a range of UK geographical and sociodemographic regions. Data collected will include numbers invited, responded, initiated, completed/withdrawn, and reasons for not taking part at each stage, at the end of the study. 2. To establish the feasibility of cluster randomisation by evaluating recruitment of pharmacies/GP practices clusters and acceptability of randomisation to intervention and control arms through qualitative interviews with pharmacy and practice staff after randomisation, during and at the end of the study 3. To determine the feasibility of the triage/referral pathway from GP practices to their linked cluster pharmacy, by establishing: i) time taken, staff requirements, and resources used to triage and manage infections in both the general practices and pharmacies; ii) staffing requirements including time and resource required for training, monitoring and supporting pharmacy staff iii) referral rates to and from pharmacies, referrals to pharmacies not made, and referrals from pharmacies to hospitals. Data will be recorded directly by GP practice and pharmacy staff, qualitative interviews, and through the digital intervention, during and at the end of the study. 4. To establish patient recruitment and consent to i) the main study period and ii) the more intensive audit period, through numbers approached, referred, and consented to the trial collected by GP practice staff and pharmacists, by the digital intervention, and through qualitative interviews during and at the end of the study 5. To finalise data collection methods for primary and secondary outcomes by evaluating i) rates of completion of CRFs by pharmacists and GP practices through data from the digital intervention ii) rates of routine practice level antibiotic prescribing data through data from the RCGP Re | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcomes will be collected in preparation for a future definitive trial: 1. Experience of the intervention (decision-making tools and point-of-care tests), acceptability of the intervention, and trial materials, through qualitative process interviews conducted during and at the end of the study 2. Engagement with key behaviours – the use of online training; the use of decision support; and engagement with the in-practice audit through qualitative interviews and digital intervention usage data during and at the end of the study 3. Effects on antibiotic prescribing: i) Antibiotic prescribing rates at practice level for the key bundle of antibiotics; ii) Overall antibiotic prescribing at individual level, controlling for illness spectrum, iii) Antibiotic prescribing at individual level for each condition (e.g. LRTI, sore throat), iv) Appropriateness of antibiotic prescribing. Data will be collected through practice level and individual patient data (audit patients) at the end of the study. 4. Consultation rates and complication rates at practice level, through collection of practice level and individual patient data (audit patients) at the end of the study 5. Clinical safety (complications recorded; adverse events) of the triage/referral pathway, and use of the intervention/POCTs through collecting individual patient data (medical notes review and GP/pharmacy report) during and at the end of the study 6. Characteristics of participants in intervention and control practices through the collection of individual patient data at baseline and audit periods recorded by the digital intervention and through medical notes review at the end of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactJane;Sam Vennik;Williams
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Outcome results
None listed