Arnold Sif Helene, Jensen Jette Nygaard, Kousgaard Marius Brostrøm, Siersma Volkert, Bjerrum Lars, Holm Anne
The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
JMIR Res Protoc. 2020 May 8;9(5):e17710. doi: 10.2196/17710.
Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis.
The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality.
The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period.
The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020.
The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI.
ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17710.
尿路感染(UTI)是疗养院使用抗生素处方的最常见原因。过度开处方会对接受治疗的患者以及疗养院中的其他居住者造成与抗生素相关的伤害。疗养院中的诊断过程很复杂,既存在与老年人群体相关的挑战性问题,也存在疗养院环境方面的问题。医生很少因疑似尿路感染而前往疗养院。因此,工作人员对尿路感染的了解和沟通技巧会影响诊断。
本研究的目的是描述一项整群随机对照试验,采用量身定制的综合干预措施,以提高疗养院工作人员对尿路感染的认识和沟通技巧,从而减少疗养院居民尿路感染的抗生素处方数量,同时不改变住院率和死亡率。
该研究描述了一项开放标签的整群随机对照试验,有两个平行组,分配比例为1:1。从丹麦首都地区抽取了22家符合条件的疗养院,对应1274名疗养院居民。干预组会收到一个对话工具,所有疗养院工作人员都要参加关于尿路感染的研讨会。该研究的主要结局指标是试验期间尿路感染的抗生素处方率、全因住院率、全因死亡率以及疑似尿路感染情况。
该试验于2019年4月结束。数据已收集并正在进行分析。我们预计该试验结果将于2020年秋季在同行评审期刊上发表。
本研究的最大优势在于随机设计、干预措施的量身定制以及获取医疗记录。潜在的局限性在于处方过程中的层级关系、霍桑效应以及通过尿路感染日记获取体征和症状数据存在偏差。该试验结果可能提供一种策略,以克服抗生素耐药性增加带来的一些挑战,并可能对如何处理疑似尿路感染病例产生影响。
ClinicalTrials.gov NCT03715062;https://clinicaltrials.gov/ct2/show/NCT03715062。
国际注册报告识别号(IRRID):DERR1-10.2196/17710。