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临床试验/NCT06114706
NCT06114706招募中不适用

Best Assessment of Sore Throat and Antibiotic Prescribing

Vastra Gotaland Region4 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2024年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
4
主要终点
Guideline adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Physicians assess patients (Behavioral)

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.

干预措施: Nurses assess patients (Behavioral)

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.

干预措施: Pharmacists assess patients (Behavioral)

结局指标

主要结局

Guideline adherence

时间窗: 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

次要结局

  • Type of patients seeking care(Immediately after the consultation)
  • Presence of SARS-CoV-2 virus(Immediately after the consultation)
  • Illness severity(Immediately after the consultation)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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