跳至主要内容
临床试验/NCT03715062
NCT03715062已完成不适用

Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities With a Complex Intervention Targeted at Nursing Home Staff -A Protocol for a Cluster Randomized Controlled Trial.

Research Unit Of General Practice, Copenhagen2 个研究点 分布在 1 个国家目标入组 1,491 人开始时间: 2018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
已完成
发起方
入组人数
1,491
试验地点
2
主要终点
Prescription of antibiotics for urinary tract infection

研究概览

简要总结

This cluster randomized controlled study evaluates the effect of a tailored observation, reflection and communication tool on used by long-term care facility staff on antibiotic prescription for urinary tract infection in long-term care facility residents.

详细描述

Healthcare-associated infections due to antimicrobial use in long-term care facilities (LTCF) is an increasing problem in europe. It is well established that there exists a positive correlation between the amount of antibiotics used in treatment and resistant bacteria in both individual patients and society as a whole. A point-prevalence audit from 2017 in LTCFs showed that 10.5% of all LTCF residents in Denmark are treated with an antibiotic agent. In 78% of the cases, the cause for treatment was urinary tract infection (UTI). In addition, this group of elderly are particularly vulnerable to healthcare-associated infections, drug interactions and adverse effects. Thus, there are persuasive reasons for reducing antibiotic use in this specific group.

In the diagnostic process for UTI in a LTCF resident, there are several non-clinical factors influencing the diagnosis and leading to unnecessary treatment. First, because of dementia, sequelae from apoplexies, difficulties walking and other ailments, the typical LTCF resident is unable to express symptoms clearly and attend the GPs office. Consequently, the diagnosis is based on observations made by LTCF staff, which are then communicated to the General Practitioner (GP). Second, the prevalence of asymptomatic bacteriuria is up to 50% in this particular group. Though several studies have found that asymptomatic bacteriuria is a benign condition, it continues to be treated. Third, unspecific symptoms such as mental status change, falls or decreased function are unlikely to be caused by UTI. However, unspecific symptoms are still driving diagnosis and treatment of UTI. These factors may influence diagnosis and treatment in the Danish LTCF setting and therefore, a significant portion of the prescribed antibiotics for UTI could be due to overtreatment.

There is some evidence suggesting that antibiotic stewardship programs focusing on education of LTCF staff decreases antibiotic prescriptions and increases adherence to guidelines. In addition, there is moderate evidence that the widely used communication tool ISBAR (Identification, Situation, Background, Analysis, Recommendation) improves patient safety by improving interprofessional communication especially when communicating over the phone. Thus, if LTCF staff were educated on relevant observation, how to approach ASB, unspecific symptoms and structured handover of clinical information, the impact of these factors on diagnosis and treatment of UTI in LTCF residents may decrease. Overall, antibiotic stewardship programs in LTCF are somewhat effective. However, most of these were targeted at prescribers only or prescribers and nurses and some were also prone to bias because of the choice of study design. At present, there exists no cluster Randomized Controlled Trials (cRCT) targeting only LTCF staff with nursing tasks through a combined education- and communication-centered intervention.

研究设计

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

盲法说明

Statistical analysis is masked.

入排标准

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

入选标准

  • LTCFs eligible for inclusion have common service areas with attending staff 24 hours a day and they cannot be specialized i.e. not psychiatric LTCFs or LTCFs for the blind, except for LTCFs specialized in dementia. The residents living in these types of facilities requires a level of care that typically ensures that the LTCF staff handles all contact with the GP on behalf of the resident, while the LTCF residents remains a somewhat homogenous group.
  • We include only social and health helpers, social and health assistants and nurses, who have a permanent contract at the LTCF and do day- or evening shifts for the educational session. It is optional for the LTCF to use the educational material to educate LTCF staff in nightshifts. However, a UTI is rarely observed and reported during the night, which is why we chose this pragmatic approach. Usually, if a UTI is suspected, the night shift will report to the day shift, who then reevaluates and contacts the GP if necessary. We also target the permanently employed, as they are the majority of employees with nursing responsibilities and set the standard for the temporary staff.
  • All incidents of suspected UTI in LTCF residents or antibiotic prescriptions for UTI must be registered. All registrations must be made on LTCF residents above 65 years of age and with a permanent address at the LTCF, otherwise the incidence of ASB is different than assumed in preparing the intervention.

排除标准

  • 未提供

研究组 & 干预措施

Intervention group

Experimental

Receives education in diagnosing urinary tract infection and use of observation, reflection and communication tool.

干预措施: Dialogue tool (Other)

Control group

No Intervention

No intervention

结局指标

主要结局

Prescription of antibiotics for urinary tract infection

时间窗: 17 weeks

The number of antibiotic prescriptions for urinary tract infections pr resident days

次要结局

  • Appropriate prescription of antibiotics for urinary tract infections(17 weeks)
  • Death(17 weeks)
  • Hospitalization(17 weeks)

研究者

发起方
Research Unit Of General Practice, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sif Helene Arnold

Medical Doctor

Research Unit Of General Practice, Copenhagen

研究点 (2)

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