Observation of early presentation and management of acute respiratory illness in the community Respiratory
Conditions
Interventions
Study design: We have developed two overarching protocols for the POS-ARI-PC. The POS-ARI-PC AUDIT protocol allows for a flexible annual anonymous prospective audit-type registration to describe the p
Sponsors
European Clinical Research Alliance for Infectious Diseases (Ecraid)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients will be of any age consulting (telephone, video, face to face) with a participating primary health care facility with: 1. Symptoms suggestive of an acute lower respiratory infection with cough as the predominant symptom, with illness duration less than 28 days, AND/OR 2. Symptoms suggestive of an acute upper respiratory infection with a sore throat and/or coryza as the predominant symptom, with illness duration of less than 14 days AND/OR 3. Other symptoms suggestive of COVID-19, Influenza, RSV 4. Participant or legal guardian(s) willing and able to provide informed consent and comply with study procedures Added 28/02/2024: POS-ARI-PC-001 Study: 1. Eligible patients will be 60 years of age and over consulting (telephone, video, or face-to-face in the practice, or home visit) with a participating primary health care facility with: 1.1. Symptoms suggestive of an acute lower RTI with new or increased cough as the predominant symptom, with illness duration <=7 days; AND/OR 1.2. Symptoms suggestive of an acute upper RTI with sore throat and/or coryza as the predominant symptoms, with illness duration <=7 days; AND 1.3. Willing and able to provide informed consent and have a swab taken Updated 24/10/2024: POS-ARI-PC-001 Study: Symptoms and Duration: Symptoms suggestive of an acute lower RTI with new or increased cough as the predominant symptom, with illness duration =10 days AND/OR Symptoms suggestive of an acute upper RTI with sore throat and/or coryza as the predominant symptom, with illness duration =10 days Age: Aged 60 years and over OR Aged 50 to 59 years and have a long-term health condition which makes them eligible for the yearly influenza vaccination under the national influenza vaccination programme Consent: Willing and able to provide informed consent and have a swab taken
Exclusion criteria
Exclusion criteria: Patients will not be eligible if: 1. According to the judgement of the recruiting clinician, they will not be able to comply with study procedures, for example, because they do not understand the language in which the study is being conducted locally (and have no one to help and translate for them); have a serious psychiatric disorder; or are terminally ill 2. Symptoms of presumed non-infective origin 3. Participant requires admission to the hospital on the day of inclusion. Additional in/exclusion criteria might apply to embedded studies and will be described in the SSA or ISA (added 28/02/2024) POS-ARI-PC-001 Study As per the POS-ARI-PC CORE Protocol, with one exception: patients needing hospitalisation can be recruited into the study if timing allows. Patients can provide a swab and decide not to participate in the follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feedback on details of treatment practices and trends across networks linked to patient outcomes: 1. Age bands, the proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI), and overall illness severity rating measured using an online CRF at the baseline visit 2. ARI diagnosis measured using retrospective viral/microbiological infection analysis (multiplex PCR) of swab samples taken at the baseline visit 3. Proportion undergoing POC (with results) and lab-based investigations measured using an online CRF at baseline visit and Day 28 4. Proportion given treatment and class of drug treatment for ARI measured using an online CRF at baseline visit and Day 28 5. Details of prescriptions given on presentation of ARI measured using an online CRF at baseline visit 6. Details of tests ordered on presentation of ARI measured at baseline visit using an online CRF 7. Return to usual daily activities, feeling recovered from RTI, use of prescription medication, complications, use of over-the-counter medications measured using an online CRF at the baseline visit, on Day 1-14 using a diary or on Day 14 using a telephone call, and Day 28 using an online CRF 8. Complications reported associated with ARI presentation measured using an online CRF at the baseline visit, on Day 1-14 using a diary or on Day 14 using a telephone call, and on Day 28 using an online CRF 9. Variation in practice and advice from national guidelines, to be fed back to national teams, measured using an online CRF at baseline visit and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients, measured using an interview conducted by the social science team after taking part in the main study and using a descriptive analysis at the end of the study 2. An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings, measured using an interview conducted by the social science team after taking part in the main study and using a descriptive analysis at the end of the study 3. An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials, measured using an interview conducted by the social science team after taking part in the main study and using a descriptive analysis at the end of the study 4. Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over the whole duration of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Harper
Outcome results
None listed