Best Assessment of Sore Throat and Antibiotic Prescribing (BASTA)

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.

Study Overview

• Status: Recruiting
• Conditions: Pharyngitis
• Intervention / Treatment: Behavioral: Physicians assess patients; Behavioral: Nurses assess patients; Behavioral: Pharmacists assess patients

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 Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carl Wikberg, PhD; Phone Number: +46703821660; Email: carl.wikberg@allmed.gu.se

Study Locations

• Sweden
  • Stenungsund, Sweden, 4430
    • Recruiting
    • Apoteket
    • Contact: Mina Khalil
  • Stenungsund, Sweden, 44430
    • Recruiting
    • Närhälsan Stenungsund Vårdcentral
    • Contact: Annelie Jardek
  • Ulricehamn, Sweden, 52337
    • Recruiting
    • Praktikertjänst Hälsobrunnen Vårdcentral
    • Contact: Dennis Johansson
  • Ulricehamn, Sweden
    • Recruiting
    • Apoteksgruppen
    • Contact: Sofia Pihlgren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Active Comparator: Initial assessement by physicians; 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
Experimental: Initial assessement by pharmacists; Patients attending with an acute sore throat are initially assessed by a pharmacist. This is officially not standard practice in Sweden, although it happens.	Behavioral: Pharmacists assess patients; Pharmacists are asked to assess patients following the current Swedish guideline

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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Göteborg University
• Investigators: Principal Investigator: Ronny Gunnarsson, PhD, University of Gothenburg and Region Vastra Gotaland

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Physicians; Guideline; Sore throat; Nurses; Pharmacy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis
• Other Study ID Numbers: U1111-1299-3543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No