跳至主要内容
临床试验/NCT06706583
NCT06706583招募中不适用

Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews. A Cluster Randomized Clinical Trial (TELÉMACO Trial)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月1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
入组人数
30
试验地点
1
主要终点
Total antimicrobial consumption

研究概览

简要总结

Brief Summary: Open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a Primary Care ASP based on telematic educational interviews.

详细描述

The objective of this project is to measure the effect of an Antimicrobial Stewardship Program (ASP) in Primary Care, based on an educational intervention.

This will consist of periodic structured telematic educational interviews between Infectious Diseases experts and Family Medicine and paediatrics specialists. In these interviews, the principles for the optimal use of antimicrobials will be addressed on real cases, analyzing together prescriptions randomly chosen from the Primary Care physician himself.

The repetition over time of key pedagogical messages for the optimisation of prescriptions is expected to improve the quality of antibiotic use, reduce the overall consumption, improve the use of microbiological tests, reduce the incidence of community infections caused by resistant microorganisms, and preserve patients' safety measured by the rate of admission for serious infections.

The results derived from these educational interventions, in the framework of a multimodal ASP, have been evaluated in hospital and Primary Care settings in quasi-experimental studies with a favourable outcome, but not in a clinical trial that specifically assesses the efficacy of educational interviews and avoids the bias of uncontrolled studies. To demonstrate this hypothesis, a cluster randomized trial has been designed, in wich all healthcare centers will be assigned either to a control group (the standard measures defined by the regional ASP PIRASOA will be maintained), and an experimental group (whose physicians will receive the educational intervention described).

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •a) Primary Care centres within the reference area of the University Hospital Virgen del Rocío.

排除标准

  • •Emergency departments.
  • •Odontology offices.
  • •DDD per Health centre less than 5.78

研究组 & 干预措施

Enhanced education arm

Experimental

Telematic educational interviews are added to standard PIRASOA training

干预措施: Telematic educational interviews + standard training (Behavioral)

Standard education arm

Active Comparator

Only standard PIRASOA training is provided

干预措施: Standard training (Behavioral)

结局指标

主要结局

Total antimicrobial consumption

时间窗: Monthly over a 36-month period

Total antimicrobial antimicrobial will be measured using the recommended international standard, the Defined Daily Dose (DDD) per 1000 inhabitants per day. Predefined subgroup analyses will be conducted to assess the intervention\'s effect on the primary outcome based on: patient age, geneder, and socioeconomic level.

次要结局

  • Adequacy of antimicrobial prescriptions(Prevalence surveys will be performed at months +0, +7 and +15.)
  • Incidence density of hospitalizations due to infections(Monthly, over a 36-month period.)
  • Incidence density of resistant Enterobacterales in urine cultures(Monthly, over a 36-month period.)

研究者

研究点 (1)

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