Best Assessment of Sore Throat and Antibiotic Prescribing

Study Overview
=================
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.

Official Title
-----------------
Best Assessment of Sore Throat and Antibiotic Prescribing

Conditions
-----------------
Pharyngitis

Intervention / Treatment
-----------------
* Behavioral: Physicians assess patients
* Behavioral: Nurses assess patients
* Behavioral: Pharmacists assess patients


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Paralell groups each with different interventions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Initial assessement by phycisians<br>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<br>* Physicians are asked to assess patients following the current Swedish guideline<br>|
| Active Comparator: Initial assessement by nurses<br>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<br>* Nurses are asked to assess patients following the current Swedish guideline<br>|
| Experimental: Initial assessement by pharmacists<br>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<br>* Pharmacists are asked to assess patients following the current Swedish guideline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guideline adherence | 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 | Immediately after the consultation | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Guideline, Sore throat, Pharmacy, Nurses, Physicians