Best Assessment of Sore Throat and Antibiotic Prescribing (BASTA)

Vastra Gotaland Region

Status: Enrolling

Conditions: Pharyngitis

Treatments: Behavioral: Physicians assess patients; Behavioral: Pharmacists assess patients; Behavioral: Nurses assess patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06114706

U1111-1299-3543

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Initial assessement by physicians

Active Comparator group

Description:

Patients attending with an acute sore throat are initially assessed by a physician. This is one variant of current standard practice.

Treatment:

Behavioral: Physicians assess patients

Initial assessement by nurses

Active Comparator group

Description:

Patients attending with an acute sore throat are initially assessed by a nurse. This is one variant of current standard practice.

Treatment:

Behavioral: Nurses assess patients

Initial assessement by pharmacists

Experimental group

Description:

Patients attending with an acute sore throat are initially assessed by a pharmacist. This is officially not standard practice in Sweden, although it happens.

Treatment:

Behavioral: Pharmacists assess patients