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临床试验/NCT01913860
NCT01913860已完成不适用

Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle): Protocol for a Randomised Complex Intervention

National University of Ireland, Galway, Ireland1 个研究点 分布在 1 个国家目标入组 2,577 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,577
试验地点
1
主要终点
Relative number of prescriptions of first line antimicrobials

研究概览

简要总结

Background The over use of antimicrobials is recognised as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens. Urinary Tract Infections (UTIs) are one of the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended. Previous research has identified that a substantial proportion of Irish GPs prescribe antimicrobials for UTI that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland.

Aim To design, implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult (18 years of age and over) patients' antimicrobial consumption when presenting with a suspected UTI.

Methods The SIMPLE study is a randomised three armed intervention with practice level randomisation. Adult patients presenting with suspected UTI in primary care will be included in the study.

The intervention integrates components for both GPs and patients. For GPs the intervention includes interactive workshops, audit and feedback reports and automated electronic prompts summarising recommended first line antimicrobial treatment and, for one intervention arm, a recommendation to consider delayed antimicrobial prescribing. For patients multimedia applications and information leaflets are included. A minimum of 920 patients will be recruited through 30 practices. The primary outcome is change in prescribing of first line antimicrobials in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The intervention will take place over 15 months. Data will be collected through a remote electronic anonymised data extraction system (iPCRN), a text messaging system and through GP and patient interviews and surveys. The intervention will be strengthened by the implementation of a social marketing framework and an economic evaluation.

详细描述

Today, 80% of antimicrobial prescribing takes place in the community by general practitioners (GPs). Ireland is one of only three countries in Europe where the level of outpatient antimicrobial prescribing is increasing. Within this context, the inappropriate and overprescription of antimicrobials by GPs is a recognized factor contributing to the spread of AMR. The Guidelines for Antimicrobial Prescribing in Primary Care in Ireland provide advice on the selection of antimicrobial drugs for common infections and recommend the use of specific antimicrobials, with reserved drugs for more serious infections. However, despite the widespread availability of these guidelines, recent research has identified that less than 40% of outpatient prescriptions for urinary tract infections (UTIs) are made out according to first-line recommendations.

Urinary tract infections are predominantly caused by a bacteria; Escherichia coli, and are generally treated empirically, prior to the results of antimicrobial susceptibility testing. Antimicrobial resistance is now a critical factor in the treatment of UTIs, the second most common bacterial infection in primary care.

Social marketing is the conceptual framework that guided the development of this intervention. Formative (qualitative) research explored the culture of antimicrobial prescribing from both the GP's and the patient's perspective. Through a series of interviews with GPs (n = 15) and focus groups with patients (n = 35), the predictors of a GP's decision to prescribe an antimicrobial and the patient's expectation to receive an antimicrobial were explored.

The aim of SIMPle was to design, implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult (18 years of age and over) patients' antimicrobial consumption when presenting with a suspected UTI. The primary outcome was to increase the number of first-line antimicrobial prescriptions, as recommended in the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland (2011), for suspected UTIs in primary care by 10% in adult patients.

Methods The cluster for this intervention is the practice, and all GPs within each practice will be invited to participate. The baseline population for recruitment of patients will be formed by all practices in the West of Ireland who submit urine samples to the Galway University Hospitals (GUH) laboratory. The most popular patient management software system was chosen, because the SIMPle study builds on remote data extraction, the provision of audit and feedback reports and computer prompts integrated within the GP's patient management software system. This study will be undertaken in four phases: Phase 1, baseline data collection; Phase 2, GP intervention; Phase 3, patient intervention and Phase 4, endpoint data collection. Computerized remote data extraction is facilitated by the Irish Primary Care Research Network (iPCRN) and patient data are identified through the appropriate coding of suspected UTI consultations in the patient management software system. To promote and encourage consultation coding, which is currently not routine practice, the intervention will be preceded by a coding workshop at the beginning of Phase 1. All practices will be required to register with the iPCRN during or before the coding workshop. Practices will be monitored for two months after the delivery of the workshop to establish uptake of coding, whilst also facilitating a baseline data collection period (Phase 1). Phase 2 will begin with an interactive workshop (intervention arms A and B), which will introduce the intervention components specific to each arm. Phase 3 will see the roll-out of the patient education in all of the practices. The antimicrobial prescribing within each practice will be monitored for six months during Phases 2 and 3 through audit and feedback reports. Evaluation of the impact of the intervention will be carried out in Phase 4.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • All adult patients presenting with a suspected urinary tract infection to their general practitioner (GP)

排除标准

  • 未提供

结局指标

主要结局

Relative number of prescriptions of first line antimicrobials

时间窗: 3 and 9 months

Increase in the relative number of prescribing (over all UTI consultations) of first line antimicrobials as recommended in the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland (2010), for suspected UTI in primary care by 10% in adult patients.

次要结局

  • Relative number of antimicrobial prescriptions for UTI(3 and 9 months)
  • Number of delayed prescriptions for UTI(3 and 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akke Vellinga

Senior Lecturer Primary Care

National University of Ireland, Galway, Ireland

研究点 (1)

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