跳至主要内容
临床试验/NCT03901495
NCT03901495已完成不适用

Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study

Adrien Schwitzguebel2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Differential diagnosis established by the resident physician

研究概览

简要总结

Single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial.

In the intervention group only, resident physicians will be assisted by the automated medical history-taking device "Diaana" during their consultations in outpatient ambulatory unit of the Geneva University Hospital.

In both groups, the differential diagnosis of the resident physician will be compared to the gold-standard differential diagnosis of the senior physician.

详细描述

Automated medical history-taking devices (AMHTD) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. In this study, the investigators aimed to establish whether an AMHTD of interest, "Diaana", allowed the physician to establish a more precise differential diagnosis.

A single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial will be performed. No follow-up is necessary, because patients are seen once and all data are collected on this time. The study will take place in the emergency outpatient unit of Geneva University Hospital and include patients suffering from symptoms covered by Diaana.

Patients in the intervention group will fullfil Dianna. Then, the resident physician will read Diaana summary, perform his consultation, and fullfil case report form, including his differential diagnosis. Then, the senior physician will see the patient and establish the gold-standard differential diagnosis. In the control group, the residents will directely establish a differential diagnosis, without the help of Diaana.

研究设计

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

盲法说明

The first 50 eligible patients of the emergency outpatient unit in Geneva University Hospital are recruited into the control group (without access to "Diaana"). The next 50 eligible patients are recruited into the intervention group (with access to "Diaana").

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting to the emergency outpatient unit of Geneva University Hospital
  • Patients suffering from symptoms localized to the superior or inferior member, the back, hand the chest wall.

排除标准

  • Strictly dermatologic concerns
  • Toes and inversion ankle trauma (because the diagnosis of those conditions is generally obvious)
  • Medical condition considered as urgent
  • Inability to complete de digilatized Diaana form (sight problems, language, inability to use a tablet computer)

结局指标

主要结局

Differential diagnosis established by the resident physician

时间窗: At day 0

The resident physician will select up to 5 diagnose in an exhaustive list. The senior physician will do the same in order to establish the gold-standard differential diagnosis. The accuracy of the resident's differential diagnosis will be measured as the percentage of correct diagnose selected by the resident compared to the gold standard.

次要结局

  • Patient satisfaction(At day 0)
  • Consultation time(At day 0)
  • Differential diagnosis estabished by Diaana(At day 0)

研究者

发起方
Adrien Schwitzguebel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Adrien Schwitzguebel

Principal investigator, Independant physician

University Hospital, Geneva

研究点 (2)

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