跳至主要内容
临床试验/NCT04602676
NCT04602676已完成不适用

The Acceptability and Impact of Diarrheal Etiology Prediction (DEP) Algorithm Among Physicians Treating Children With Diarrhea

University of Utah2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2020年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Proportion of antibiotic prescriptions given to patients with diarrhea

研究概览

简要总结

This is a randomized crossover study, where clinicians will be randomized to periods where they will use a rehydration calculator application with or without the Diarrheal Etiology Prediction (DEP) algorithm. The crossover will include a washout period to reduce carryover effect. The study will be conducted over a 9-week period. The Investigators will use a random number generator to randomize clinicians to DEP (use of the etiology calculator) or control arm (use of a previously-tested rehydration calculator) within site for the first 4 weeks. After the first 4 weeks, there will be 1-week washout period without decision support, after which each clinician will cross-over to the other arm for the next 4 weeks.

The Investigators will enroll diarrhea-treating clinicians who treat children presenting with acute diarrhea at sites in Bangladesh and Mali. Utah investigators will only analyze de-identified data provided by our collaborators in Bangladesh and Mali.

详细描述

Diarrhoeal diseases are a leading cause of morbidity and mortality in children worldwide, with an estimated one billion cases and 500,000 deaths annually. While the majority of deaths due to diarrhoea occur in lower-income countries, infectious diarrhoea remains a significant problem in high-income countries. Aside from the immediate morbidity, potential long-term sequelae of diarrhoea in children in low-resource settings include malnutrition, growth faltering, and deficits in cognitive development.

While the cornerstone of diarrhoeal disease management in children is rehydration, a number of other management decisions, including the use of antibiotics and laboratory testing, may impact the course of disease. Overuse of antibiotics may cause side-effects and lead to increased antimicrobial resistance in the community. Underuse of antimicrobials for some bacterial and protozoal pathogens may lead to prolonged duration of illness and facilitate transmission. This can result in increased days of school or parental work missed, and among malnourished children in resource-poor settings, potential for growth faltering or death. Overuse of laboratory testing may have financial impact on both the patient and the healthcare system, and underuse may delay appropriate therapy or prevent recognition of outbreaks. Thus, accurate and cost-effective determination of diarrhoea etiology is important for proper case management in children and for public health.

Clinical prediction rules (CPRs) help clinicians interpret clinical information and can improve decision making. A recent systematic review showed that out of 137 studies of conditions for which clinical prediction rules have been developed for children only 2 were for diarrhoea, both of which are for the assessment of dehydration. Similarly, the majority of available guidelines for pediatric diarrhoea are focused on the route, timing, and choice of fluids for rehydration. A few studies in the past 30 years studied the use of clinical predictors to estimate the probability of a bacterial cause of diarrhoea. However, these studies were limited by low rates of pathogen identification, small sample sizes, use of a single study site, and suboptimal prediction performance.

Given the lack of guidelines and effective clinical predictors, decisions for use of antibiotics and laboratory testing are mostly empiric in nature, based on a number of "rules of thumb" for which evidence is scant. Unfortunately, physician judgment does very poorly to predict both need for antibiotics and correct type of testing. A recent study of children presenting to Kenyan hospitals with diarrhoea showed that reliance on dysentery as a proxy for Shigella infection led to the failure to diagnose Shigellosis in nearly 90% of cases. Better tools for decision making and evidence-based guidelines regarding use of antibiotics and laboratory testing in children with diarrhoea are clearly needed.

The majority of decisions for use of antibiotics in diarrhoeal illnesses are made empirically. In lower- and middle-income countries (LMICs), due to cost constraints, etiological diagnosis is rarely made, and a large number (up to 70%) of patients with acute diarrhoea are prescribed antibiotics. However, in contrast to high resource settings, bacterial pathogens may be very common in low resource settings. In the multicenter Global Enteric Multicenter Study (GEMS) study, the investigators found that detection of Shigella ranged from 16-78% of children with dysentery and 2-43% of children with watery diarrhoea. In both high and low resource settings, inappropriate use of antimicrobials leads to unnecessary toxicity for the individual, increased costs and an increase in antibiotic resistance in the community. Thus, methods for guiding appropriate use of antibiotics for pediatric diarrhoea in both high- and low-resource settings are urgently needed.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Planning to leave the study site prior to completion of the research
  • Inability to read

结局指标

主要结局

Proportion of antibiotic prescriptions given to patients with diarrhea

时间窗: 9 weeks

次要结局

  • Proportion of patients with resolution of diarrheal symptoms at 10-days after enrollment(10 days)
  • Clinician satisfaction towards use of the DEP as assessed by pre- and post-study questionnaires.(9 weeks)

研究者

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

Daniel Leung

Associate Professor

University of Utah

研究点 (2)

Loading locations...

相似试验