Clinical trial NCT06114706: Best Assessment of Sore Throat and Antibiotic Prescribing
Official title: Best Assessment of Sore Throat and Antibiotic Prescribing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pharyngitis
Keywords: Guideline
Sore throat
Pharmacy
Nurses
Physicians
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2023-11-02
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups each with different interventions.
Primary purpose: TREATMENT

Brief summary: This project aims to investigate if an organisational change of patient flow away from medical practitioners can reduce unnecessary antibiotic prescribing in patients attending with a sore throat as the main complaint.

Detailed description: Today patients appear either at a PHC centre or at the Pharmacy. The Pharmacy may provide advice on analgesic or refer the patient to a PHC centre. At the PHC centre, the patient may first appear to the medical practitioner or a nurse pending on local routines. The current Swedish guideline recommends no antibiotics and no testing for patients with 0-2 Centor criteria. For patients with 3-4 Centor criteria the guideline recommends testing and only consider antibiotics if GAS is present.

COVID-19 has gradually transformed from expressing itself as a severe lower respiratory tract infection to be more of an upper respiratory tract infection. Furthermore, COVID-19 is likely to transform from a pandemic to an endemic state with a low continuous incidence. Hence, in response to COVID-19 it seems crucial to identify to what extent the common sore throat is caused by the SARS-CoV-2.

Furthermore, a large controlled clinical trial is required to sort out if patients attending with a sore throat as the main complaint are best managed by medical practitioners, nurses or pharmacists. This study aims to perform such a controlled clinical trial comparing the outcome of sore throat patients management by medical practitioner, nurses and pharmacists. This study also aims to investigate to what extent the SARS-CoV-2 virus is identified in these patients.

Eligibility criteria: Inclusion Criteria:

* The patient is contacting/attending PHC centre or Pharmacy presenting with a sore throat as the main complaint.
* Male or female, aged ≥6 years.
* Fluent in Swedish (reading, writing, conversational) (applicable to caregivers/parents/guardians in case of children).
* Mental state such that he or she can understand and give informed consent to participation in the study by signing the Information and Consent Form.
* Provision of signed and dated Informed Consent Form.

Exclusion Criteria:

* The illness episode is classified as potentially complicated or potentially critically ill
* Presence of SARS-CoV-2 virus in a patient first appearing at the PHC in a cluster where the assessment is supposed to be done by the pharmacists. The patient will not be sent to the pharmacist in case of presence of SARS-CoV-2-virus.
* Patient request to be withdrawn from the study.

Primary outcomes:
measure: Guideline adherence
timeFrame: Immediately after the consultation
Secondary outcomes:
measure: Illness severity
timeFrame: Immediately after the consultation
measure: Type of patients seeking care
timeFrame: Immediately after the consultation
measure: Presence of SARS-CoV-2 virus
timeFrame: Immediately after the consultation
Other outcomes:
Locations:
city: Stenungsund
country: Sweden
facility: Apoteket
city: Stenungsund
country: Sweden
facility: Närhälsan Stenungsund Vårdcentral
city: Ulricehamn
country: Sweden
facility: Praktikertjänst Hälsobrunnen Vårdcentral
city: Ulricehamn
country: Sweden
facility: Apoteksgruppen
Study officials:
affiliation: University of Gothenburg and Region Vastra Gotaland
name: Ronny Gunnarsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: