BASTA: Best Assessment of Sore Throat and Antibiotic Prescribing

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06114706

Collaborator

Göteborg University (Other)

450

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharyngitis	Behavioral: Physicians assess patients Behavioral: Nurses assess patients Behavioral: Pharmacists assess patients	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Paralell groups each with different interventions.Paralell groups each with different interventions.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Best Assessment of Sore Throat and Antibiotic Prescribing

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Initial assessement by phycisians Patients attending with an acute sore throat are initially assessed by a physician. This is one variant of current standard practice.	Behavioral: Physicians assess patients Physicians are asked to assess patients following the current Swedish guideline
Active Comparator: Initial assessement by nurses Patients attending with an acute sore throat are initially assessed by a nurse. This is one variant of current standard practice.	Behavioral: Nurses assess patients Nurses are asked to assess patients following the current Swedish guideline
Experimental: Initial assessement by pharmacists Patients attending with an acute sore throat are initially assessed by a pharmacist. This is oficially not standard practice in Sweden, although it happens.	Behavioral: Pharmacists assess patients Pharmacists are asked to assess patients following the current Swedish guideline

Arm

Intervention/Treatment

Active Comparator: Initial assessement by phycisians

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

Behavioral: Physicians assess patients

Physicians are asked to assess patients following the current Swedish guideline

Active Comparator: Initial assessement by nurses

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

Behavioral: Nurses assess patients

Nurses are asked to assess patients following the current Swedish guideline

Experimental: Initial assessement by pharmacists

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

Behavioral: Pharmacists assess patients

Pharmacists are asked to assess patients following the current Swedish guideline

Outcome Measures

Primary Outcome Measures

Guideline adherence [Immediately after the consultation]
Will the proportion of patients attending for an uncomplicated acute sore throat being managed according to prevailing guidelines differ if the initial assessment is made by a medical practitioner, a trained nurse or a trained pharmacist

Secondary Outcome Measures

Illness severity [Immediately after the consultation]
What proportion of patients attending PHC centres or pharmacies are classified as apparently uncomplicated, potentially complicated or potentially critically ill
Type of patients seeking care [Immediately after the consultation]
Will patient characteristics differ if the patient first appears to the medical practitioner, a trained nurse or a trained pharmacist?
Presence of SARS-CoV-2 virus [Immediately after the consultation]
To what extent do patients attending Primary Health Care/Pharmacies due to an acute sore throat harbour the SARS-CoV-2 virus?

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts 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.