NCT06114706

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Mar 2024Jun 2027

First Submitted

Initial submission to the registry

October 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

October 23, 2023

Last Update Submit

March 12, 2026

Conditions

Pharyngitis

Keywords

GuidelineSore throatPharmacyNursesPhysicians

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Illness severity

    Immediately after the consultation

  • Type of patients seeking care

    Immediately after the consultation

  • Presence of SARS-CoV-2 virus

    Immediately after the consultation

Study Arms (3)

Initial assessement by physicians

ACTIVE COMPARATOR

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

Initial assessement by nurses

ACTIVE COMPARATOR

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

Initial assessement by pharmacists

EXPERIMENTAL

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

Interventions

Physicians assess patientsBEHAVIORAL

Physicians are asked to assess patients following the current Swedish guideline

Initial assessement by physicians
Nurses assess patientsBEHAVIORAL

Nurses are asked to assess patients following the current Swedish guideline

Initial assessement by nurses
Pharmacists assess patientsBEHAVIORAL

Pharmacists are asked to assess patients following the current Swedish guideline

Initial assessement by pharmacists

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Apoteket

Stenungsund, 4430, Sweden

RECRUITING

Närhälsan Stenungsund Vårdcentral

Stenungsund, 44430, Sweden

RECRUITING

Praktikertjänst Hälsobrunnen Vårdcentral

Ulricehamn, 52337, Sweden

RECRUITING

Apoteksgruppen

Ulricehamn, Sweden

RECRUITING

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ronny Gunnarsson, PhD

    University of Gothenburg and Region Vastra Gotaland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Wikberg, PhD

CONTACT

+46703821660carl.wikberg@allmed.gu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel groups each with different interventions.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 2, 2023

Study Start

March 4, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(4)