Best Assessment of Sore Throat and Antibiotic Prescribing

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Physicians assess patients
  Physicians are asked to assess patients following the current Swedish guideline
• Поведенческое Nurses assess patients
  Nurses are asked to assess patients following the current Swedish guideline
• Поведенческое Pharmacists assess patients
  Pharmacists are asked to assess patients following the current Swedish guideline

Первичные конечные точки

• Guideline adherence [Срок оценки: Immediately after the consultation]

Вторичные конечные точки (3)

• Illness severity [Срок оценки: Immediately after the consultation]
• Type of patients seeking care [Срок оценки: Immediately after the consultation]
• Presence of SARS-CoV-2 virus [Срок оценки: Immediately after the consultation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 4 центра

• Apoteket — Stenungsund
• Närhälsan Stenungsund Vårdcentral — Stenungsund
• Praktikertjänst Hälsobrunnen Vårdcentral — Ulricehamn
• Apoteksgruppen — Ulricehamn

Идентификаторы

NCT: NCT06114706 · U1111-1299-3543

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗